88 results on '"Fleshner PR"'
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2. Postoperative complications and waiting time for surgical intervention after radiologically guided drainage of intra-abdominal abscess in patients with Crohn's disease
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Harel Jacoby, Antonino Spinelli, Angela Mujukian, A Minaya, Francesco Colombo, C A Rodríguez, J Warusavitarne, S Alonso, Nir Horesh, Ali Yalcinkaya, M L M Karer, N N Uldall Nielsen, F. Di Candido, Philip Fleshner, M Pera, N Qvist, Gianluca M. Sampietro, H M Al-Qaisi, M Ellebæk, L Kunovsky, Uri Kopylov, M V Marino, A G Granero, Alaa El-Hussuna, O C Tatar, Matteo Frasson, N Sørensen, N Ladwa, A Zeb, Igors Iesalnieks, Gianluca Pellino, Valerio Celentano, L Hurtado-Pardo, C Steenholdt, El-Hussuna, A, Karer, M L M, Uldall Nielsen, N N, Mujukian, A, Fleshner, P R, Iesalnieks, I, Horesh, N, Kopylov, U, Jacoby, H, Al-Qaisi, H M, Colombo, F, Sampietro, G M, Marino, M V, Ellebæk, M, Steenholdt, C, Sørensen, N, Celentano, V, Ladwa, N, Warusavitarne, J, Pellino, G, Zeb, A, Di Candido, F, Hurtado-Pardo, L, Frasson, M, Kunovsky, L, Yalcinkaya, A, Tatar, O C, Alonso, S, Pera, M, Granero, A G, Rodríguez, C A, Minaya, A, Spinelli, A, Qvist, N, Institut Català de la Salut, [El-Hussuna A, Karer MLM, Uldall Nielsen NN] Department of Clinical Medicin, Aalborg University, Aalborg, Denmark. [Mujukian A, Fleshner PR] Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA. [Iesalnieks I] Department of Surgery, Städtisches Klinikum München Bogenhausen, Munich, Germany. [Pellino G] Servei de Cirurgia Colorectal, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania ‘Luigi Vanvitelli’, Naples, Italy, and Vall d'Hebron Barcelona Hospital Campus
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Percutaneous ,AcademicSubjects/MED00910 ,SURGERY ,Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases::Crohn Disease [DISEASES] ,Otros calificadores::Otros calificadores::/complicaciones [Otros calificadores] ,0302 clinical medicine ,Crohn Disease ,Retrospective Studie ,Abscess ,Bacterial Infections and Mycoses::Infection::Suppuration::Abscess::Abdominal Abscess [DISEASES] ,PREOPERATIVE OPTIMIZATION ,RISK ,Mortality rate ,Abscessos ,Abdominal Abscess ,General Medicine ,enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal::enfermedad de Crohn [ENFERMEDADES] ,3. Good health ,Waiting List ,030220 oncology & carcinogenesis ,Cohort ,PERCUTANEOUS DRAINAGE ,Drainage ,030211 gastroenterology & hepatology ,Original Article ,Female ,AcademicSubjects/MED00010 ,Human ,Adult ,medicine.medical_specialty ,Waiting Lists ,infecciones bacterianas y micosis::infección::supuración::absceso::absceso abdominal [ENFERMEDADES] ,03 medical and health sciences ,medicine ,Humans ,Other subheadings::Other subheadings::/diagnostic imaging [Other subheadings] ,Retrospective Studies ,Aged ,business.industry ,Abdominal Absce ,Otros calificadores::Otros calificadores::/diagnóstico por imagen [Otros calificadores] ,Retrospective cohort study ,Intra-abdominal Abscess ,Odds ratio ,medicine.disease ,Intestins - Inflamació - Complicacions ,Surgery ,business ,Other subheadings::Other subheadings::/complications [Other subheadings] ,INFLAMMATORY-BOWEL-DISEASE - Abstract
Background In patients with active Crohn’s disease (CD), treatment of intra-abdominal abscess usually comprises antibiotics and radiologically guided percutaneous drainage (PD) preceding surgery. The aim of this study was to investigate the risk of postoperative complications and identify the optimal time interval for surgical intervention after PD. Methods A multicentre, international, retrospective cohort study was carried out. Details of patients with diagnosis of CD who underwent ultrasonography- or CT-guided PD were retrieved from hospital records using international classification of disease (ICD-10) diagnosis code for CD combined with procedure code for PD. Clinical variables were retrieved and the following outcomes were measured: 30-day postoperative overall complications, intra-abdominal septic complications, unplanned intraoperative adverse events, surgical-site infections, sepsis and pathological postoperative ileus, in addition to abscess recurrence. Patients were categorized into three groups according to the length of the interval from PD to surgery (1–14 days, 15–30 days and more than 30 days) for comparison of outcomes. Results The cohort comprised 335 CD patients with PD followed by surgery. Median age was 33 (i.q.r. 24–44) years, 152 (45.4 per cent) were females, and median disease duration was 9 (i.q.r. 3.6–15) years. Overall, the 30-day postoperative complications rate was 32.2 per cent and the mortality rate was 1.5 per cent. After adjustment for co-variables, older age (odds ratio 1.03 (95 per cent c.i. 1.01 to 1.06), P < 0.012), residual abscess after PD (odds ratio 0.374 (95 per cent c.i. 0.19 to 0.74), P < 0.014), smoking (odds ratio 1.89 (95 per cent c.i. 1.01 to 3.53), P = 0.049) and low serum albumin concentration (odds ratio 0.921 (95 per cent c.i. 0.89 to 0.96), P < 0.001) were associated with higher rates of postoperative complications. A short waiting interval, less than 2 weeks after PD, was associated with a high incidence of abscess recurrence (odds ratio 0.59 (95 per cent c.i. 0.36 to 0.96), P = 0.042). Conclusion Smoking, low serum albumin concentration and older age were significantly associated with postoperative complications. An interval of at least 2 weeks after successful PD correlated with reduced risk of abscess recurrence., The authors showed that the optimal time interval for surgery is at least 2 weeks after drainage of the abscess. They confirmed the findings of other studies that smoking, steroid treatment and low albumin concentration in peripheral blood increase the risk of postoperative.
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- 2021
3. Effectiveness of Oral Tofacitinib in Chronic Pouchitis: A Prospective, Open-Label Pilot Study.
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Syal G, Mishkin DS, Banty A, Lee S, Fontelera N, Hampton M, Ziring D, Fleshner PR, and Melmed GY
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- Humans, Pilot Projects, Prospective Studies, Female, Male, Adult, Chronic Disease, Administration, Oral, Middle Aged, Treatment Outcome, Protein Kinase Inhibitors therapeutic use, Protein Kinase Inhibitors administration & dosage, Piperidines administration & dosage, Piperidines therapeutic use, Pyrimidines administration & dosage, Pyrimidines therapeutic use, Pouchitis drug therapy, Pouchitis etiology
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- 2024
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4. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial.
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Yao LY, Parrish AB, Fleshner PR, and Zaghiyan KN
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- Humans, Female, Adult, Male, Middle Aged, Aged, Prospective Studies, Hemorrhoids surgery, Acetaminophen therapeutic use, Acetaminophen administration & dosage, Young Adult, Gabapentin therapeutic use, Gabapentin administration & dosage, Pain Management methods, Elective Surgical Procedures methods, Pain, Postoperative prevention & control, Pain, Postoperative drug therapy, Ambulatory Surgical Procedures methods, Enhanced Recovery After Surgery, Analgesics, Opioid therapeutic use, Analgesics, Opioid administration & dosage, Rectal Fistula surgery
- Abstract
Background: Few studies report outcomes for enhanced recovery pathways in ambulatory anorectal surgery. We hypothesize that an ambulatory anorectal enhanced recovery pathway with multimodal analgesia can reduce postoperative opioid use., Objective: To compare postoperative opioid use in patients undergoing ambulatory anorectal surgery who receive multimodal analgesia versus standard of care without multimodal analgesia., Design: A prospective randomized trial of patients undergoing elective anal fistula or hemorrhoid surgery from September 2018 to May 2022., Setting: Urban teaching hospital., Patients: Adults aged 18 to 70 years undergoing elective anal fistula or hemorrhoid surgery from September 2018 to May 2022., Intervention: Multimodal enhanced recovery pathway including preoperative and postoperative nonopioid analgesia with oral acetaminophen, gabapentin, and ketolorac., Main Outcome Measures: Primary end point was oral opioid use during the first postoperative week. Secondary end points included maximum pain and nausea scores, adverse events, and emergency room or hospital admissions during the first 30 days postoperatively., Results: Of the 109 enrolled patients, 20 were lost to follow-up. The remaining 89 patients had a median age of 38 years (range, 20-67) and included 41 women (46%). There were no significant differences between the enhanced recovery protocol arm and non-enhanced recovery protocol arm in terms of preoperative and surgical characteristics. The primary end point of this study, that is, oral morphine milligram equivalents use during the first week, was significantly higher among patients in the non-enhanced recovery protocol arm (79 mg; range, 0-600) than patients in the enhanced recovery protocol arm (8 mg; range, 0-390; p = 0.002). On subgroup analysis, both fistula and hemorrhoid surgery patients assigned to the non-enhanced recovery protocol arm took significantly higher oral morphine milligram equivalents in the first week than patients in the enhanced recovery protocol arm. There was no significant difference in secondary end points., Limitations: Patients and providers were not blinded. Our findings are limited to hemorrhoid and fistula surgery and may not be applicable to other anorectal procedures., Conclusions: Enhanced recovery protocols including multimodal analgesia should be used in elective anal fistula and hemorrhoid surgery to decrease postoperative opioid use. See the Video Abstract ., Clinical Trial Registration: ClinicalTrials.gov ID NCT03738904., Implementacin De Protocolo De Recuperacin Acelerada Multimodal En Ciruga Anorrectal Ambulatoria Un Estudio Aleatorizado: ANTECEDENTES:Pocos estudios reportan resultados de programas de recuperación acelerada en la cirugía anorrectal ambulatoria. Presumimos que un programa anorrectal ambulatorio de recuperación acelerada con analgesia multimodal puede reducir el uso posoperatorio de opioides.OBJETIVO:Comparar el uso posoperatorio de opioides en pacientes sometidos a cirugía anorrectal ambulatoria que reciben analgesia multimodal versus atención estándar sin analgesia multimodal.DISEÑO:Un estudio prospectivo aleatorizado de pacientes sometidos a cirugía electiva de fístula anal o hemorroides desde septiembre de 2018 hasta mayo de 2022.LUGAR: Hospital universitario urbano.PACIENTES:Adultos de 18 a 70 años sometidos a cirugía electiva de fístula anal o hemorroides desde septiembre de 2018 hasta mayo de 2022.INTERVENCIÓN:Programa de recuperación acelerada multimodal que incluye analgesia no opioide pre y posoperatoria con paracetamol oral, gabapentina y ketoloraco.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue el uso de opioides orales durante la primera semana postoperatoria. Los resultados secundarios incluyeron puntuaciones máximas de dolor y náuseas, eventos adversos e ingresos a la sala de emergencias o al hospital durante los primeros 30 días después de la operación.RESULTADOS:De los 109 pacientes incluidos, 20 se perdieron durante el seguimiento. Los 89 pacientes restantes tenían una mediana de edad de 38 (rango, 20-67) años e incluían 41 (46%) mujeres. No hubo diferencias significativas entre los grupos del protocolo de recuperación acelerada (Grupo E) y del protocolo de recuperación no acelerada (Grupo NE) en términos de características preoperatorias y quirúrgicas. El resultado principal del estudio, el uso de MME oral durante la primera semana, fue significativamente mayor entre los pacientes del grupo NE (79 mg; rango: 0-600) que los pacientes del grupo E (8 mg; rango: 0-390) ( p = 0,002). En el análisis de subgrupos, los pacientes de cirugía de fístula y hemorroides asignados al grupo NE tomaron MME oral significativamente más alto en la primera semana que los pacientes del grupo E. No hubo diferencias significativas en los resultados secundarios.LIMITACIONES:Los pacientes y proveedores no fueron cegados. Nuestros hallazgos se limitan a la cirugía de hemorroides y fístulas y pueden no ser aplicables a otros procedimientos anorrectales.CONCLUSIONES:Se deben utilizar protocolos de recuperación acelerada que incluyan analgesia multimodal en la cirugía electiva de fístula anal y hemorroides para disminuir el uso posoperatorio de opioides. (Traducción- Dr. Francisco M. Abarca-Rendon )CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov ID NCT03738904., (Copyright © The ASCRS 2024.)
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- 2024
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5. Risk Factors for Microscopic Disease Positivity at Ileocolic Resection Margins for Crohn's Disease.
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Truong A, Chough J, Zaghiyan KN, and Fleshner PR
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- Humans, Male, Female, Risk Factors, Adult, Middle Aged, Young Adult, Crohn Disease surgery, Crohn Disease pathology, Crohn Disease epidemiology, Margins of Excision, Ileum surgery, Ileum pathology, Colon surgery, Colon pathology
- Abstract
Introduction: Interest in microscopic margin positivity during surgical resection of medical-refractory Crohn's disease has been renewed with multiple recent studies showing an association between microscopic margin positivity with disease recurrence. Our aim was to determine risk factors for microscopic margin disease positivity following ileocolic resection (ICR)., Materials and Methods: A prospectively-maintained database of patients with Crohn's disease undergoing ICR at a tertiary-referral center was queried. Margin positivity was defined as the presence of cryptitis, erosion, transmural inflammation with lymphoid aggregates, or architectural distortion at either ileal (proximal) or colonic (distal) margins., Results: Amongst 584 patients, 97 patients had a positive microscopic margin (17%) of which 46% had a positive proximal margin, 17% had a positive distal margin, and 13% had both positive and distal margins. Using multivariable logistic regression analysis, index ICR was associated with less odds of positive margin (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.24-0.89, p=0.02), and granuloma presence was associated with increased odds (OR 2.26, 95% CI 1.23-4.21, p=0.01)., Conclusion: We found that repeat ileocolic resection and granuloma presence were predictors of microscopic margin disease.
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- 2024
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6. Blinded Intraoperative Quantitative Indocyanine Green Metrics Associate With Intestinal Margin Acceptance in Colorectal Surgery.
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Adams ED, Salem JF, Burch MA, Fleshner PR, and Zaghiyan KN
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- Adult, Humans, Anastomosis, Surgical methods, Anastomotic Leak prevention & control, Cohort Studies, Fluorescein Angiography methods, Indocyanine Green, Prospective Studies, Colorectal Neoplasms surgery, Colorectal Surgery methods
- Abstract
Background: Indocyanine green is a useful tool in colorectal surgery. Quantitative values may enhance and standardize its application., Objective: To determine whether quantitative indocyanine green metrics correlate with standard subjective indocyanine green perfusion assessment in acceptance or rejection of anastomotic margins., Design: Prospective single-arm, single-institution cohort study. Surgeons viewed subjective indocyanine green images but were blinded to quantitative indocyanine green metrics., Setting: Tertiary academic center., Patients: Adults undergoing planned intestinal resection., Main Outcome Measures: Accepted perfusion and rejected perfusion of the intestinal margin were defined by the absence or presence of ischemia by subjective indocyanine green and gross inspection. The primary outcomes included quantitative indocyanine green values, maximum fluorescence, and time-to-maximum fluorescence in accepted compared to rejected perfusion. Secondary outcomes included maximum fluorescence and time-to-maximum fluorescence values in anastomotic leak., Results: There were 89 perfusion assessments comprising 156 intestinal segments. Nine segments were subjectively assessed to have poor perfusion by visual inspection and subjective indocyanine green. Maximum fluorescence (% intensity) exhibited higher intensity in accepted perfusion (accepted perfusion 161% [82%-351%] vs rejected perfusion 63% [10%-76%]; p = 0.03). Similarly, time-to-maximum fluorescence (seconds) was earlier in accepted perfusion compared to rejected perfusion (10 seconds [1-40] vs 120 seconds [90-120]; p < 0.01). Increased BMI was associated with higher maximum fluorescence. Anastomotic leak did not correlate with maximum fluorescence or time-to-maximum fluorescence., Limitations: Small cohort study, not powered to measure the association between quantitative indocyanine green metrics and anastomotic leak., Conclusions: We demonstrated that blinded quantitative values reliably correlate with subjective indocyanine green perfusion assessment. Time-to-maximum intensity is an important metric in perfusion evaluation. Quantitative indocyanine green metrics may enhance intraoperative intestinal perfusion assessment. Future studies may attempt to correlate quantitative indocyanine green values with anastomotic leak. See Video Abstract ., Las Mtricas Cuantitativas Intraoperatorias Ciegas Del Verde De Indocianina Se Asocian Con La Aceptacin Del Margen Intestinal En La Ciruga Colorrectal: ANTECEDENTES:El verde de indocianina es una herramienta útil en la cirugía colorrectal. Los valores cuantitativos pueden mejorar y estandarizar su aplicación.OBJETIVO:Determinar si las métricas cuantitativas de verde de indocianina se correlacionan con la evaluación subjetiva estándar de perfusión de verde de indocianina en la aceptación o rechazo de los márgenes anastomóticos.DISEÑO:Estudio de cohorte prospectivo de un solo brazo y de una sola institución. Los cirujanos vieron imágenes subjetivas de verde de indocianina, pero no conocían las métricas cuantitativas de verde de indocianina.AJUSTE:Centro académico terciario.PACIENTES:Adultos sometidos a resección intestinal planificada.PRINCIPALES MEDIDAS DE RESULTADO:La perfusión aceptada y la perfusión rechazada del margen intestinal se definieron por la ausencia o presencia de isquemia mediante verde de indocianina subjetiva y la inspección macroscópica. Los resultados primarios fueron los valores cuantitativos de verde de indocianina, la fluorescencia máxima y el tiempo hasta la fluorescencia máxima en la perfusión aceptada en comparación con la rechazada. Los resultados secundarios incluyeron la fluorescencia máxima y el tiempo hasta alcanzar los valores máximos de fluorescencia en la fuga anastomótica.RESULTADOS:Se realizaron 89 evaluaciones de perfusión, comprendiendo 156 segmentos intestinales. Se evaluó subjetivamente que 9 segmentos tenían mala perfusión mediante inspección visual y verde de indocianina subjetiva. La fluorescencia máxima (% de intensidad) mostró una mayor intensidad en la perfusión aceptada [Perfusión aceptada 161% (82-351) vs Perfusión rechazada 63% (10-76); p = 0,03]. De manera similar, el tiempo hasta la fluorescencia máxima (segundos) fue más temprano en la perfusión aceptada en comparación con la rechazada [10 s (1-40) frente a 120 s (90-120); p < 0,01]. Aumento del índice de masa corporal asociado con una fluorescencia máxima más alta. La fuga anastomótica no se correlacionó con la fluorescencia máxima ni con el tiempo hasta la fluorescencia máxima.LIMITACIONES:Estudio de cohorte pequeño, sin poder para medir la asociación entre las mediciones cuantitativas del verde de indocianina y la fuga anastomótica.CONCLUSIÓN:Demostramos que los valores cuantitativos ciegos se correlacionan de manera confiable con la evaluación subjetiva de la perfusión de verde de indocianina. El tiempo hasta la intensidad máxima es una métrica importante en la evaluación de la perfusión. Las métricas cuantitativas de verde de indocianina pueden mejorar la evaluación de la perfusión intestinal intraoperatoria. Los estudios futuros pueden intentar correlacionar los valores cuantitativos de verde de indocianina con la fuga anastomótica. (Traducción-Dr. Yolanda Colorado)., (Copyright © The ASCRS 2023.)
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- 2024
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7. End-to-end stapled technique for Kono-S anastomosis.
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Adams ED, Zaghiyan KN, and Fleshner PR
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- Humans, Anastomosis, Surgical methods, Surgical Staplers, Recurrence, Surgical Stapling, Crohn Disease surgery
- Abstract
Purpose: Our aim was to develop a Kono-S anastomotic technique using surgical staplers., Methods: Two patients underwent stapled Kono-S anastomosis, one via abdominal and one transanal approach., Results: The approach for an abdominal and transanal stapled Kono-S anastomosis is detailed., Conclusion: The Kono-S anastomosis can be safely configured using common surgical staplers., (© 2023. The Author(s).)
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- 2023
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8. Prospective Randomized Trial of Immediate Postoperative Use of Regular Diet Versus Clear Liquid Diet in Major Colorectal Surgery.
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Yao LY, Gough AE, Zaghiyan KN, and Fleshner PR
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- Humans, Diet, Prospective Studies, Colorectal Surgery, Ileus
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Background: Enhanced recovery protocols are becoming standard practice after major colorectal surgery. An increasing body of evidence suggests that early feeding should be encouraged; however, whether a clear liquid diet or solid diet should be given immediately after surgery is undetermined., Objective: Evaluate whether regular diet was superior to clear liquid diet beginning on postoperative day 0 after major colorectal surgery., Design: Superiority trial design., Setting: Urban tertiary center., Patients: Consecutive patients undergoing abdominal colorectal surgery from September 2017 to June 2018., Interventions: Eligible patients received either 1) clear liquid diet on postoperative day 0 with advancement to regular diet on postoperative day 1 or 2) regular diet on postoperative day 0 and continuing for the duration of patients' recovery., Main Outcome Measures: The primary end point was diet tolerance, defined by the absence of vomiting by postoperative day 2., Results: A total of 105 patients were randomly assigned with 53 in the clear liquid diet group and 52 in the regular diet group. All randomly assigned patients were included in the analysis. The rate of diet tolerance by postoperative day 2 was similar between groups. Rates of ileus, antiemetic usage, narcotic usage, time to return of bowel function, and pain/nausea/bloating scores were similar between the 2 groups. Significantly more patients in the clear liquid diet group (91%) tolerated their diet than did the regular diet group (71%) on postoperative day 0 ( p = 0.01)., Limitations: Diet tolerance was only monitored during inpatient stay. The rate of postoperative ileus was difficult to capture as its clinical definition encompassed a wide range of symptoms., Conclusions: Regular diet immediately after abdominal colorectal surgery was not superior to a clear liquid diet with respect to diet tolerance by postoperative day 2. Furthermore, starting regular diet on postoperative day 0 was not associated with any outcome benefits compared to clear liquid diet., Ensayo Prospectivo Aleatorizado Sobre El Uso Postoperatorio Inmediato De Una Dieta Normal Versus Una Dieta De Lquidos Claros En Cirugas Mayores Colorrectales: ANTECEDENTES:Los protocolos de recuperación mejorada se están convirtiendo en una práctica estandarizada tras una cirugía mayor colorrectal. La creciente evidencia sugiere la alimentación temprana debe ser estimulada, sin embargo, no se ha determinado si se debe administrar una dieta de líquidos claros o una dieta sólida inmediatamente después de la cirugía.OBJETIVO:Evaluar si la dieta regular fue superior a la dieta de líquidos claros a partir del día cero del postoperatorio tras una cirugía mayor colorrectal.DISEÑO:Diseño de prueba de superioridad.AJUSTE:Centro terciario urbano.PACIENTES:Pacientes consecutivos sometidos a cirugía abdominal colorrectal desde septiembre de 2017 hasta junio de 2018INTERVENCIONES:Los pacientes elegibles recibieron ya sea 1) dieta de líquidos claros en el día 0 del postoperatorio con avance a la dieta regular en el día 1 del postoperatorio o 2) dieta regular en el día 0 del postoperatorio y continuaron durante la recuperación de los pacientes.PRINCIPALES MEDIDAS DE RESULTADO:El criterio principal de valoración fue la tolerancia a la dieta, definida por la ausencia de vómitos en el segundo día posoperatorio.RESULTADOS:Un total de 105 pacientes fueron aleatorizados con 53 en el grupo de dieta de líquidos claros y 52 en el grupo de dieta regular. Todos los pacientes aleatorizados fueron incluidos en el análisis. La tasa de tolerancia a la dieta en el segundo día postoperatorio fue similar entre los grupos. Las tasas de íleo, del uso de antieméticos, del uso de narcóticos, del tiempo de recuperación de la función intestinal y puntajes de dolor/náuseas/distensión abdominal fueron similares entre los dos grupos. Significativamente más pacientes en el grupo de dieta de líquidos claros (91%) toleraron su dieta comparada al grupo de dieta regular (71%) en el día postoperatorio 0 ( p = 0,01).LIMITACIONES:La tolerancia a la dieta solo fue monitorizada durante la estadía hospitalaria. La tasa de íleo postoperatorio fue difícil de registrar debido a que su definición clínica abarcaba una amplia variedad de síntomas.CONCLUSIONES:La dieta regular inmediatamente después de la cirugía abdominal colorrectal no fue superior a una dieta de líquidos claros con respecto a la tolerancia de la dieta en el día 2 del postoperatorio. Además, comenzar una dieta regular el día cero del postoperatorio no se asoció con ningún beneficio en los resultados en comparación con la dieta de líquidos claros. (Traducción-Dr. Osvaldo Gauto )., (Copyright © The ASCRS 2023.)
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- 2023
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9. Preoperative CT Indices Predict Nonreach Before IPAA.
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Adams ED, Lansky CA, Kallman CE, Zaghiyan KN, and Fleshner PR
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- Humans, Retrospective Studies, Anastomosis, Surgical methods, Ileum, Tomography, X-Ray Computed, Postoperative Complications, Proctocolectomy, Restorative adverse effects, Proctocolectomy, Restorative methods
- Abstract
Background: IPAA aims to restore continence to patients after total proctocolectomy. However, some patients have inadequate small-bowel mesenteric length to achieve reconstruction. No preoperative risk stratification tools of native anatomy exist., Objective: We report CT-guided measurements of anatomic landmarks to predict nonreach before IPAA., Design: This is a single-institution retrospective analysis of a prospective database., Setting: This study was conducted at Cedars-Sinai between January 2007 and December 2021., Patients: Patients with IBD undergoing a 2- or 3-stage IPAA with a preoperative abdominal CT using either an enterography protocol or IV contrast sufficient to visualize mesenteric vasculature were included in the study. CT mesenteric indices were assessed, including total length (representing length required for the pouch to reach the anal canal), mesenteric length (inherent length of small-bowel mesentery), and mobilization length (the difference between total length and mesenteric length)., Main Outcome Measures: The primary outcome was IPAA nonreach. The secondary outcomes were association of clinical variables and CT mesenteric indices., Results: Six of 59 patients (10%) experienced nonreach. Mobilization length was longer in the nonreach group by 5.8 cm ( p = 0.01), and mesenteric length was shorter by 3.5 cm ( p = 0.04). Mobilization length ≥17 cm provided 100% sensitivity and 69% specificity (OR 1.46, area under the curve 0.84, p = 0.004) for nonreach. Similarly, a mesenteric length <14.6 cm demonstrated 100% sensitivity and 49% specificity for IPAA nonreach (area under the curve 0.75, p = 0.03)., Limitations: The retrospective nature of the study precluded a standardized imaging protocol. External validation will be required because of the small sample size., Conclusions: CT-based measurements of length, specifically mesenteric and mobilization length, predict nonreach before IPAA. This method is noninvasive, readily available, and may be useful for preoperative patient counseling and operative planning. See Video Abstract at http://links.lww.com/DCR/C140 ., Los Ndices De Tomografa Computarizada Preoperatoria Predicen La Ausencia De Alcance Antes De La Anastomosis Del Reservorio Ilealanal: ANTECEDENTES:La anastomosis del reservorio ileoanal tiene como objetivo restaurar la continencia en los pacientes después de una proctocolectomía total. Sin embargo, algunos pacientes tienen una longitud mesentérica del intestino delgado inadecuada para lograr la reconstrucción. No existen herramientas de estratificación del riesgo preoperatorio de la anatomía nativa.OBJETIVO:Informamos mediciones guiadas por tomografía computarizada de puntos de referencia anatómicos para predecir la falta de alcance antes de la anastomosis ileoanal con reservorio.DISEÑO:Este es un análisis retrospectivo de una sola institución de una base de datos prospectiva.AJUSTE:Este estudio se realizó en Cedars-Sinai entre Enero de 2007 y Diciembre de 2021.PACIENTES:Pacientes con enfermedad inflamatoria intestinal que se someten a una anastomosis anal con reservorio ileal en 2 o 3 etapas con una tomografía computarizada abdominal preoperatoria utilizando un protocolo de enterografía o contraste intravenoso suficiente para visualizar la vasculatura mesentérica. Se evaluaron los índices mesentéricos de tomografía computarizada, incluida la longitud total (que representa la longitud requerida para que la bolsa alcance el canal anal), la longitud mesentérica (longitud inherente del mesenterio del intestino delgado) y la longitud de movilización (la diferencia entre la longitud total y la longitud mesentérica).PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue falta de alcance de la anastomosis del reservorio ileoanal. Los resultados secundarios fueron la asociación de variables clínicas y los índices mesentéricos de tomografía computarizada.RESULTADOS:Seis de 59 (10%) pacientes experimentaron falta de alcance. La longitud de movilización fue mayor en el grupo sin alcance en 5,8 cm ( p = 0,01) y la longitud mesentérica fue menor en 3,5 cm ( p = 0,04). La longitud de movilización ≥17 cm proporcionó una sensibilidad del 100% y una especificidad del 69% (OR 1,46, AUC 0,84, p = 0,004) para la falta de alcance. De manera similar, una longitud mesentérica <14,6 cm demostró una sensibilidad del 100% y una especificidad del 49% para la falta de alcance de la anastomosis del reservorio ileoanal (AUC 0,75, p = 0,03).LIMITACIONES:La naturaleza retrospectiva del estudio impidió un protocolo de imágenes estandarizado. Se requerirá una validación externa debido al pequeño tamaño de la muestra.CONCLUSIONES:Las mediciones de longitud basadas en tomografía computarizada, específicamente la longitud mesentérica y de movilización, predicen la falta de alcance antes de la anastomosis anal con bolsa ileo. Este método no es invasivo, está fácilmente disponible y puede ser útil para el asesoramiento preoperatorio del paciente y la planificación quirúrgica. Consulte el Video Resumen en https://links.lww.com/DCR/C140 . (Traducción-Dr. Yesenia Rojas-Khalil )., (Copyright © The ASCRS 2023.)
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- 2023
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10. Watchful Waiting After Radiological Guided Drainage of Intra-abdominal Abscess in Patients With Crohn's Disease Might Be Associated With Increased Rates of Stoma Construction.
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El-Hussuna A, Steenholdt C, Merrild Karer ML, Nyggard Uldall Nielsen N, Mujukian A, Fleshner PR, Iesalnieks I, Horesh N, Kopylov U, Jacoby H, Al-Qaisi HM, Colombo F, Sampietro GM, Marino MV, Ellebæk M, Sørensen N, Celentano V, Ladwa N, Warusavitarne J, Pellino G, Zeb A, Di Candido F, Hurtado-Pardo L, Frasson M, Kunovsky L, Yalcinkaya A, Alonso S, Pera M, Rodríguez CA, Bravo AM, Granero AG, Tatar OC, Spinelli A, and Qvist N
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Background: Management of spontaneous intra-abdominal abscess (IAA) in patients with Crohn's disease (CD) with radiologically guided percutaneous drainage (PD) was debated., Methods: This is a secondary analysis from a multicenter, retrospective cohort study of all the patients with CD who underwent PD followed by surgery at 19 international tertiary centers., Results: Seventeen patients (4.8%) who did not undergo surgery after PD were compared to those who had PD followed by surgical intervention 335/352 (95.2%). Patients who had PD without surgery were those with longer disease duration, more frequently had previous surgery for CD (laparotomies/laparoscopies), enteric fistula, on steroid treatment before and continue to have it after PD. Patients who had PD without subsequent surgical resection had a higher risk of stoma construction at later stages 8/17 (47.1%) versus 90/326 (27.6%) ( P < .01). Patients with PD with no subsequent surgery had numerically higher rates of abscess recurrence 5/17 (29.4%) compared to those who had PD followed by surgery 45/335 (13.4%) the difference was not statistically significant ( P = .07)., Conclusions: Even with the low number of patients enrolled in this study who had PD of IAA without subsequent surgery, the findings indicate a markedly worse prognosis in terms of recurrence, length of stay, readmission, and stoma construction. Watchful waiting after PD to treat patients with spontaneous IAA might be indicated in selected patients with poor health status or poor prognostic factors., Competing Interests: C.S. received lecture fees from MSD. I.I. received lecture fees from AbbVie. The other authors declare no other conflict of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)
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- 2023
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11. Feasibility of opioid-free surgery for inflammatory bowel disease.
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Truong A, Yao L, Fleshner PR, and Zaghiyan KN
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- Humans, Retrospective Studies, Prospective Studies, Pain, Postoperative drug therapy, Pain, Postoperative etiology, Feasibility Studies, Morphine therapeutic use, Analgesics, Opioid therapeutic use, Inflammatory Bowel Diseases surgery
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Aim: Patients undergoing colorectal surgery or those with inflammatory bowel disease (IBD) are particularly at risk for opioid-related complications and progression to long-term opioid dependence. The aim of this work is to explore the real-world possibility of perioperative opioid avoidance in colorectal surgery and IBD., Method: We conducted a retrospective analysis of patients aggregated from two prospective studies on multimodal postoperative pain control conducted at a single tertiary referral centre. All patients underwent major colorectal surgery with bowel resection. Patients with chronic preoperative opioid use were excluded. Opioid use was measured in oral morphine equivalents (OME) each postoperative day (POD) and cumulatively for the first 72 h., Results: Our cohort of 209 patients included 148 (71%) with IBD and 61 (29%) non-IBD patients. IBD patients required significantly more opioids cumulatively over the first 72 postoperative hours compared with non-IBD patients [median OME 77 mg (interquartile range 33-148 mg) vs. 4 mg (interquartile range 17-82 mg), respectively; p = 0.001]. Five percent of IBD patients achieved opioid-free postoperative pain control during the entire 72 h postoperative period compared with 12% of non-IBD patients. Only 7% of IBD patients avoided opioid use on POD 1 compared with 20% of non-IBD patients (p = 0.02); however the number of IBD patients increased to 16% on POD 2 then 40% on POD 3, closely resembling the non-IBD cohort at 49% (p = 0.22)., Conclusion: In the era of modern enhanced recovery protocols and minimally invasive techniques, we show that early postoperative opioid avoidance is feasible in a limited number of IBD patients after colorectal surgery., (© 2023 Association of Coloproctology of Great Britain and Ireland.)
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- 2023
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12. Efficacy of Anal Sphincter Division During Fistulotomy in Anal Fissure-Associated Fistula.
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Adams ED, Mirocha JM, Fleshner PR, and Zaghiyan KN
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- Adult, Humans, Retrospective Studies, Anal Canal, Crohn Disease complications, Fissure in Ano, Rectal Fistula complications
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Background: A subset of chronic anal fissures beget focal infection, leading to concomitant fistula. The optimal management of fissure-associated fistula is unknown., Objective: This study aimed to characterize healing rates and effects of fistulotomy in fissure-associated fistula., Design: Retrospective study., Setting: Urban tertiary center., Patients: Adults who underwent fistulotomy for a fistula associated with a chronic anal fissure were included in the study. However, those with Crohn's disease, a history of lateral internal sphincterotomy, and a fistula not amenable to fistulotomy were excluded., Interventions: Patients were managed with fistulotomy. Fissures were otherwise managed conservatively with a step-up approach., Main Outcome Measures: The primary end point was healing, defined as resolution of symptoms and both fistula and fissure wounds within 1 year. Subgroup analysis compared those who underwent subcutaneous fistulotomy (group A) with those who underwent fistulotomy involving anal sphincter fibers (group B)., Results: Twenty-four of 38 patients (63%) healed with a median overall follow-up of 6.6 months (4.2-14.1). The overall median time to healing was 4.4 months (2.2-6.0). No clinical or pathologic factors predicted healing. In subgroup analysis, overall subcutaneous fistulotomy healing rates were nonstatically lower at 46% (6/13) compared to fistulotomy involving anal sphincter fibers at 72% (18/25; p = 0.16). There was no difference in time to healing (subcutaneous fistulotomy, 6.7 mo [5.2-8.4] vs fistulotomy involving sphincter, 5.1 mo [2.1-7.0]; p = 0.36)., Limitations: The limitations include treatment bias, with increased utilization of chemical sphincter-relaxing agents in those who did not heal. Findings are not applicable to complex fistulas, Crohn's disease, or atypical fissures., Conclusions: Patients presenting with chronic fissure and associated subcutaneous, intersphincteric, or low transphincteric fistula are successfully managed with fistulotomy. Patients with a subcutaneous fistula tract exhibited nonstatistically significantly lower rates of healing. See Video Abstract at http://links.lww.com/DCR/C145 ., Eficacia De La Divisin Esfintrica Durante La Fistulotoma En Casos De Fstula Asociada a Fisura Anal: ANTECEDENTES: Ciertos subgrupos de fisuras anales crónicas ocasionan infección localizada, induciendo la aparición de una fístula anal concomitante. Se desconoce el manejo óptimo de la fístula concomitante a una fisura anal.OBJETIVO: Se trata de caracterizar las tasas de curación y el efecto de la fistulotomía en el tratamiento de la fístula concomitante a la fisura anal.DISEÑO: Estudio retrospectivo.EMPLAZAMIENTO: Centro terciario urbano.PACIENTES: Adultos sometidos a fistulotomía por una fístula concomitante a una fisura anal crónica. Se excluyeron la enfermedad de Crohn, el antecedente de una esfinterotomía lateral interna y las fístulas no susceptibles de fistulotomía.INTERVENCIONES: Los pacientes fueron manejados con una fistulotomía clasica. Por lo demás, las fisuras se trataron de forma conservadora con un enfoque médico escalonado.PRINCIPALES MEDIDAS DE RESULTADO: El criterio principal de valoración fué la cura definitiva, determinada como la resolución completa de los síntomas y de las heridas tanto de la fístula como de la fisura en el plazo de un año. El análisis de los subgrupos comparó los que se sometieron a una fistulotomía subcutánea (grupo A) versus una fistulotomía que involucró las fibras del esfínter anal interno (grupo B).RESULTADOS: 24/38 pacientes (63%) curaron con una mediana de seguimiento global de 6,6 meses (4,2-14,1). El tiempo medio general de curación fue de 4,4 meses (2,2-6,0). Ningún factor clínico o patológico predijo la cura. En el análisis de subgrupos, las tasas generales de cura de la fistulotomía subcutánea no fueron estadísticamente más bajas de 46 % (6/13) comparados con la fistulotomía que involucró las fibras del esfínter anal interno en 72 % (18/25; p = 0,16). No hubo diferencia en el tiempo de cicatrización [fistulotomía subcutánea 6,7 meses (5,2-8,4) conparada a la fistulotomía y esfínterotomía parcial interna a 5,1 meses (2,1-7,0); p = 0,36].LIMITACIONES: Sesgo del tratamiento, con mayor utilización de agentes químicos relajantes de la musculatura esfínteriana en aquellos pacientes que no sanaron. No aplicable a fístulas complejas, enfermedad de Crohn o fisuras atípicas.CONCLUSIÓNES: Los pacientes que presentan fisura crónica y fístula subcutánea, inter-esfintérica o trans-esfintérica baja concomitante se manejan con éxito con una fistulotomía. Los pacientes con un trayecto de fístula subcutánea exhibieron tasas de curación más bajas y no estadísticamente significativas. Consulte Video Resumen en http://links.lww.com/DCR/C145 . (Traducción-Dr. Xavier Delgadillo )., (Copyright © The ASCRS 2023.)
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- 2023
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13. High Complication Rate After Early Ileostomy Closure: Early Termination of the Short Versus Long Interval to Loop Ileostomy Reversal After Pouch Surgery Randomized Trial.
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Vogel JD, Fleshner PR, Holubar SD, Poylin VY, Regenbogen SE, Chapman BC, Messaris E, Mutch MG, and Hyman NH
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- Adult, Humans, Ileostomy adverse effects, Prospective Studies, Retrospective Studies, Postoperative Complications etiology, Colitis, Ulcerative surgery, Proctocolectomy, Restorative adverse effects
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Background: In patients with ulcerative colitis who undergo IPAA, a diverting ileostomy is used to diminish the severity of anastomotic complications. Typically, the ileostomy is closed after an interval of 2 to 4 months. The safety of earlier closure of the ileostomy after pouch surgery is unknown., Objective: This study aimed to compare postoperative outcomes in patients randomly assigned to early (7-12 days) or late (≥8 weeks) ileostomy closure after ileal pouch construction., Design: This was a multicenter, prospective randomized trial., Setting: The study was conducted at colorectal surgical units at select United States hospitals., Patients: Adults with ulcerative colitis who underwent 2- or 3-stage proctocolectomy with IPAA were included., Main Outcome Measures: The primary outcomes included Comprehensive Complication Index at 30 days after ileostomy closure. The secondary outcomes included complications, severe complications, reoperations, and readmissions within 30 days of ileostomy closure., Results: The trial was stopped after interim analysis because of a high rate of complications after early ileostomy closure. Among 36 patients analyzed, 1 patient (3%) had unplanned proctectomy with end-ileostomy. Of the remaining 35 patients, 28 patients (80%) were clinically eligible for early closure and underwent radiologic assessment. There were 3 radiologic failures. Of the 25 remaining patients, 22 patients (88%) were randomly assigned to early closure (n = 10) or late closure (n = 12), and 3 patients were excluded. Median Comprehensive Complication Index was 14.8 (0-54) and 0 (0-23) after early and late closure (p = 0.02). One or more complications occurred in 7 patients (70%) after early closure and in 2 patients (17%) after late closure (p = 0.01)' and complications were severe in 3 patients (30%) after early closure and 0 patients after late closure (p = 0.04). Reoperation was required in 1 patient (10%) and 0 patients (p = 0.26) after early closure and readmission was required in 7 patients (70%) and 1 patient (8%) after late closure (p = 0.003)., Limitations: This study was limited by early study closure and selection bias., Conclusions: Early closure of a diverting ileostomy in patients with ulcerative colitis who underwent IPAA is associated with an unacceptably high rate of complications. See Video Abstract at http://links.lww.com/DCR/C68., Alta Tasa De Complicaciones Despus Del Cierre Precoz De La Ileostoma Terminacin Temprana Del Ensayo Aleatorizado De Intervalo Corto Versus Largo Para La Reversin De La Ileostoma En Asa Despus De La Ciruga De Reservorio Ileal: ANTECEDENTES:En los pacientes con colitis ulcerosa que se someten a una anastomosis del reservorio ileoanal, se utiliza una ileostomía de derivación para disminuir la gravedad de las complicaciones de la anastomosis. Por lo general, la ileostomía se cierra después de un intervalo de 2 a 4 meses. Se desconoce la seguridad del cierre más temprano de la ileostomía después de la cirugía de reservorio.OBJETIVO:Comparar los resultados posoperatorios en pacientes asignados al azar al cierre temprano (7-12 días) o tardío (≥ 8 semanas) de la ileostomía después de la construcción de un reservorio ileal.DISEÑO:Este fue un ensayo aleatorizado prospectivo multicéntrico.ESCENARIO:El estudio se realizó en unidades quirúrgicas colorrectales en hospitales seleccionados de los Estados Unidos.PACIENTES:Se incluyeron adultos con colitis ulcerosa que se sometieron a proctocolectomía en 2 o 3 tiempos con anastomosis ileoanal con reservorio.PRINCIPALES MEDIDAS DE RESULTADO:Los resultados primarios incluyeron el Índice Integral de Complicaciones a los 30 días después del cierre de la ileostomía. Los resultados secundarios incluyeron complicaciones, complicaciones graves, reoperaciones y readmisiones dentro de los 30 días posteriores al cierre de la ileostomía.RESULTADOS:El ensayo se detuvo después del análisis interino debido a una alta tasa de complicaciones después del cierre temprano de la ileostomía. Entre los 36 pacientes analizados, 1 (3%) tuvo una proctectomía no planificada con ileostomía terminal. De los 35 pacientes restantes, 28 (80%) fueron clínicamente elegibles para el cierre temprano y se sometieron a una evaluación radiológica. Hubo 3 fracasos radiológicos. De los 25 pacientes restantes, 22 (88 %) se asignaron al azar a cierre temprano (n = 10) o tardío (n = 12) y 3 fueron excluidos. La mediana del Índice Integral de Complicaciones fue de 14,8 (0-54) y 0 (0-23) después del cierre temprano y tardío (p = 0,02). Una o más complicaciones ocurrieron en 7 pacientes (70%) después del cierre temprano y 2 (17%) pacientes después del cierre tardío (p = 0,01) y fueron graves en 3 (30%) y 0 pacientes, respectivamente (p = 0,04). Requirieron reintervención en 1 (10%) y 0 (p = 0,26) y reingreso en 7 (70%) y 1 (8%) pacientes (p = 0,003).LIMITACIONES:Este estudio estuvo limitado por el cierre temprano del estudio; sesgo de selección.CONCLUSIONES:El cierre temprano de una ileostomía de derivación en pacientes con colitis ulcerosa con anastomosis de reservorio ileoanal se asocia con una tasa inaceptablemente alta de complicaciones. Consulte Video Resumen en http://links.lww.com/DCR/C68. (Traducción-Dr. Felipe Bellolio)., (Copyright © The ASCRS 2022.)
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- 2023
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14. Impact of postoperative telemedicine visit versus in-person visit on patient satisfaction: A randomized clinical trial.
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Yao LY, Fleshner PR, and Zaghiyan KN
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- Adult, Humans, Female, Adolescent, Male, Pandemics, Patient Satisfaction, Surveys and Questionnaires, COVID-19, Telemedicine
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Background: Although telemedicine use has increased dramatically during the COVID-19 pandemic and beyond, the impact of telemedicine versus in-person postoperative visits on patient satisfaction has not been studied prospectively. We hypothesized that telemedicine visits would be noninferior to in-person visits in terms of postoperative colorectal surgery patient satisfaction., Methods: We conducted a randomized trial of consecutive adult patients undergoing transabdominal colorectal surgery from September 2020 to February 2021. Eligible participants were randomized 1:1 to either receive a telemedicine visit (Arm T) or an in-person visit (Arm I) for their first postoperative appointment. Subsequently, participants in Arm T completed a second postoperative visit in person, and participants in Arm I completed a second postoperative visit via telemedicine. All participants completed a patient satisfaction survey electronically within 24 hours after each postoperative visit. The primary endpoint was total patient satisfaction score. Secondary endpoints included patient-reported safety score, length of visit, and willingness of patients to recommend the practice to their peers. Fisher's exact test, χ
2 analysis, and Student's t test were used to compare outcomes., Results: A total of 46 patients were analyzed with 23 each in Arm T and Arm I. The mean age of our study cohort was 50.6 (standard deviation 17.7) years and 52% were female. No significant differences were found between groups in terms of baseline characteristics. With respect to our primary endpoint of total satisfaction score, patient satisfaction scores in Arm T were non-inferior to those in Arm I. Similarly, there was no significant difference in satisfaction scores after the second postoperative visit when the visit types were reversed. We did not find any significant differences between groups in terms of our secondary endpoints., Conclusion: Postoperative telemedicine visits were a safe and time-efficient option that maintained high patient satisfaction compared with in-person postoperative visits., (Copyright © 2022 Elsevier Inc. All rights reserved.)- Published
- 2023
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15. CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease.
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Ma C, Hanzel J, Panaccione R, Sandborn WJ, D'Haens GR, Ahuja V, Atreya R, Bernstein CN, Bossuyt P, Bressler B, Bryant RV, Cohen B, Colombel JF, Danese S, Dignass A, Dubinsky MC, Fleshner PR, Gearry RB, Hanauer SB, Hart A, Kotze PG, Kucharzik T, Lakatos PL, Leong RW, Magro F, Panés J, Peyrin-Biroulet L, Ran Z, Regueiro M, Singh S, Spinelli A, Steinhart AH, Travis SP, van der Woude CJ, Yacyshyn B, Yamamoto T, Allez M, Bemelman WA, Lightner AL, Louis E, Rubin DT, Scherl EJ, Siegel CA, Silverberg MS, Vermeire S, Parker CE, McFarlane SC, Guizzetti L, Smith MI, Vande Casteele N, Feagan BG, and Jairath V
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- Biomarkers, C-Reactive Protein metabolism, Chronic Disease, Consensus, Humans, Leukocyte L1 Antigen Complex, Outcome Assessment, Health Care, Quality of Life, Randomized Controlled Trials as Topic, Colitis, Ulcerative diagnosis, Colitis, Ulcerative drug therapy, Crohn Disease diagnosis, Crohn Disease drug therapy, Inflammatory Bowel Diseases therapy
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Background & Aims: End points to determine the efficacy and safety of medical therapies for Crohn's disease (CD) and ulcerative colitis (UC) are evolving. Given the heterogeneity in current outcome measures, harmonizing end points in a core outcome set for randomized controlled trials is a priority for drug development in inflammatory bowel disease., Methods: Candidate outcome domains and outcome measures were generated from systematic literature reviews and patient engagement surveys and interviews. An iterative Delphi process was conducted to establish consensus: panelists anonymously voted on items using a 9-point Likert scale, and feedback was incorporated between rounds to refine statements. Consensus meetings were held to ratify the outcome domains and core outcome measures. Stakeholders were recruited internationally, and included gastroenterologists, colorectal surgeons, methodologists, and clinical trialists., Results: A total of 235 patients and 53 experts participated. Patient-reported outcomes, quality of life, endoscopy, biomarkers, and safety were considered core domains; histopathology was an additional domain for UC. In CD, there was consensus to use the 2-item patient-reported outcome (ie, abdominal pain and stool frequency), Crohn's Disease Activity Index, Simple Endoscopic Score for Crohn's Disease, C-reactive protein, fecal calprotectin, and co-primary end points of symptomatic remission and endoscopic response. In UC, there was consensus to use the 9-point Mayo Clinic Score, fecal urgency, Robarts Histopathology Index or Geboes Score, fecal calprotectin, and a composite primary end point including both symptomatic and endoscopic remission. Safety outcomes should be reported using the Medical Dictionary for Regulatory Activities., Conclusions: This multidisciplinary collaboration involving patients and clinical experts has produced the first core outcome set that can be applied to randomized controlled trials of CD and UC., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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- 2022
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16. Appropriateness of Medical and Surgical Treatments for Chronic Pouchitis Using RAND/UCLA Appropriateness Methodology.
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Syal G, Sparrow MP, Velayos F, Cheifetz AS, Devlin S, Irving PM, Kaplan GG, Raffals LE, Ullman T, Gecse KB, Fleshner PR, Lightner AL, Siegel CA, and Melmed GY
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- Anti-Bacterial Agents therapeutic use, Budesonide therapeutic use, Humans, Biological Products therapeutic use, Crohn Disease drug therapy, Graft vs Host Disease, Ileitis etiology, Pouchitis diagnosis, Pouchitis drug therapy
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Background and Aims: The treatment of chronic pouchitis remains a challenge due to the paucity of high-quality studies. We aimed to provide guidance for clinicians on the appropriateness of medical and surgical treatments in chronic pouchitis., Methods: Appropriateness of medical and surgical treatments in patients with chronic pouchitis was considered in 16 scenarios incorporating presence/absence of four variables: pouchitis symptoms, response to antibiotics, significant prepouch ileitis, and Crohn's disease (CD)-like complications (i.e., stricture or fistula). Appropriateness of permanent ileostomy in patients refractory to medical treatments was considered in eight additional scenarios. Using the RAND/UCLA appropriateness method, international IBD expert panelists rated appropriateness of treatments in each scenario on a 1-9 scale., Results: Chronic antibiotic therapy was rated appropriate only in asymptomatic antibiotic-dependent patients with no CD-like complications and inappropriate in all other scenarios. Ileal-release budesonide was rated appropriate in 6/16 scenarios including patients with significant prepouch ileitis but no CD-like complications. Probiotics were considered either inappropriate (14/16) or uncertain (2/16). Biologic therapy was considered appropriate in most scenarios (14/16) and uncertain in situations where significant prepouch ileitis or CD-like complications were absent (2/16). In patients who are refractory to all medications, permanent ileostomy was considered appropriate in all scenarios (7/8) except in asymptomatic patients with no CD-like complications., Conclusions: In the presence of significant prepouch ileitis or CD-like complications, chronic antibiotics and probiotics are inappropriate. Biologics are appropriate in all patients except in asymptomatic patients with no evidence of complications. Permanent ileostomy is appropriate in most medically refractory patients., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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17. A Single-Center Experience of Transanal Proctectomy With IPAA for IBD.
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Truong A, Wood T, Fleshner PR, and Zaghiyan KN
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- Anastomotic Leak epidemiology, Anastomotic Leak etiology, Humans, Postoperative Complications epidemiology, Retrospective Studies, Colitis, Ulcerative surgery, Crohn Disease surgery, Proctectomy adverse effects, Proctectomy methods
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Background: Restorative proctocolectomy with IPAA is the standard procedure in ulcerative colitis patients with medical refractory disease or dysplasia and select patients with IBD unclassified or Crohn's disease. A variety of minimally invasive techniques have become increasingly utilized, including the transanal IPAA. Unfortunately, despite its growing popularity, there is a lack of high-quality data for the transanal approach., Objective: The aim of this study was to investigate clinical outcomes, including complication rates, during our initial experience with the transanal approach., Design: The study design was a single-center prospective case series., Settings: The study was conducted at a tertiary referral center., Patients: The study included patients with ulcerative colitis, IBD unclassified, and Crohn's disease undergoing 2- or 3-stage restorative proctocolectomy with IPAA., Interventions: Consecutive patients after November 2016 undergoing restorative proctocolectomy with transanal approach were compared with a historic cohort of patients who underwent an open approach before October 2016., Main Outcome Measures: The primary outcome measure was early and late anastomotic leak rates during our learning curve. Secondary outcomes included postoperative clinical measures., Results: The study group consisted of 100 open and 65 transanal approach patients. Median (interquartile range) estimated blood loss was lower with the transanal approach (100 [50-150] vs 150 [100-250] mL; p = 0.007), and hospital stay was lower in the transanal group by 2 days ( p < 0.001). There was a significantly higher rate of anastomotic leaks with the transanal approach compared with the open approach (n = 7 [11%] vs n = 2 [2%] respectively; p = 0.03). There were fewer, but statistically insignificant, anastomotic complications in the third tertile, which was later in our learning curve., Limitations: The study was nonrandomized with consecutive assignment, introducing possible selection and chronology biases., Conclusion: Restorative proctocolectomy with the transanal approach was associated with lower blood loss and shorter hospital stay but a significantly higher anastomotic leak rate. The transanal minimally invasive approach for pouch surgery offers some advantages but carries a steep learning curve. See Video Abstract at http://links.lww.com/DCR/B842 ., Experiencia De Un Solo Centro De Proctectoma Transanal Con Anastomosis Ileoanal Con Reservorio Ileal Para Enfermedad Inflamatoria Intestinal: ANTECEDENTES:La proctocolectomía restaurativa con anastomosis ileoanal con reservorio ileal es el procedimiento estándar en pacientes con colitis ulcerativa con enfermedad médica refractaria o displasia y pacientes seleccionados con enfermedad inflamatoria intestinal no clasificada o enfermedad de Crohn. Se ha utilizado cada vez más una variedad de técnicas mínimamente invasivas, incluido el enfoque de anastomosis ileoanal con reservorio ileal transanal. Desafortunadamente, a pesar de su creciente popularidad, hay falta de datos de alta calidad para el enfoque transanal.OBJETIVO:Investigar los resultados clínicos, incluidas las tasas de complicaciones, durante nuestra experiencia inicial con el enfoque transanal.DISEÑO:Serie de casos prospectivos de un solo centro.AJUSTES:Centro de referencia terciario.PACIENTES:Pacientes con ulcerativa, enfermedad inflamatoria intestinal no clasificada y enfermedad de Crohn sometidos a proctocolectomía restaurativa de 2 o 3 etapas con anastomosis ileoanal con reservorio ileal.INTERVENCIONES:Pacientes consecutivos después de noviembre del 2016 sometidos a proctocolectomía restaurativa con abordaje transanal fueron comparados con una cohorte histórica que se sometieron a un abordaje abierto antes de octubre del 2016.PRINCIPALES MEDIDAS DE RESULTADO:La principal medida de resultado fueron las tasas de fuga anastomótica temprana y tardía durante nuestra curva de aprendizaje. Los resultados secundarios incluyeron medidas clínicas postoperatorias.RESULTADOS:El grupo de estudio estuvo formado por 100 pacientes con abordaje abierto y 65 por vía transanal. La media de pérdida sanguínea estimada fue menor con el abordaje transanal (100 [50-150] vs 150 [100-250] mL; p = 0.007) y la estancia hospitalaria fue menor en el grupo transanal por 2 días ( p < 0.001). Hubo una tasa significativamente mayor de fugas anastomóticas con el abordaje transanal en comparación con el abordaje abierto (n = 7 [11%] vs n = 2 [2%] respectivamente, p = 0.03). Hubo menos complicaciones anastomóticas, pero estadísticamente insignificantes, en el tercer tercil, posterior en nuestra curva de aprendizaje.LIMITACIONES:Estudio no randomizado con asignación consecutiva que presenta posibles sesgos de selección y cronología.CONCLUSIÓNES:La proctocolectomía restaurativa con abordaje transanal se asoció a una menor pérdida sanguínea y estancia hospitalaria más corta, pero con una tasa de fuga anastomótica significativamente mayor. El abordaje transanal mínimamente invasivo para cirugía de reservorio ofrece algunas ventajas, pero conlleva a una curva de aprendizaje pronunciada. Consulte Video Resumen en http://links.lww.com/DCR/B842 . (Traducción- Dr. Francisco M. Abarca-Rendon )., (Copyright © The ASCRS 2021.)
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- 2022
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18. Concise Commentary: Crystallomancy and Ileal Pouch Surgery.
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Fleshner PR
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- Anastomosis, Surgical, Humans, Colitis, Ulcerative surgery, Colonic Pouches, Proctocolectomy, Restorative adverse effects
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- 2022
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19. Is Intestinal Diversion an Effective Treatment for Distal Crohn's Disease?
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Lightner AL, Buhulaigah H, Zaghiyan K, Holubar SD, Steele SR, Jia X, McMichael J, Vaidya P, and Fleshner PR
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- Adult, Colectomy, Humans, Ileostomy, Retrospective Studies, Treatment Outcome, Crohn Disease complications
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Background: Fecal diversion with an ileostomy is selectively used in cases of medically refractory Crohn's proctocolitis or advanced perianal disease. The aim of this study was to evaluate clinical improvement after fecal diversion in Crohn's disease (CD) and factors associated with clinical improvement., Methods: A retrospective chart review of adult CD patients undergoing ileostomy formation for distal disease between 2000 and 2019 at 2 CD referral centers was conducted. The primary outcome was the rate of clinical improvement with diversion that allowed for successful restoration of intestinal continuity. Secondary outcomes included the rate of clinical and endoscopic improvement after fecal diversion, ileostomy morbidity, need for subsequent total proctocolectomy and end ileostomy, and factors associated with a clinical response to fecal diversion., Results: A total of 132 patients with a median age of 36 years (interquartile range, 25-49) were included. Mean duration of disease was 16.2 years (10.4) years. Indication for surgery was medically refractory proctocolitis with perianal disease (n = 59; 45%), perianal disease alone (n = 24; 18%), colitis (n = 37; 28%), proctitis (n = 4; 3%), proctocolitis alone (n = 4; 3%), and ileitis with perianal disease (n = 4; 3%). Medications used before surgery included corticosteroids (n = 59; 45%), immunomodulators (n = 55; 42%) and biologics (n = 82; 62%). The clinical and endoscopic response to diversion was 43.2% (n = 57) and 23.9% (n = 16). At a median follow-up of 35.3 months (interquartile range, 10.6-74.5), 25 patients (19%) had improved and had ileostomy reversal, but 86 (65%) did not improve, with 50 (38%) undergoing total proctocolectomy for persistent symptoms. There were no significant predictors of clinical improvement., Conclusions: The use of a "temporary" ileostomy is largely ineffective in achieving clinical response., (© 2021 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2022
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20. Therapeutic Drug Monitoring of Biologics in IBD: Essentials for the Surgical Patient.
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Nones RB, Fleshner PR, Queiroz NSF, Cheifetz AS, Spinelli A, Danese S, Peyrin-Biroulet L, Papamichael K, and Kotze PG
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Despite significant development in the pharmacological treatment of inflammatory bowel diseases (IBD) along with the evolution of therapeutic targets and treatment strategies, a significant subset of patients still requires surgery during the course of the disease. As IBD patients are frequently exposed to biologics at the time of abdominal and perianal surgery, it is crucial to identify any potential impact of biological agents in the perioperative period. Even though detectable serum concentrations of biologics do not seem to increase postoperative complications after abdominal procedures in IBD, there is increasing evidence on the role of therapeutic drug monitoring (TDM) in the perioperative setting. This review aims to provide a comprehensive summary of published studies reporting the association of drug concentrations and postoperative outcomes, postoperative recurrence (POR) after an ileocolonic resection for Crohn's disease (CD), colectomy rates in ulcerative colitis (UC), and perianal fistulizing CD outcomes in patients treated with biologics. Current data suggest that serum concentrations of biologics are not associated with an increased risk in postoperative complications following abdominal procedures in IBD. Moreover, higher concentrations of anti-TNF agents are associated with a reduction in colectomy rates in UC. Finally, higher serum drug concentrations are associated with reduced rates of POR after ileocolonic resections and increased rates of perianal fistula healing in CD. TDM is being increasingly used to guide clinical decision making with favorable outcomes in many clinical scenarios. However, given the lack of high quality data deriving mostly from retrospective studies, the evidence supporting the systematic application of TDM in the perioperative setting is still inconclusive.
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- 2021
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21. Preface: Introducing the Management of Postoperative Complications.
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Lightner AL and Fleshner PR
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- Adult, Child, Humans, Perioperative Care standards, Postoperative Complications diagnosis, Postoperative Complications prevention & control, Postoperative Complications therapy, Surgical Procedures, Operative adverse effects
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- 2021
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22. Postoperative complications and waiting time for surgical intervention after radiologically guided drainage of intra-abdominal abscess in patients with Crohn's disease.
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El-Hussuna A, Karer MLM, Uldall Nielsen NN, Mujukian A, Fleshner PR, Iesalnieks I, Horesh N, Kopylov U, Jacoby H, Al-Qaisi HM, Colombo F, Sampietro GM, Marino MV, Ellebæk M, Steenholdt C, Sørensen N, Celentano V, Ladwa N, Warusavitarne J, Pellino G, Zeb A, Di Candido F, Hurtado-Pardo L, Frasson M, Kunovsky L, Yalcinkaya A, Tatar OC, Alonso S, Pera M, Granero AG, Rodríguez CA, Minaya A, Spinelli A, and Qvist N
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- Adult, Aged, Drainage, Female, Humans, Retrospective Studies, Waiting Lists, Abdominal Abscess diagnostic imaging, Abdominal Abscess etiology, Abdominal Abscess surgery, Crohn Disease complications, Crohn Disease surgery
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Background: In patients with active Crohn's disease (CD), treatment of intra-abdominal abscess usually comprises antibiotics and radiologically guided percutaneous drainage (PD) preceding surgery. The aim of this study was to investigate the risk of postoperative complications and identify the optimal time interval for surgical intervention after PD., Methods: A multicentre, international, retrospective cohort study was carried out. Details of patients with diagnosis of CD who underwent ultrasonography- or CT-guided PD were retrieved from hospital records using international classification of disease (ICD-10) diagnosis code for CD combined with procedure code for PD. Clinical variables were retrieved and the following outcomes were measured: 30-day postoperative overall complications, intra-abdominal septic complications, unplanned intraoperative adverse events, surgical-site infections, sepsis and pathological postoperative ileus, in addition to abscess recurrence. Patients were categorized into three groups according to the length of the interval from PD to surgery (1-14 days, 15-30 days and more than 30 days) for comparison of outcomes., Results: The cohort comprised 335 CD patients with PD followed by surgery. Median age was 33 (i.q.r. 24-44) years, 152 (45.4 per cent) were females, and median disease duration was 9 (i.q.r. 3.6-15) years. Overall, the 30-day postoperative complications rate was 32.2 per cent and the mortality rate was 1.5 per cent. After adjustment for co-variables, older age (odds ratio 1.03 (95 per cent c.i. 1.01 to 1.06), P < 0.012), residual abscess after PD (odds ratio 0.374 (95 per cent c.i. 0.19 to 0.74), P < 0.014), smoking (odds ratio 1.89 (95 per cent c.i. 1.01 to 3.53), P = 0.049) and low serum albumin concentration (odds ratio 0.921 (95 per cent c.i. 0.89 to 0.96), P < 0.001) were associated with higher rates of postoperative complications. A short waiting interval, less than 2 weeks after PD, was associated with a high incidence of abscess recurrence (odds ratio 0.59 (95 per cent c.i. 0.36 to 0.96), P = 0.042)., Conclusion: Smoking, low serum albumin concentration and older age were significantly associated with postoperative complications. An interval of at least 2 weeks after successful PD correlated with reduced risk of abscess recurrence., (© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd.)
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- 2021
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23. Endoscopic evaluation after surgery in inflammatory bowel disease.
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Syal G, Fleshner PR, and Melmed GY
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- Endoscopy, Humans, Colitis, Crohn Disease, Inflammatory Bowel Diseases surgery
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- 2021
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24. Antitumour necrosis factor therapy is associated with de novo Crohn's disease after ileal pouch-anal anastomosis.
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Truong A, Zaghiyan KN, Mirocha J, Melmed GY, McGovern DPB, Syal G, Ha CY, Targan SR, and Fleshner PR
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- Aged, Anastomosis, Surgical adverse effects, Humans, Necrosis, Postoperative Complications, Prospective Studies, Colitis, Ulcerative drug therapy, Colitis, Ulcerative surgery, Colonic Pouches adverse effects, Crohn Disease drug therapy, Crohn Disease surgery, Proctocolectomy, Restorative adverse effects
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Aim: Tumour necrosis factor inhibitors (TNFi) have revolutionized the management of moderate to severe ulcerative colitis (UC) since their approval for UC in 2005. However, many patients ultimately require surgery with ileal pouch-anal anastomosis (IPAA). Development of de novo Crohn's disease (CD) following IPAA is an increasingly common and devastating complication, sometimes progressing to pouch failure. The aim of this study was to evaluate the association of preoperative TNFi exposure and the development of de novo CD after IPAA., Method: A prospective single-centre inflammatory bowel disease (IBD) registry was searched for consecutive patients with UC undergoing IPAA during a 25-year period ending July 2018. Patients with preoperative CD or IBD-unclassified were excluded. De novo CD was diagnosed upon endoscopic evidence of five or more mucosal ulcers proximal to the ileal pouch any time after surgery and/or pouch fistula occurring more than three months after ileostomy closure., Results: The study cohort consisted of 400 patients with a median follow-up of 44.0 (IQR 11-113) months. Sixty-two (16%) patients developed de novo CD 28.0 (IQR 6-67) months following ileostomy closure. Survival analysis of TNFi era patients revealed a significant increase in de novo CD risk in those with preoperative TNFi exposure. Multivariable proportional hazards modelling revealed two independent predictors for de novo CD development: older age was protective (HR 0.89 per 5-year increase; P = 0.009) and preoperative TNFi exposure was hazardous (HR 2.10; P = 0.011)., Conclusion: This prospective study is the first to suggest an association between preoperative TNFi exposure and the development of de novo CD., (© 2021 The Association of Coloproctology of Great Britain and Ireland.)
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- 2021
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25. Perioperative safety of tofacitinib in surgical ulcerative colitis patients.
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Lightner AL, Vaidya P, Holubar S, Warusavitarne J, Sahnan K, Carrano FM, Spinelli A, Zaghiyan K, and Fleshner PR
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- Adult, Humans, Male, Piperidines adverse effects, Postoperative Complications epidemiology, Pyrimidines, Retrospective Studies, Colitis, Ulcerative drug therapy, Colitis, Ulcerative surgery
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Aim: The literature regarding monoclonal antibodies and increased postoperative complications in inflammatory bowel disease remains controversial. There have been no studies investigating tofacitinib. The aim of this work was to determine preoperative exposure to the small-molecule inhibitor tofacitinib and postoperative outcomes., Method: We conducted a retrospective review of all adult patients exposed to tofacitinib within 4 weeks of total abdominal colectomy for medically refractory ulcerative colitis between 1 January 2018 and 1 September 2020 at four inflammatory bowel disease referral centres. Data collected included patient demographics and 90-day postoperative morbidity, readmission and reoperation rates., Results: Fifty-three patients (32 men, 60%) with ulcerative colitis underwent a total abdominal colectomy (n = 50 laparoscopic, 94%) for medically refractory disease. Previous exposure to monoclonal antibodies included infliximab (n = 34), adalimumab (n = 35), certolizumab pegol (n = 5), vedolizumab (n = 33) and ustekinumab (n = 10). Twenty-seven (51%) patients were on concurrent prednisone at a median daily dose of 30 mg by mouth (range 5-60 mg). There were no postoperative deaths. Ninety-day postoperative complications included ileus (n = 7, 13.2%), superficial surgical site infection (n = 4, 7.5%), intra-abdominal abscess (n = 2, 3.8%) and venous thromboembolism (VTE) (n = 7, 13.2%). Locations of VTE included portomesenteric venous thrombus (n = 4), internal iliac vein (n = 2) and pulmonary embolism (n = 1). Nine (17%) patients were readmitted to hospital and five (9%) patients had a reoperation., Conclusion: Mirroring the recently issued US Food and Drug Administration black box warning of an increased risk of VTE in medically treated ulcerative colitis patients taking tofacitinib, preoperative tofacitinib exposure may present an increased risk of postoperative VTE events. Consideration should be given for prolonged VTE prophylaxis on hospital discharge., (© 2021 The Association of Coloproctology of Great Britain and Ireland.)
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- 2021
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26. Transanal Ileal Pouch: Is It Better?
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Park L, Zaghiyan KN, and Fleshner PR
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- Anastomotic Leak surgery, Humans, Postoperative Complications epidemiology, Treatment Outcome, Colitis, Ulcerative surgery, Colonic Pouches, Proctocolectomy, Restorative
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Background: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the procedure of choice for patients with ulcerative colitis and select patients with Crohn's disease. Minimally invasive techniques have been increasingly adopted including the transanal approach. However there remains a dearth of comparative data assessing the technical advantages and outcomes of a transanal approach to the IPAA against other minimally invasive techniques. Methods: In this review, we describe our learned approach with the transanal IPAA (ta-IPAA) and highlight key technical steps for a successful surgery in addition to evaluating the current literature on surgical and functional outcomes of this relatively novel procedure. Results: The ta-IPAA affords better visualization and access during a pelvic dissection translating to lower conversion rates. Lower odds of postoperative morbidity have been reported, but there was no difference in severity of complications when present. Though this technique has the advantages of a more accurate rectal transection obviating the need for multiple staple firings, the risk of anastomotic leak was similar between the two groups. Functional outcomes were found to be overall similar, though data is limited. Conclusions: The technical aspects of the IPAA have continued to evolve to mitigate the challenges posed by a deep pelvic dissection. While the ta-IPAA has been shown to be a safe and feasible procedure, the true advantages and functional benefits of this technique have yet to be elucidated with large-scale, quality data.
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- 2021
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27. A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE Trial.
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Truong A, Fleshner PR, Mirocha JM, Tran HP, Shane R, and Zaghiyan KN
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- Abdominal Muscles innervation, Administration, Oral, Adult, Analgesics, Opioid therapeutic use, Colorectal Surgery standards, Colorectal Surgery statistics & numerical data, Combined Modality Therapy methods, Dexamethasone therapeutic use, Enhanced Recovery After Surgery, Epinephrine therapeutic use, Female, Humans, Intraoperative Care methods, Laparoscopy methods, Length of Stay statistics & numerical data, Liposomes pharmacology, Male, Middle Aged, Morphine administration & dosage, Prospective Studies, Surgeons, Abdominal Muscles drug effects, Anesthetics, Local administration & dosage, Bupivacaine administration & dosage, Liposomes administration & dosage, Nerve Block methods, Pain Management methods
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Background: Transversus abdominis plane blocks are increasingly used to achieve opioid-sparing analgesia after colorectal surgery. Traditionally, bupivacaine was the long-acting analgesic of choice, but the addition of dexamethasone and/or epinephrine to bupivacaine may extend block duration. Liposomal bupivacaine has also been suggested to achieve an extended analgesia duration of 72 hours but is significantly more expensive., Objective: The purpose of this study was to compare pain control between laparoscopic transversus abdominis plane blocks using liposomal bupivacaine versus bupivacaine with epinephrine and dexamethasone., Design: This was a parallel-group, single-institution, randomized clinical trial., Settings: The study was conducted at a single tertiary medical center., Patients: Consecutive patients between October 2018 to October 2019, ages 18 to 90 years, undergoing minimally invasive colorectal surgery with multimodal analgesia were included., Interventions: Patients were randomly assigned 1:1 to receive a laparoscopic transversus abdominis plane block with liposomal bupivacaine or bupivacaine with epinephrine and dexamethasone., Main Outcome Measures: The primary outcome was total oral morphine equivalents administered in the first 48 hours postoperatively. Secondary outcomes included pain scores, time to ambulation and solid diet, hospital length of stay, and complications., Results: A total of 102 patients (50 men) with a median age of 42 years (interquartile range, 29-60 y) consented and were randomly assigned. The primary end point, total oral morphine equivalents administered in the first 48 hours, was not significantly different between the liposomal bupivacaine group (median = 69 mg) and the bupivacaine with epinephrine and dexamethasone group (median = 47 mg; difference in medians = 22 mg, (95% CI, -17 to 49 mg); p = 0.60). There were no significant differences in pain scores, time to ambulation, time to diet tolerance, time to bowel movement, length of stay, overall complications, or readmission rate between groups. There were no treatment-related adverse outcomes., Limitations: This study was not placebo controlled or blinded., Conclusions: This first randomized trial comparing laparoscopic transversus abdominis plane block with liposomal bupivacaine or bupivacaine with epinephrine and dexamethasone showed that a liposomal bupivacaine block does not provide superior or extended analgesia in the era of standardized multimodal analgesia protocols.See Video Abstract at http://links.lww.com/DCR/B533., Estudio Prospectivo Y Randomizado De Bloqueo Del Plano Muscular Transverso Del Abdomen Realizado Por El Cirujano Con Bupivacana Versus Bupivacana Liposomal Estudio Tingle: ANTECEDENTES:El bloqueo anestésico del plano muscular transverso del abdomen se utiliza cada vez más para lograr una analgesia con menos consumo de opioides después de cirugía colorrectal. Tradicionalmente, la Bupivacaína era el analgésico de acción prolongada de elección, pero al agregarse Dexametasona y/o Adrenalina a la Bupivacaína se puede prolongar la duración del bloqueo. También se ha propuesto que la Bupivacaína liposomal logra una duración prolongada de la analgesia de 72 horas, pero es significativamente más cara.OBJETIVO:Comparar el control del dolor entre bloqueo laparoscópico del plano de los transversos del abdomen usando Bupivacaína liposomal versus Bupivacaína con Adrenalina y Dexametasona.DISEÑO:Estudio clínico prospectivo y randomizado de una sola institución en grupos paralelos.AJUSTE:Centro médico terciario único.PACIENTES:Todos aquellos pacientes entre 18 y 90 años sometidos a cirugía colorrectal mínimamente invasiva con analgesia multimodal, entre octubre de 2018 a octubre de 2019 incluidos de manera consecutiva.INTERVENCIONES:Los pacientes fueron seleccionados aleatoriamente 1:1 para recibir un bloqueo laparoscópico del plano de los transversos del abdomen con Bupivacaína liposomal o Bupivacaína con Adrenalina y Dexametasona.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el total de equivalentes de morfina oral administradas en las primeras 48 horas después de la operación. Los resultados secundarios incluyeron puntuaciones de dolor, inicio de dieta sólida, tiempo de inicio a la deambulación, la estadía hospitalaria y las complicaciones.RESULTADOS:Un total de 102 pacientes (50 hombres) con una mediana de edad de 42 años (IQR 29-60) fueron incluidos aleatoriamente. El criterio de valoración principal, equivalentes de morfina oral total administrada en las primeras 48 horas, no fue significativamente diferente entre el grupo de Bupivacaína liposomal (mediana = 69 mg) y el grupo de Bupivacaína con Adrenalina y Dexametasona (mediana = 47 mg; diferencia en medianas = 22 mg, IC del 95% [-17] - 49 mg, p = 0,60). No hubo diferencias significativas en las puntuaciones de dolor, tiempo de inicio a la deambulación, el tiempo de tolerancia a la dieta sólida, el tiempo hasta el primer evacuado intestinal, la duración de la estadía hospitalaria, las complicaciones generales o la tasa de readmisión entre los grupos. No hubo resultados adversos relacionados con el tratamiento.LIMITACIONES:Este estudio no fue controlado con placebo ni de manera cegada.CONCLUSIONES:Este primer estudio prospectivo y randomizado que comparó el bloqueo del plano de los músculos transversos del abdomen por vía laparoscópica, utilizando Bupivacaína liposomal o Bupivacaína con Adrenalina y Dexametasona, demostró que el bloqueo de Bupivacaína liposomal no proporciona ni mejor analgesia ni un efecto mas prolongado.Consulte Video Resumen en http://links.lww.com/DCR/B533., (Copyright © The ASCRS 2021.)
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- 2021
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28. Pre-pouch Ileitis is Associated with Development of Crohn's Disease-like Complications and Pouch Failure.
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Syal G, Shemtov R, Bonthala N, Vasiliauskas EA, Feldman EJ, Zaghiyan K, Ha CY, McGovern DPB, Targan SR, Melmed GY, and Fleshner PR
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- Adult, Constriction, Pathologic diagnosis, Constriction, Pathologic etiology, Constriction, Pathologic surgery, Disease-Free Survival, Female, Humans, Ileitis complications, Ileitis diagnosis, Male, Proctocolectomy, Restorative adverse effects, Proctocolectomy, Restorative methods, Reoperation methods, Reoperation statistics & numerical data, Risk Assessment, Risk Factors, Colitis, Ulcerative diagnosis, Colitis, Ulcerative drug therapy, Colitis, Ulcerative surgery, Colonic Pouches adverse effects, Crohn Disease diagnosis, Crohn Disease drug therapy, Crohn Disease surgery, Immunosuppressive Agents therapeutic use, Postoperative Complications diagnosis, Postoperative Complications surgery, Pouchitis etiology, Pouchitis therapy
- Abstract
Background and Aims: It is unclear whether pre-pouch ileitis heralds an aggressive inflammatory pouch disease in patients with ileal pouch-anal anastomosis [IPAA]. We compared outcomes of patients with pouchitis and concomitant pre-pouch ileitis with those with pouchitis alone., Methods: Patients undergoing IPAA surgery for inflammatory bowel disease, who subsequently developed pouchitis with concomitant pre-pouch ileitis [pre-pouch ileitis group], were matched by year of IPAA surgery and preoperative diagnosis [ulcerative colitis or inflammatory bowel disease-unclassified] with patients who developed pouchitis alone [pouchitis group]. Primary outcomes were development of Crohn's disease [CD]-like complications [non-anastomotic strictures or perianal disease >6 months after ileostomy closure] and pouch failure. Secondary outcomes were need for surgical/endoscopic interventions and immunosuppressive therapy. Log-rank testing was used to compare outcome-free survival, and Cox regression was performed to identify predictors of outcomes., Results: There were 66 patients in each group. CD-like complications and pouch failure developed in 36.4% and 7.6% patients in the pre-pouch ileitis group and 10.6% and 1.5% in pouchitis group, respectively. CD-like complications-free survival [log-rank p = 0.0002] and pouch failure-free survival [log-rank p = 0.046] were significantly lower in the pre-pouch ileitis group. The pre-pouch ileitis group had a higher risk of requiring surgical/endoscopic interventions [log-rank p = 0.0005] and immunosuppressive therapy [log-rank p <0.0001]. Pre-pouch ileitis was independently associated with an increased risk of CD-like complications (hazard ratio [HR] 3.8; p = 0.0007), need for surgical/endoscopic interventions [HR 4.1; p = 0.002], and immunosuppressive therapy [HR 5.0; p = 0.0002]., Conclusions: Pre-pouch ileitis is associated with a higher risk of complicated disease and pouch failure than pouchitis. It should be considered a feature of CD., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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29. IPAA in Known Preoperative Crohn's Disease: A Systematic Review.
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Lightner AL, Jia X, Zaghiyan K, and Fleshner PR
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- Adult, Anal Canal pathology, Colonic Pouches adverse effects, Constriction, Pathologic epidemiology, Crohn Disease diagnosis, Feasibility Studies, Fecal Incontinence epidemiology, Female, Fistula epidemiology, Follow-Up Studies, Humans, Intestinal Obstruction epidemiology, Male, Outcome Assessment, Health Care, Postoperative Complications epidemiology, Pouchitis epidemiology, Preoperative Period, Proctocolectomy, Restorative adverse effects, Proctocolectomy, Restorative psychology, Quality of Life, Sepsis epidemiology, Colitis, Ulcerative surgery, Colonic Pouches statistics & numerical data, Crohn Disease surgery, Equipment Failure statistics & numerical data, Proctocolectomy, Restorative instrumentation
- Abstract
Background: Crohn's disease is a relative contraindication to IPAA due to perceived increased rates of pouch failure., Objective: This study aimed to determine pouch functional outcomes and failure rates in patients with a known preoperative diagnosis of Crohn's disease., Data Sources: A database search was performed in Ovid Medline In-Process & Other NonIndexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, and Ovid Cochrane Database of Systematic Reviews., Study Selection: The published human studies that reported short-term postoperative outcomes and/or long-term outcomes following IPAA in adult (≥18 years of age) Crohn's disease populations were selected., Intervention: Ileal pouch anal anastomoses were constructed in patients who had Crohn's disease diagnosed preoperatively or through proctocolectomy pathology., Main Outcomes Measures: The primary outcomes measured were long-term functional outcomes (to maximal date of follow-up) and the pouch failure rate., Results: Of 7019 records reviewed, 6 full articles were included in the analysis. Rates of pelvic sepsis, small-bowel obstruction, pouchitis, anal stricture, and chronic sinus tract were 13%, 3%, 31%, 18%, and 28%. Rates of incontinence, urgency, pad usage in the day, pad usage at night, and need for antidiarrheals were 24%, 21%, 19%, 20%, and 28%, and mean 24-hour stool frequency was 6.3 bowel movements at a mean 69 months of follow-up. The overall pouch failure rate was 15%; no risk factors for pouch failure were identified., Limitations: This investigation was limited by the small number of studies with significant study heterogeneity., Conclusion: In patients with known preoperative Crohn's disease, IPAA construction is feasible with functional outcomes equivalent to patients with ulcerative colitis, but, even in highly selected patients with Crohn's disease, pouch failure rates remain higher than in patients with ulcerative colitis., (Copyright © The ASCRS 2020.)
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- 2021
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30. Fistulizing Crohn's disease.
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Lightner AL, Ashburn JH, Brar MS, Carvello M, Chandrasinghe P, van Overstraeten AB, Fleshner PR, Gallo G, Kotze PG, Holubar SD, Reza LM, Spinelli A, Strong SA, Tozer PJ, Truong A, Warusavitarne J, Yamamoto T, and Zaghiyan K
- Subjects
- Female, Humans, Proctocolectomy, Restorative adverse effects, Crohn Disease classification, Crohn Disease epidemiology, Crohn Disease physiopathology, Crohn Disease surgery, Intestinal Fistula diagnosis, Intestinal Fistula etiology, Intestinal Fistula physiopathology, Intestinal Fistula therapy
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- 2020
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31. Report From Advances in Inflammatory Bowel Diseases 2019: An Update.
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Lightner AL, Kotze PG, Ashburn JH, Remzi FH, Strong SA, and Fleshner PR
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- Congresses as Topic, Florida, Humans, Inflammatory Bowel Diseases therapy
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- 2020
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32. Excisional Hemorrhoidectomy: Safe in Patients With Crohn's Disease?
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Lightner AL, Kearney D, Giugliano D, Hull T, Holubar SD, Koh S, Zaghiyan K, and Fleshner PR
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- Adult, Aged, Contraindications, Procedure, Female, Hemorrhoidectomy methods, Hemorrhoids complications, Humans, Male, Middle Aged, Retrospective Studies, Risk Factors, Treatment Outcome, Young Adult, Crohn Disease complications, Hemorrhoidectomy adverse effects, Hemorrhoids surgery, Postoperative Complications etiology
- Abstract
Introduction: Due to concerns over wound healing, hemorrhoidectomy in patients with Crohn's disease (CD) remains controversial. We sought to ascertain safety and efficacy of excisional hemorrhoidectomy in CD., Methods: A retrospective review of all adult CD patients undergoing excisional hemorrhoidectomy between January 1, 1995, and January 1, 2019, at 2 IBD referral centers was performed. Data collected included patient demographics, clinical characteristics of CD (anorectal symptoms; prior nonoperative hemorrhoidal therapy; presence of other perianal disease; and activity, duration, and anatomic location of CD), and postoperative complications including bleeding, wound healing, and need for further therapy or surgical intervention after surgery., Results: A total of 36 adult patients with Crohn's disease with symptomatic hemorrhoidal disease were included. The study cohort included 16 males (44%), and median age was 49 (range, 21 to 77) years. Predominant symptoms included pain (n = 16; 44%), prolapse (n = 8; 22%), and bleeding (n = 12; 33%). Sixteen patients (44%) had nonoperative therapy before surgery. Twenty-four patients (67%) had other perianal disease. At the time of hemorrhoidectomy, 9 patients (25%) were exposed to corticosteroids, 8 patients (25%) to immunomodulators, and 9 patients (25%) to biologics. During a median follow-up time of 31.5 (range, 1 to 255) months after hemorrhoidectomy, 4 patients (11%) had complications (1 developed a stricture, 1 developed a perianal abscess/fistula, 1 had a nonhealing wound, and 1 had hemorrhoidal recurrence)., Conclusion: Our data suggest that excisional hemorrhoidectomy may be performed safely in CD patients who have failed nonoperative hemorrhoidal therapy without concern for de novo perianal disease or need for proctectomy.Hemorrhoidal disease is common in patients with Crohn's disease. This study sought to understand the outcomes of surgically treating hemorrhoids in patients with Crohn's disease., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2020
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33. Report From Advances in Inflammatory Bowel Diseases 2018: An Update.
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Lightner AL, Ashburn JH, Fleshner PR, Gustavo Kotze P, Remzi FH, and Strong SA
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- Humans, Inflammatory Bowel Diseases diagnosis, Inflammatory Bowel Diseases etiology, Inflammatory Bowel Diseases therapy
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- 2019
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34. Martius Flap for Persistent, Complex Rectovaginal Fistula.
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Kamiński JP, Tat C, Fleshner PR, and Zaghiyan K
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- Female, Humans, Plastic Surgery Procedures methods, Rectovaginal Fistula surgery, Surgical Flaps
- Published
- 2018
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35. A randomized, blinded, multicenter trial of a gentamicin vancomycin gel (DFA-02) in patients undergoing abdominal surgery.
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Bennett-Guerrero E, Berry SM, Bergese SD, Fleshner PR, Minkowitz HS, Segura-Vasi AM, Itani KMF, Henderson KW, Rackowski FP, Aberle LH, Stryjewski ME, Corey GR, and Allenby KS
- Subjects
- Adult, Aged, Double-Blind Method, Female, Gels, Humans, Incidence, Male, Middle Aged, Single-Blind Method, Surgical Wound Infection epidemiology, Treatment Outcome, Abdominal Wound Closure Techniques, Anti-Bacterial Agents therapeutic use, Digestive System Surgical Procedures adverse effects, Gentamicins therapeutic use, Surgical Wound Infection prevention & control, Vancomycin therapeutic use
- Abstract
Background: SI is a significant medical problem. DFA-02 is an investigational bioresorbable modified release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL). A Phase 2a study, where the drug was applied during surgical incision closure, suggested safety and tolerability but was not designed to assess its efficacy., Study Design: In a Phase 2b randomized, blinded trial patients undergoing abdominal, primarily colorectal, surgery were randomized (4:1:1) to one of three study arms: DFA-02, matching placebo gel, or standard of care (SOC) involving irrigation of the wound with normal saline. The DFA-02 and placebo gel groups received up to 20 mL of study drug inserted above the fascia during wound closure, and were treated in a double-blind manner; the SOC group was treated in a single-blind manner. The primary endpoint was SSI (adjudicated centrally by a blinded committee) through postoperative day 30., Results: Overall, 445 subjects (intention-to-treat) were randomized at 35 centers with 425 subjects completing the study and being evaluable. There were 67 SSIs (15.8%): 64.2% superficial, 7.5% deep, and 28.4% organ space. The incidence of SSI was not statistically significantly different between the DFA-02 and the placebo gel/SOC arms combined, 42/287 = 14.6% vs 25/138 = 18.1% (p = 0.36), respectively. Rehospitalization within 30 days was also similar between study groups (DFA-02 28.6%, placebo gel 21.4%, SOC 27.3%)., Conclusion: In this multicenter, blinded, randomized trial with central adjudication, the gentamicin/vancomycin gel was not associated with a significant reduction in SSI., Summary: Patients undergoing abdominal surgery were randomized to one of three study arms: DFA-02 gel consisting of both gentamicin and vancomycin, matching placebo gel, or standard of care (SOC). Of 425 patients completing the study at 35 sites the gentamicin/vancomycin gel was not associated with a significant reduction in SSI., (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Published
- 2017
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36. Current management of perianal Crohn's disease.
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Mahmoud NN, Halwani Y, Montbrun S, Shah PM, Hedrick TL, Rashid F, Schwartz DA, Dalal RL, Kamiński JP, Zaghiyan K, Fleshner PR, Weissler JM, and Fischer JP
- Subjects
- Abscess etiology, Abscess therapy, Anesthetics, Local therapeutic use, Anus Diseases etiology, Crohn Disease complications, Dietary Fiber, Female, Guidelines as Topic, Hemorrhoidectomy, Humans, Rectal Fistula etiology, Sphincterotomy, Endoscopic, Anus Diseases therapy, Crohn Disease therapy, Fissure in Ano therapy, Hemorrhoids therapy, Rectal Fistula therapy, Vaginal Fistula therapy
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- 2017
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37. Clinical Factors Associated with the Development of Crohn's Disease in Inflammatory Bowel Disease-unclassified Patients Undergoing Ileal Pouch-anal Anastomosis.
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Koh SZ, Zaghiyan KN, Li Q, Rabizadeh S, Melmed GY, Targan SR, and Fleshner PR
- Subjects
- Adolescent, Adult, Age of Onset, Crohn Disease diagnostic imaging, Disease Progression, Endoscopy, Female, Follow-Up Studies, Humans, Inflammatory Bowel Diseases pathology, Inflammatory Bowel Diseases surgery, Male, Middle Aged, Proctocolectomy, Restorative, Risk Factors, Young Adult, Crohn Disease epidemiology, Digestive System Fistula epidemiology
- Abstract
Background: Patients with inflammatory bowel disease-unclassified (IBDU) undergoing ileal pouch-anal anastomosis (IPAA) are at the risk of developing Crohn's disease (CD) after surgical procedure. In these patients, a clinically centered set of preoperative risk factors has not been prospectively defined. We report a single-center analysis of clinical factors associated with the development of CD after IPAA., Methods: Consecutive IBDU patients undergoing IPAA were identified. The diagnosis of IBDU was based on the presence of atypical disease distribution, presence of granulomas on endoscopic biopsy, and/or perianal disease. The diagnosis of CD after IPAA included the presence of afferent limb inflammation on pouchoscopy in the absence of nonsteroidal anti-inflammatory drug use and/or the development of pouch fistulizing disease more than 3 months after ileostomy closure., Results: Of the 149 study patients, 33 (22%) were diagnosed with CD after IPAA at a median of 37 months (interquartile range, 11-83 mo) after ileostomy closure. CD was diagnosed by mucosal inflammation above the pouch (n = 23; 70%), pouch fistulizing disease (n = 4; 12%), anorectal septic complications (n = 2; 6%), or the presence of ≥2 of the above complications (n = 4; 12%). The sole clinical predictor for the development of CD after IPAA was younger age at disease onset even after controlling for relevant clinical factors in a multivariate analysis. The odds of developing CD increased by 4% for each year that IBDU was diagnosed at a younger age., Conclusions: Younger age at disease onset is the only clinical factor associated with the development of CD after IPAA for IBDU. Patients with IBDU undergoing IPAA with young age at disease onset should be counseled about the potentially higher risk of developing CD.
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- 2016
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38. Colectomy with Permanent End Ileostomy Is More Cost-Effective than Ileal Pouch-Anal Anastomosis for Crohn's Colitis.
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Taleban S, Van Oijen MG, Vasiliauskas EA, Fleshner PR, Shen B, Ippoliti AF, Targan SR, and Melmed GY
- Subjects
- Adult, Anastomosis, Surgical economics, Anti-Inflammatory Agents economics, Anti-Inflammatory Agents therapeutic use, Colectomy economics, Cost-Benefit Analysis, Gastrointestinal Agents economics, Gastrointestinal Agents therapeutic use, Humans, Ileostomy economics, Male, Anal Canal surgery, Anastomosis, Surgical methods, Colectomy methods, Colonic Pouches, Crohn Disease surgery, Ileostomy methods
- Abstract
Background: Much of the economic burden of Crohn's disease (CD) is related to surgery. Twenty percent of patients with CD have isolated colonic disease. While permanent end ileostomy (EI) is generally the procedure of choice for patients with refractory CD colitis, single-center experiences suggest that restorative proctocolectomy (IPAA) is durable in select patients., Aims: We assessed the cost-effectiveness of total colectomy with permanent EI versus IPAA in medically refractory colonic CD., Methods: We used a lifetime Markov model with 6-month cycles to simulate quality-adjusted life years (QALYs) and cost. In each of the EI and IPAA strategies, patients could transition between multiple health states. One-way and multivariable sensitivity analysis and tornado analysis were performed to identify thresholds for factors influencing cost-effectiveness., Results: IPAA was more effective than EI surgery with an incremental cost-effectiveness ratio of $70,715 per QALY gained. We identified the following variables of importance in our model: (1) the cost of the EI surgery, (2) the cost of infliximab, and (3) the cost of gastroenterology ambulatory visit and labs. Threshold analysis revealed that if the costs associated with EI surgery exceeded $20,167 or if the utility of IPAA with CD remission without medical therapy exceeded 0.37, IPAA became the more cost-effective strategy., Conclusions: In patients with medically refractory CD isolated to the colon, colectomy with permanent EI is more cost-effective than IPAA unless the costs associated with the EI surgery exceed $20,167 or if the utility associated with IPAA and CD remission exceeds 0.37.
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- 2016
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39. A prospective evaluation of the ligation of the intersphincteric tract procedure for complex anal fistula in patients with Crohn's disease.
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Gingold DS, Murrell ZA, and Fleshner PR
- Subjects
- Adult, Crohn Disease surgery, Female, Follow-Up Studies, Humans, Ligation methods, Male, Prospective Studies, Quality of Life, Plastic Surgery Procedures, Rectal Fistula diagnosis, Rectal Fistula etiology, Time Factors, Treatment Outcome, Anal Canal surgery, Crohn Disease complications, Digestive System Surgical Procedures methods, Rectal Fistula surgery, Surgical Flaps
- Abstract
Objective: To evaluate 2- and 12-month outcomes after ligation of the intersphincteric fistula tract (LIFT) in Crohn's disease (CD)., Background: Surgical approaches to perianal fistulas in CD are frequently ineffective and hampered by concerns over adequate wound healing and sphincter injury. The efficacy of LIFT in CD patients is unknown., Methods: Consecutive cases of CD patients with transsphincteric fistulas were prospectively analyzed. Fistula healing and 2 validated quality-of-life indices were assessed., Results: Fifteen CD patients (9 women; mean age = 34.8 years) were identified. Location of the fistula was lateral (n = 10; 67%) or midline (n = 5; 33%). LIFT site healing was seen in 9 patients (60%) at 2-month follow-up. No patient developed fecal incontinence. LIFT site healing was seen in 8 of the 12 patients (67%) with complete 12-month follow-up. Significant factors for long-term LIFT site healing were lateral versus midline location (P = 0.02) and longer mean fistula length (P = 0.02). Patients who had successful operations significantly improved both their mean Wexner Perianal Crohn's Disease Activity Index and McMaster Perianal Crohn's Disease Activity Index quality-of-life scores at 2-month follow-up (14.0-3.8, P = 0.001, and 10.4-1.8, P = 0.0001, respectively)., Conclusions: CD-associated anal fistulas may be treated with LIFT. This surgical procedure is a safe, outpatient procedure that minimizes both perianal wound creation and sphincter injury.
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- 2014
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40. High-dose perioperative corticosteroids in steroid-treated patients undergoing major colorectal surgery: necessary or overkill?
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Zaghiyan KN, Murrell Z, Melmed GY, and Fleshner PR
- Subjects
- Adolescent, Adrenal Insufficiency etiology, Adrenal Insufficiency prevention & control, Adult, Aged, Blood Pressure, Drug Administration Schedule, Female, Heart Rate, Humans, Incidence, Inflammatory Bowel Diseases drug therapy, Male, Medical Records, Middle Aged, Retrospective Studies, Shock etiology, Treatment Outcome, Adrenal Cortex Hormones administration & dosage, Adrenal Insufficiency complications, Digestive System Surgical Procedures adverse effects, Perioperative Care methods, Shock prevention & control
- Abstract
Background: Steroid-treated patients undergoing major colorectal surgery are routinely treated with high-dose steroids (HDS) to prevent perioperative adrenal insufficiency and cardiovascular collapse. However, there is no evidence to support this practice., Methods: A retrospective analysis of 97 consecutive steroid-treated patients with inflammatory bowel disease who underwent major colorectal surgery was performed. The incidence of hemodynamic instability and surgical outcomes were compared in patients treated with perioperative low-dose steroids (LDS) versus HDS., Results: Forty-three patients were treated with HDS, and 54 patients received LDS. There was no significant difference in hemodynamic instability between HDS-treated (74%) and LDS-treated (78%) patients. No patients required rescue HDS for adrenal insufficiency., Conclusions: Steroid-treated patients with inflammatory bowel disease undergoing major colorectal surgery appear to have no clinically significant hemodynamic instability when managed with LDS versus HDS. A prospective study assessing perioperative steroid dosing in patients with inflammatory bowel disease is in progress., (Published by Elsevier Inc.)
- Published
- 2012
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41. Colorectal cancer screening and surveillance in Crohn's colitis.
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Basseri RJ, Basseri B, Vassilaki ME, Melmed GY, Ippoliti A, Vasiliauskas EA, Fleshner PR, Lechago J, Hu B, Berel D, Targan SR, and Papadakis KA
- Subjects
- Adolescent, Adult, Age Factors, Age of Onset, Anus Neoplasms complications, Anus Neoplasms diagnosis, Anus Neoplasms prevention & control, Colonoscopy, Colorectal Neoplasms diagnosis, Colorectal Neoplasms prevention & control, Early Detection of Cancer, Female, Humans, Male, Rectal Neoplasms complications, Rectal Neoplasms diagnosis, Rectal Neoplasms prevention & control, Risk Factors, Young Adult, Colorectal Neoplasms complications, Crohn Disease complications
- Abstract
Aims: To assess colonoscopic screening and surveillance for detecting neoplasia in patients with long-standing colonic Crohn's disease (CD)., Patients and Methods: Colonoscopy and biopsy records from patients with colonic CD were evaluated at the Cedars-Sinai Inflammatory Bowel Disease Center during a 17-year period (1992-2009)., Results: Overall, 904 screening and surveillance examinations were performed on 411 patients with Crohn's colitis (mean 2.2 examinations per patient). The screening and surveillance examinations detected neoplasia in 5.6% of the patient population; 2.7% had low-grade dysplasia (LGD) (n=11), 0.7% had high-grade dysplasia (HGD) (n=3), and 2.2% had carcinoma (anal carcinoma n=3; rectal carcinoma n=6). Mean age of CD diagnosis was 25.6±0.8 years in those with normal examinations, compared to 17.7±2.7 years (p<0.001) in those with HGD, 36.85±1.43 in those with LGD (p=0.021) and 28.32±3.24 years in those with any dysplasia/cancer (p=0.034). Disease duration in patients with normal examinations was 19.1±0.5 years, compared to 36.8±4.4 years (p<0.001) in HGD, 16.88±2.59 in those with LGD (p=0.253) and 30.68±4.03 years in those with any dysplasia/cancer (p=0.152). The mean interval between examinations was higher in HGD (31.5±9.4 months) compared to those with normal colonoscopies (12.92±1.250 months; p=0.002)., Conclusions: We detected cancer or dysplasia in 5.6% of patients with long-standing Crohn's colitis enrolled in a screening and surveillance program. Younger age at diagnosis of CD, longer disease course, and greater interval between exams were risk factors for the development of dysplasia., (Copyright © 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)
- Published
- 2012
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42. Interactions between commensal fungi and the C-type lectin receptor Dectin-1 influence colitis.
- Author
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Iliev ID, Funari VA, Taylor KD, Nguyen Q, Reyes CN, Strom SP, Brown J, Becker CA, Fleshner PR, Dubinsky M, Rotter JI, Wang HL, McGovern DP, Brown GD, and Underhill DM
- Subjects
- Animals, Antibodies, Fungal blood, Candida tropicalis immunology, Candida tropicalis isolation & purification, Candida tropicalis pathogenicity, Candida tropicalis physiology, Colitis, Ulcerative chemically induced, Colon immunology, Colony Count, Microbial, Dextran Sulfate, Disease Susceptibility, Female, Fungi classification, Fungi isolation & purification, Haplotypes, Humans, Immunity, Innate, Immunity, Mucosal, Intestinal Mucosa immunology, Intestines immunology, Intestines microbiology, Lectins, C-Type deficiency, Metagenome, Mice, Mice, Inbred C57BL, Polymorphism, Single Nucleotide, Colitis, Ulcerative immunology, Colitis, Ulcerative microbiology, Colon microbiology, Fungi immunology, Fungi physiology, Intestinal Mucosa microbiology, Lectins, C-Type genetics, Lectins, C-Type metabolism
- Abstract
The intestinal microflora, typically equated with bacteria, influences diseases such as obesity and inflammatory bowel disease. Here, we show that the mammalian gut contains a rich fungal community that interacts with the immune system through the innate immune receptor Dectin-1. Mice lacking Dectin-1 exhibited increased susceptibility to chemically induced colitis, which was the result of altered responses to indigenous fungi. In humans, we identified a polymorphism in the gene for Dectin-1 (CLEC7A) that is strongly linked to a severe form of ulcerative colitis. Together, our findings reveal a eukaryotic fungal community in the gut (the "mycobiome") that coexists with bacteria and substantially expands the repertoire of organisms interacting with the intestinal immune system to influence health and disease.
- Published
- 2012
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43. Scarless single-incision laparoscopic loop ileostomy: a novel technique.
- Author
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Zaghiyan KN, Murrell Z, and Fleshner PR
- Subjects
- Adult, Aged, Aged, 80 and over, Blood Loss, Surgical statistics & numerical data, Cicatrix prevention & control, Female, Humans, Length of Stay statistics & numerical data, Male, Middle Aged, Postoperative Complications epidemiology, Recovery of Function, Retrospective Studies, Treatment Outcome, Crohn Disease surgery, Ileostomy methods, Laparoscopy methods, Rectal Fistula surgery
- Abstract
Background: Laparoscopic surgery has become a favorable alternative to conventional open surgery for the creation of intestinal stomas, and it offers many benefits including reduced postoperative pain, ileus, and hospital stay. Single-incision laparoscopic surgery has been described for many abdominal operations. It may offer better cosmetic outcomes and reduce incisional pain, adhesions, and recovery time., Objective: In this study, we aimed to describe a novel technique of scarless single-incision laparoscopic loop ileostomy for fecal diversion and to report our experience with 8 patients who underwent this procedure within a 1-year period., Design: This study was designed as a retrospective case series., Settings: This investigation was conducted at a single-institution, tertiary referral center., Patients: Eight consecutive patients undergoing scarless single-incision laparoscopic loop ileostomy between August 2009 and August 2010 were included., Intervention: Scarless single-incision laparoscopic loop ileostomies were performed., Main Outcome Measures: Among the outcomes measured were operation time, intraoperative blood loss, recovery of intestinal function, length of hospital stay, and surgical complications., Results: Seven patients underwent surgery for active Crohn's disease refractory to medical therapy. One patient underwent surgery for radiation-induced rectovesical fistula. Median surgery time was 76 minutes, and median intraoperative blood loss was 10 mL. Median length of postoperative hospitalization was 7 days. Of the 8 patients included in our series, 2 patients (25%) required reoperation for stoma ischemia because of vascular congestion that we attribute to a tight fascial opening or extensive bowel manipulation. Other surgical complications included nonoperative readmission for ileus and partial small-bowel obstruction (n = 2), anal dilation to evacuate an obstructed distal colon (n = 1), and peristomal cellulitis (n = 1)., Limitations: This study was limited by its small sample size and its retrospective nature., Conclusion: Scarless single-incision laparoscopic loop ileostomy is a feasible alternative to standard laparoscopy for fecal diversion. Surgeons attempting this technique should do so with caution, given the high stoma ischemia rate in our small case series.
- Published
- 2011
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44. Variants in ZNF365 isoform D are associated with Crohn's disease.
- Author
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Haritunians T, Jones MR, McGovern DP, Shih DQ, Barrett RJ, Derkowski C, Dubinsky MC, Dutridge D, Fleshner PR, Ippoliti A, King L, Leshinsky-Silver E, Levine A, Melmed GY, Mengesha E, Vasilauskas EA, Ziaee S, Rotter JI, Targan SR, and Taylor KD
- Subjects
- Alleles, B-Lymphocytes immunology, B-Lymphocytes pathology, Biopsy, Cell Line, Crohn Disease metabolism, Crohn Disease pathology, DNA-Binding Proteins metabolism, Genetic Predisposition to Disease, Genome-Wide Association Study, Genotype, Humans, Intestinal Mucosa metabolism, Intestines pathology, Polymorphism, Single Nucleotide, Reverse Transcriptase Polymerase Chain Reaction, Transcription Factors metabolism, Zinc Fingers, Crohn Disease genetics, DNA-Binding Proteins genetics, Genomic Structural Variation, RNA genetics, Transcription Factors genetics
- Abstract
Objective: Genome-wide association studies have identified multiple Crohn's disease (CD) susceptibility loci, including association with non-coding intergenic single-nucleotide polymorphisms (SNPs) at 10q21., Design: To fine-map the 10q21 locus, the authors genotyped 86 SNPs in 1632 CD cases and 961 controls and performed single-marker and conditional analyses using logistic regression., Results: Association with CD risk spanning 11 SNPs (p<0.001) was observed. The most significant association observed was at the non-synonymous SNP, rs7076156 (Ala62Thr), in ZNF365. The alanine allele was over-represented in CD (p=5.23×10⁻⁷; OR=1.39 (95% CI 1.22 to 1.58)); allele frequency of 76% in CD and 69.7% in controls). Conditional analysis on rs7076156 nullified all other significant associations, suggesting that this is the causative variant at this locus. Four isoforms of ZNF365 have previously been identified, and rs7076156 is located in an exon unique to ZNF365 isoform D. The authors demonstrated, using reverse transcription-PCR, expression of ZNF365D in intestinal resections from both CD subjects and controls. Markedly reduced mean expression levels of ZNF365D were identified in Epstein-Barr virus-transformed lymphoblastoid cell lines from CD subjects homozygous for the risk allele (Ala). A whole-genome microarray expression study further suggested that the Ala62Thr change in ZNF365 isoform D is related to differential expression of the genes ARL4A, MKKS, RRAGD, SUMF2, TDR1 and ZNF148 in CD., Conclusions: Collectively, these data support the hypothesis that the non-synonymous Ala62Thr SNP, rs7076156, underlies the association between 10q21 and CD risk and suggest that this SNP acts by altering expression of genes under the control of ZNF365 isoform D.
- Published
- 2011
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45. Does prophylactic subcutaneous heparin increase the risk of wound infection after colorectal surgery?
- Author
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Milanchi S, Nasseri Y, Westhout F, Murrell ZA, and Fleshner PR
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Digestive System Surgical Procedures, Female, Heparin, Low-Molecular-Weight administration & dosage, Humans, Male, Middle Aged, Risk Factors, Venous Thromboembolism prevention & control, Young Adult, Anticoagulants administration & dosage, Heparin administration & dosage, Surgical Wound Infection epidemiology
- Abstract
Chemical prophylaxis using unfractionated heparin (UH) and low-molecular weight heparin is used in surgical patients to prevent venous thromboembolism. There is some evidence that prophylactic doses of heparin may increase the rate of surgical site infection (SSI) after elective orthopedic procedures. Little is known regarding the effect of heparin on SSI after colorectal procedures. We performed this study to study the effect of prophylactic unfractionated heparin on the rate of SSI after colorectal procedures. We did a retrospective analysis of 155 consecutive cases of patients of a single colorectal surgeon who underwent colorectal resection. Subcutaneous unfractionated heparin was given to 52 patients (29%). The rate of SSI in the group that received UH was 33 per cent versus 28 per cent in the group that did not receive UH (P = 0.31). There was also no significant effect of prophylactic heparin on SSI noted among any patient subgroup. The use of prophylactic unfractionated heparin after colorectal procedures does not seem to increase the rate of surgical site infection.
- Published
- 2010
46. Genetic predictors of medically refractory ulcerative colitis.
- Author
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Haritunians T, Taylor KD, Targan SR, Dubinsky M, Ippoliti A, Kwon S, Guo X, Melmed GY, Berel D, Mengesha E, Psaty BM, Glazer NL, Vasiliauskas EA, Rotter JI, Fleshner PR, and McGovern DP
- Subjects
- Acute Disease, Adolescent, Adult, Cohort Studies, Colectomy, Colitis, Ulcerative surgery, Female, Genetic Loci, Humans, Male, Polymorphism, Single Nucleotide, Risk Factors, Severity of Illness Index, Tumor Necrosis Factor Ligand Superfamily Member 15 genetics, Young Adult, Colitis, Ulcerative drug therapy, Colitis, Ulcerative genetics, Genome-Wide Association Study, Major Histocompatibility Complex genetics
- Abstract
Background: Acute severe ulcerative colitis (UC) remains a significant clinical challenge and the ability to predict, at an early stage, those individuals at risk of colectomy for medically refractory UC (MR-UC) would be a major clinical advance. The aim of this study was to use a genome-wide association study (GWAS) in a well-characterized cohort of UC patients to identify genetic variation that contributes to MR-UC., Methods: A GWAS comparing 324 MR-UC patients with 537 non-MR-UC patients was analyzed using logistic regression and Cox proportional hazards methods. In addition, the MR-UC patients were compared with 2601 healthy controls., Results: MR-UC was associated with more extensive disease (P = 2.7 × 10(-6)) and a positive family history of UC (P = 0.004). A risk score based on the combination of 46 single nucleotide polymorphisms (SNPs) associated with MR-UC explained 48% of the variance for colectomy risk in our cohort. Risk scores divided into quarters showed the risk of colectomy to be 0%, 17%, 74%, and 100% in the four groups. Comparison of the MR-UC subjects with healthy controls confirmed the contribution of the major histocompatibility complex to severe UC (peak association: rs17207986, P = 1.4 × 10(-16)) and provided genome-wide suggestive association at the TNFSF15 (TL1A) locus (peak association: rs11554257, P = 1.4 × 10(-6))., Conclusions: A SNP-based risk scoring system, identified here by GWAS analyses, may provide a useful adjunct to clinical parameters for predicting the natural history of UC. Furthermore, discovery of genetic processes underlying disease severity may help to identify pathways for novel therapeutic intervention in severe UC.
- Published
- 2010
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47. A prospective analysis of clinical variables, serologic factors, and outcome of ileal pouch-anal anastomosis in patients with backwash ileitis.
- Author
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White E, Melmed GY, Vasiliauskas EA, Dubinsky M, Berel D, Targan SR, and Fleshner PR
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Anastomosis, Surgical, Child, Colonoscopy, Enzyme-Linked Immunosorbent Assay, Female, Follow-Up Studies, Humans, Ileitis epidemiology, Ileitis immunology, Incidence, Male, Middle Aged, Pouchitis diagnosis, Pouchitis epidemiology, Pouchitis immunology, Prognosis, Prospective Studies, United States epidemiology, Young Adult, Anal Canal surgery, Antibodies, Antineutrophil Cytoplasmic immunology, Colonic Pouches immunology, Ileitis surgery, Ileum surgery
- Abstract
Purpose: The outcome of ileal pouch-anal anastomosis in patients with backwash ileitis is controversial. We prospectively compared the outcomes of ileal pouch-anal anastomosis in colitis patients with backwash ileitis and colitis patients without backwash ileitis., Methods: Consecutive colitis patients undergoing ileal pouch-anal anastomosis were reviewed. All patients were classified after surgery as being either backwash ileitis-positive or backwash ileitis-negative. Serum drawn preoperatively was assayed, using enzyme-linked immunosorbent assay, for anti-Saccharomyces cerevisiae, anti-outer membrane of porin C, anti-CBir1, anti-I2, and perinuclear anti-neutrophil cytoplasmic antibody. Outcomes included acute pouchitis (antibiotic responsive), chronic pouchitis (antibiotic dependent or refractory), or de novo Crohn's disease (small inflammation above the pouch inlet or pouch fistula)., Results: Out of 334 patients, 39 (12%) were backwash ileitis-positive. Compared with backwash ileitis-negative patients, backwash ileitis-positive patients had a higher incidence of pancolitis (100% vs 74%; P = .0001), primary sclerosing cholangitis (15% vs 2%; P = .001) and high-level (>100 enzyme-linked immunosorbent assay units/ml) perinuclear anti-neutrophil cytoplasmic antibody expression (29% vs 9%; P = .001). After a median follow-up of 26 months, 53 patients (16%) developed acute pouchitis, 37 (11%) developed chronic pouchitis, and 40 (12%) developed de novo Crohn's disease. There was no significant difference between the backwash ileitis-positive and backwash ileitis-negative patient groups in the incidence of acute pouchitis, chronic pouchitis, or de novo Crohn's disease., Conclusion: There was a significantly higher incidence of pancolitis, primary sclerosing cholangitis, and high-level perinuclear anti-neutrophil cytoplasmic antibody expression in backwash ileitis-positive patients than in backwash ileitis-negative patients. The incidence of acute pouchitis, chronic pouchitis, and de novo Crohn's disease after ileal pouch-anal anastomosis does not differ significantly between backwash ileitis-positive and backwash ileitis-negative patients.
- Published
- 2010
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48. Genome-wide association identifies multiple ulcerative colitis susceptibility loci.
- Author
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McGovern DP, Gardet A, Törkvist L, Goyette P, Essers J, Taylor KD, Neale BM, Ong RT, Lagacé C, Li C, Green T, Stevens CR, Beauchamp C, Fleshner PR, Carlson M, D'Amato M, Halfvarson J, Hibberd ML, Lördal M, Padyukov L, Andriulli A, Colombo E, Latiano A, Palmieri O, Bernard EJ, Deslandres C, Hommes DW, de Jong DJ, Stokkers PC, Weersma RK, Sharma Y, Silverberg MS, Cho JH, Wu J, Roeder K, Brant SR, Schumm LP, Duerr RH, Dubinsky MC, Glazer NL, Haritunians T, Ippoliti A, Melmed GY, Siscovick DS, Vasiliauskas EA, Targan SR, Annese V, Wijmenga C, Pettersson S, Rotter JI, Xavier RJ, Daly MJ, Rioux JD, and Seielstad M
- Subjects
- Genetic Predisposition to Disease, Genome-Wide Association Study, Humans, Membrane Proteins genetics, Meta-Analysis as Topic, Receptors, IgG genetics, Colitis, Ulcerative genetics, Polymorphism, Single Nucleotide
- Abstract
Ulcerative colitis is a chronic, relapsing inflammatory condition of the gastrointestinal tract with a complex genetic and environmental etiology. In an effort to identify genetic variation underlying ulcerative colitis risk, we present two distinct genome-wide association studies of ulcerative colitis and their joint analysis with a previously published scan, comprising, in aggregate, 2,693 individuals with ulcerative colitis and 6,791 control subjects. Fifty-nine SNPs from 14 independent loci attained an association significance of P < 10(-5). Seven of these loci exceeded genome-wide significance (P < 5 x 10(-8)). After testing an independent cohort of 2,009 cases of ulcerative colitis and 1,580 controls, we identified 13 loci that were significantly associated with ulcerative colitis (P < 5 x 10(-8)), including the immunoglobulin receptor gene FCGR2A, 5p15, 2p16 and ORMDL3 (orosomucoid1-like 3). We confirmed association with 14 previously identified ulcerative colitis susceptibility loci, and an analysis of acknowledged Crohn's disease loci showed that roughly half of the known Crohn's disease associations are shared with ulcerative colitis. These data implicate approximately 30 loci in ulcerative colitis, thereby providing insight into disease pathogenesis.
- Published
- 2010
- Full Text
- View/download PDF
49. The Ghrelin agonist TZP-101 for management of postoperative ileus after partial colectomy: a randomized, dose-ranging, placebo-controlled clinical trial.
- Author
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Popescu I, Fleshner PR, Pezzullo JC, Charlton PA, Kosutic G, and Senagore AJ
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- Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Ileus etiology, Infusions, Intravenous, Macrocyclic Compounds therapeutic use, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Ghrelin agonists, Ileus drug therapy, Macrocyclic Compounds administration & dosage, Postoperative Care methods, Proctocolectomy, Restorative adverse effects
- Abstract
Purpose: Ghrelin agonist TZP-101 is a potent prokinetic. This phase 2b study evaluated TZP-101 safety and efficacy in postoperative ileus management., Methods: Adults undergoing open partial colectomy were adaptively randomized to receive 20, 40, 80, 160, 320, 480 or 600 microg/kg TZP-101 (n = 168) or the placebo (n = 68) by 30-minute IV infusion within 1 hour of surgical closure and then daily for up to 7 days. The primary efficacy end point was the time to first bowel movement. Secondary end points included the percentage of patients with return of gastrointestinal function within 72 hours, and the time to readiness for discharge., Results: TZP-101 accelerated the time to first bowel movement in all groups, with Cox proportional hazard ratios of 1.57 (P = .056) for the low-efficacious dose (80 microg/kg) and 1.67 (P = .03) for the most efficacious dose (480 microg/kg). Using Kaplan-Meier analysis, the median time to first bowel movement was reduced in all TZP-101 groups by 10 to 22 hours vs. the placebo. A greater number of patients who received TZP-101 achieved recovery (P
- Published
- 2010
- Full Text
- View/download PDF
50. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer.
- Author
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deVos T, Tetzner R, Model F, Weiss G, Schuster M, Distler J, Steiger KV, Grützmann R, Pilarsky C, Habermann JK, Fleshner PR, Oubre BM, Day R, Sledziewski AZ, and Lofton-Day C
- Subjects
- Colorectal Neoplasms blood, Humans, Methylation, Polymerase Chain Reaction, Septins, Biomarkers, Tumor blood, Colorectal Neoplasms diagnosis, DNA blood, GTP Phosphohydrolases genetics
- Abstract
Background: The presence of aberrantly methylated SEPT9 DNA in plasma is highly correlated with the occurrence of colorectal cancer. We report the development of a new SEPT9 biomarker assay and its validation in case-control studies. The development of such a minimally invasive blood-based test may help to reduce the current gap in screening coverage., Methods: A new SEPT9 DNA methylation assay was developed for plasma. The assay comprised plasma DNA extraction, bisulfite conversion of DNA, purification of bisulfite-converted DNA, quantification of converted DNA by real-time PCR, and measurement of SEPT9 methylation by real-time PCR. Performance of the SEPT9 assay was established in a study of 97 cases with verified colorectal cancer and 172 healthy controls as verified by colonoscopy. Performance based on predetermined algorithms was validated in an independent blinded study with 90 cases and 155 controls., Results: The SEPT9 assay workflow yielded 1.9 microg/L (CI 1.3-3.0) circulating plasma DNA following bisulfite conversion, a recovery of 45%-50% of genomic DNA, similar to yields in previous studies. The SEPT9 assay successfully identified 72% of cancers at a specificity of 93% in the training study and 68% of cancers at a specificity of 89% in the testing study., Conclusions: Circulating methylated SEPT9 DNA, as measured in the new (m)SEPT9 assay, is a valuable biomarker for minimally invasive detection of colorectal cancer. The new assay is amenable to automation and standardized use in the clinical laboratory.
- Published
- 2009
- Full Text
- View/download PDF
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