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Objective: This study examined the relative effects of the second-generation antipsychotic drugs and an older representative agent on psychosocial functioning in patients with chronic schizophrenia.Method: Consenting patients were enrolled in the NIMH Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project. In phase 1, patients were randomly assigned to receive olanzapine, perphenazine, quetiapine, risperidone, or ziprasidone for up to 18 months. Clozapine was included for patients who chose this pathway after discontinuing phase 1 due to inefficacy; all other patients received another second-generation antipsychotic. Psychosocial functioning was assessed using the Quality of Life Scale.Results: Psychosocial functioning modestly improved for the one-third of phase 1 patients who reached the primary Quality of Life Scale analysis endpoint of 12 months (average effect size 0.19 SD units). Although for several of the drugs individually there were significant changes from baseline, overall there were no significant differences between the different agents. Results were similar at 6 and 18 months. There were no significant differences among the treatment groups in the amount of change in the Quality of Life Scale total score or subscale scores at 6, 12, or 18 months. Patients treated with clozapine in the efficacy pathway made comparable gains. Early treatment discontinuations, especially among patients most impaired at baseline, limited the ability to achieve more substantial functional gains.Conclusions: All antipsychotic treatment groups in all phases made modest improvements in psychosocial functioning. There were no differences among them after 6, 12, or 18 months. More substantial improvements would likely require more intensive adjunctive psychosocial rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Background: Surgical quality improvement collaboratives (QICs) aim to improve patient outcomes through coaching, benchmarked data reporting, and other activities. Although other regional QICs have formed organically over time, it is unknown whether a comprehensive quality improvement program implemented simultaneously across hospitals at the formation of a QIC would improve patient outcomes., Study Design: Patients undergoing surgery at 48 hospitals in the Illinois Surgical Quality Improvement Collaborative (ISQIC) were included. Risk-adjusted rates of postoperative morbidity and mortality were compared from baseline to year 3. Difference-in-differences analyses compared ISQIC hospitals with hospitals in the NSQIP Participant Use File (PUF), which served as a control., Results: There were 180,582 patients who underwent surgery at ISQIC-participating hospitals. Inpatient procedures comprised 100,219 (55.5%) cases. By year 3, risk-adjusted rates of death or serious morbidity decreased in both ISQIC (relative reduction 25.0%, p < 0.001) and PUF hospitals (7.8%, p < 0.001). Adjusted difference-in-differences analysis revealed that ISQIC participation was associated with a significantly greater reduction in death or serious morbidity (odds ratio 0.94, 95% CI 0.90 to 0.99, p = 0.01) compared with PUF hospitals. Relative reductions in risk-adjusted rates of other outcomes were also seen in both ISQIC and PUF hospitals (morbidity 22.4% vs 6.4%; venous thromboembolism 20.0% vs 5.0%; superficial surgical site infection 27.3% vs 7.7%, all p < 0.05), although these difference-in-differences did not reach statistical significance., Conclusions: Although complication rates decreased at both ISQIC and PUF hospitals, participation in ISQIC was associated with a significantly greater improvement in death or serious morbidity. These results underscore the potential of QICs to improve patient outcomes., (Copyright © 2023 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Preoperative radiotherapy has improved outcomes in rectal cancer patients, however, the optimal interval between radiation and proctectomy is unknown. A review of contemporary literature suggests an 8-12 week interval between radiation and surgery likely improves tumor response rates for rectal cancer patients undergoing proctectomy, which may convey modest improvements in long-term oncologic outcomes. Prolonged radiation-surgery intervals may expose surgeons to pelvic fibrosis, however, which may impact later-term proctectomies and compromise perioperative and oncologic outcomes., (© 2023 The Authors. Journal of Surgical Oncology published by Wiley Periodicals LLC.)

Introduction: In 2014, 56 Illinois hospitals came together to form a unique learning collaborative, the Illinois Surgical Quality Improvement Collaborative (ISQIC). Our objectives are to provide an overview of the first three years of ISQIC focused on (1) how the collaborative was formed and funded, (2) the 21 strategies implemented to support quality improvement (QI), (3) collaborative sustainment, and (4) how the collaborative acts as a platform for innovative QI research., Methods: ISQIC includes 21 components to facilitate QI that target the hospital, the surgical QI team, and the peri-operative microsystem. The components were developed from available evidence, a detailed needs assessment of the hospitals, reviewing experiences from prior surgical and non-surgical QI Collaboratives, and interviews with QI experts. The components comprise 5 domains: guided implementation (e.g., mentors, coaches, statewide QI projects), education (e.g., process improvement (PI) curriculum), hospital- and surgeon-level comparative performance reports (e.g., process, outcomes, costs), networking (e.g., forums to share QI experiences and best practices), and funding (e.g., for the overall program, pilot grants, and bonus payments for improvement)., Results: Through implementation of the 21 novel ISQIC components, hospitals were equipped to use their data to successfully implement QI initiatives and improve care. Formal (QI/PI) training, mentoring, and coaching were undertaken by the hospitals as they worked to implement solutions. Hospitals received funding for the program and were able to work together on statewide quality initiatives. Lessons learned at one hospital were shared with all participating hospitals through conferences, webinars, and toolkits to facilitate learning from each other with a common goal of making care better and safer for the surgical patient in Illinois. Over the first three years, surgical outcomes improved in Illinois., Discussion: The first three years of ISQIC improved care for surgical patients across Illinois and allowed hospitals to see the value of participating in a surgical QI learning collaborative without having to make the initial financial investment themselves. Given the strong support and buy-in from the hospitals, ISQIC has continued beyond the initial three years and continues to support QI across Illinois hospitals., Competing Interests: The authors declare no conflicts of interest.

Introduction: With widespread adoption of enhanced recovery protocols and a push toward shorter length of stay (LOS) following colon surgery, the extent to which complications have shifted to the post-discharge setting is unknown. The objectives of this study were to (1) characterize changes in LOS and post-discharge complications over time and (2) evaluate risk factors associated with post-discharge complications., Methods: Patients who underwent elective colon resection from 2012 to 2018 were identified from the ACS NSQIP Colectomy-Targeted Dataset. Changes in LOS and the proportion of post-discharge complications were evaluated over time, and predictors of post-discharge complications were assessed using multivariable logistic regression., Results: Of the 98,136 patients who underwent colon resection, median LOS decreased from 5 days in 2012 to 4 days in 2018. Overall, 30-day complication rate was 21.5%, which decreased during the study period (25.8 to 19.1%, p < 0.001). Of the 13 individual complications evaluated, 4 demonstrated a significant increase in the proportion of post-discharge events including overall SSI (55.8 to 63.3%, p = 0.002), superficial SSI (57.3 to 75.7%, p < 0.001), wound disruption (46.0 to 62.1%, p = 0.047), and UTI (41.5 to 62.7%, p < 0.001). Factors associated with the development of any post-discharge complication included female sex, ASA III/IV/V, dependent functional status, and higher BMI. Intraoperative factors included wound class, operation time, and approach., Conclusions: Although LOS and 30-day complications decreased over time, the proportion of events occurring post-discharge increased for several complications. We identified specific factors associated with post-discharge complications which emphasize the importance of a patient monitoring program to early identify and manage post-discharge complications., (© 2022. The Society for Surgery of the Alimentary Tract.)

Background: Surgical site infection reduction bundles are effective but can be complex and resource intensive. Understanding which bundle elements are associated with reduced surgical site infections may guide concise bundle implementation., Objective: The purpose of this study was to evaluate the association of individual surgical site infection reduction bundle elements with infection rates., Design: This was a post-hoc analysis of a prospective cohort study., Setting: This study took place at Illinois Surgical Quality Improvement Collaborative hospitals., Patients: Patients who had elective colorectal resections at participating hospitals from 2016 to 2017., Interventions: The intervention was a 16-element colorectal surgical site infection reduction bundle., Main Outcome Measures: Surgical site infection rates were compared among patients by adherence with each bundle element using χ 2 tests and multivariable logistic regression. Principal component analysis identified composites of correlated bundle elements. Coincidence analysis identified combinations of bundle elements or principal component composites associated with the absence of surgical site infection., Results: Among 2722 patients, 192 (7.1%) developed a surgical site infection. Infections were less likely when oral antibiotics (OR 0.63 [95% CI 0.41-0.97]), wound protectors (OR 0.55 [95% CI 0.37-0.81]), and occlusive dressings (OR 0.71 [95% CI 0.51-1.00]) were used. Bundle elements were reduced into 5 principal component composites. Adherence with the combination of oral antibiotics, wound protector, or redosing intravenous antibiotic prophylaxis plus chlorhexidine-alcohol intraoperative skin preparation was associated with the absence of infection (consistency = 0.94, coverage = 0.96). Four of the 5 principal component composites in various combinations were associated with the absence of surgical site infection, whereas the composite consisting of occlusive dressing placement, postoperative dressing removal, and daily postoperative chlorhexidine incisional cleansing had no association with the outcome., Limitations: The inclusion of hospitals engaged in quality improvement initiatives may limit the generalizability of these data., Conclusion: Bundle elements had varying association with infection reduction. Implementation of colorectal surgical site infection reduction bundles should focus on the specific elements associated with low surgical site infections. See Video Abstract at http://links.lww.com/DCR/B808 ., Desempaquetando Paquetes Evaluacin De La Asociacin De Elementos Individuales Del Paquete De Reduccin De Infecciones Del Sitio Quirrgico Colorrectal Con Las Tasas De Infeccin En Una Colaboracin Estatal: ANTECEDENTES:Los paquetes de reducción de infecciones del sitio quirúrgico son efectivos pero pueden ser complejos y requieren muchos recursos. Comprender qué elementos del paquete están asociados con la reducción de las infecciones del sitio quirúrgico puede guiar la implementación concisa del paquete.OBJETIVO:Evaluar la asociación de los elementos individuales del paquete de reducción de infecciones del sitio quirúrgico con las tasas de infección.DISEÑO:Análisis post-hoc de un estudio de cohorte prospectivo.ESCENARIO:Hospitales colaborativos para la mejora de la calidad quirúrgica de Illinois.PACIENTES:Resecciones colorrectales electivas en los hospitales participantes entre 2016 y 2017.INTERVENCIONES:Paquete de reducción de infección del sitio quirúrgico colorrectal de 16 elementos.PRINCIPALES MEDIDAS DE RESULTADO:Se compararon las tasas de infección del sitio quirúrgico entre los pacientes según la adherencia con cada elemento del paquete mediante pruebas de Chi cuadrado y regresión logística multivariable. El análisis de componentes principales identificó compuestos de elementos de paquete correlacionados. El análisis de coincidencia identificó combinaciones de elementos del haz o compuestos de componentes principales asociados con la ausencia de infección del sitio quirúrgico.RESULTADOS:Entre 2722 pacientes, 192 (7,1%) desarrollaron una infección del sitio quirúrgico. Las infecciones fueron menos probables cuando se administraron antibióticos orales (OR 0,63 (IC 95% 0,41-0,97)), protectores de heridas (OR 0,55 (IC 95% 0,37-0,81)) y vendajes oclusivos (OR 0.71 (IC 95% 0,51-1,00]) fueron usados. Los elementos del paquete se redujeron a 5 grupos de componentes principales. La adherencia a la combinación de (1) antibióticos orales, (2) protector de heridas o (3) redosificación de profilaxis antibiótica intravenosa más preparación de la piel intraoperatoria con clorhexidina-alcohol se asoció con la ausencia de infección (consistencia = 0,94, cobertura = 0,96). Cuatro de los cinco grupos de componentes principales en varias combinaciones se asociaron con la ausencia de infección del sitio quirúrgico, mientras que el grupo que consiste en la colocación del apósito oclusivo, la remosión del apósito en posoperatorio y la limpieza incisional posoperatoria diaria con clorhexidina no tuvo asociación con el resultado.LIMITACIONES:La inclusión de hospitales que participan en iniciativas de mejora de la calidad puede limitar la generalización de estos datos.CONCLUSIONES:Los elementos del paquete tuvieron una asociación variable con la reducción de la infección. La implementación de paquetes de reducción de infecciones del sitio quirúrgico colorrectal debe centrarse en los elementos específicos asociados con pocas infecciones del sitio quirúrgico. Consulte Video Resumen en http://links.lww.com/DCR/B808 . (Traducción-Juan Carlos Reyes )., (Copyright © The ASCRS 2021.)

Background: Adherence to bundled interventions can reduce surgical site infection (SSI) rates; however, predictors of successful implementation are poorly characterized. We studied the association of patient and hospital characteristics with adherence to a colorectal SSI reduction bundle across a statewide surgical collaborative., Study Design: A 16-component colorectal SSI reduction bundle was introduced in 2016 across a statewide quality improvement collaborative. Bundle adherence was measured for patients who underwent colorectal operations at participating institutions. Multivariable mixed-effects logistic regression models were constructed to estimate associations of patient and hospital factors with bundle adherence and quantify sources of variation., Results: Among 2,403 patients at 35 hospitals, a median of 11 of 16 (68.8%, interquartile range 8 to 13) bundle elements were completed. The likelihood of completing 11 or more elements was increased for obese patients (56.8% vs 51.5%, odds ratio [OR] 1.39, 95% CI 1.05 to 1.86, p = 0.022) but reduced for underweight patients (31.0% vs 51.5%, OR 0.51, 95% CI 0.26 to 1.00, p = 0.048) compared with patients with a normal BMI. Lower adherence was noted for patients treated at safety net hospitals (n = 9 hospitals, 24.4% vs 54.4%, OR 0.08, 95% CI 0.01 to 0.44, p = 0.004). The largest proportion of adherence variation was attributable to hospital factors for six bundle elements, surgeon factors for no elements, and patient factors for nine elements., Conclusion: Adherence to an SSI reduction bundle is associated with patient BMI and hospital safety net status. Quality improvement groups should consider institutional traits for optimal implementation of SSI bundles. Safety net hospitals may require additional focus to overcome unique implementation barriers., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Understanding modifiable surgical risk factors is essential for preoperative optimization. We evaluated the association between smoking and complications following major gastrointestinal surgery., Methods: Patients who underwent elective colorectal, pancreatic, gastric, or hepatic procedures were identified in the 2017 ACS NSQIP dataset. The primary outcome was 30-day death or serious morbidity (DSM). Secondary outcomes included pulmonary complications, wound complications, and readmission. Multivariable logistic regression was used to evaluate the association between smoking and these outcomes., Results: A total of 46,921 patients were identified, of whom 7,671 (16.3%) were smokers. Smoking was associated with DSM (23.2% vs. 20.4%, OR 1.15 [1.08-1.23]), wound complications (13.0% vs. 10.4%, OR 1.24 [1.14-1.34]), pulmonary complications (4.9% vs 2.9%, OR 1.93 [1.70-2.20]), and unplanned readmission (12.6% vs. 11%, OR 1.14 [95% CI 1.06-1.23])., Conclusions: Smoking is associated with complications following major gastrointestinal surgery. Patients who smoke should be counseled prior to surgery regarding risks., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Previous studies have focused on the development and evaluation of care bundles to reduce the risk of surgical site infection (SSI) throughout the perioperative period. A focused examination of the technical/surgical aspects of SSI reduction during CRS has not been conducted. This study aimed to develop an expert consensus on intraoperative technical/surgical aspects of SSI prevention by the surgical team during colorectal surgery (CRS)., Study Design: In a modified Delphi process, a panel of 15 colorectal surgeons developed a consensus on intraoperative technical/surgical aspects of SSI prevention undertaken by surgical personnel during CRS using information from a targeted literature review and expert opinion. Consensus was developed with up to three rounds per topic, with a prespecified threshold of ≥70% agreement., Results: In 3 Delphi rounds, the 15 panelists achieved consensus on 16 evidence-based statements. The consensus panel supported the use of wound protectors/retractors, sterile incision closure tray, preclosure glove change, and antimicrobial sutures in reducing SSI along with wound irrigation with aqueous iodine and closed-incision negative pressure wound therapy in high-risk, contaminated wounds., Conclusions: Using a modified Delphi method, consensus has been achieved on a tailored set of recommendations on technical/surgical aspects that should be considered by surgical personnel during CRS to reduce the risk of SSI, particularly in areas where the evidence base is controversial or lacking. This document forms the basis for ongoing evidence for the topics discussed in this article or new topics based on newly emerging technologies in CRS., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American College of Surgeons.)

Background: Guidelines recommend extended chemoprophylaxis for venous thromboembolism in high-risk patients having operations for inflammatory bowel disease. Quantifying patients' risk of venous thromboembolism, however, remains challenging. We sought (1) to identify factors associated with postdischarge venous thromboembolism in patients undergoing colorectal resection for inflammatory bowel disease and (2) to develop a postdischarge venous thromboembolism risk calculator to guide prescribing of extended chemoprophylaxis., Methods: Patients who underwent an operation for inflammatory bowel disease from 2012 to 2018 were identified from the American College of Surgeons National Surgical Quality Improvement Program for colectomy and proctectomy procedure targeted modules. Postdischarge venous thromboembolism included pulmonary embolism or deep vein thrombosis diagnosed after discharge from the index hospitalization. Multivariable logistic regression estimated the association of patient/operative factors with postdischarge venous thromboembolism. A postdischarge venous thromboembolism risk calculator was subsequently constructed., Results: Of 18,990 patients, 199 (1.1%) developed a postdischarge venous thromboembolism within the first 30 postoperative days. Preoperative factors associated with postdischarge venous thromboembolism included body mass index (1.9% with body mass index ≥35 vs 0.8% with body mass index 18.5-24.9; odds ratio 2.34 [95% confidence interval 1.49-3.67]), steroid use (1.3% vs 0.7%; odds ratio 1.91 [95% confidence interval 1.37-2.66]), and ulcerative colitis (1.5% vs 0.8% with Crohn's disease; odds ratio 1.76 [95% confidence interval 1.32-2.34]). Minimally invasive surgery was associated with postdischarge venous thromboembolism (1.2% vs 0.9% with open; odds ratio 1.42 [95% confidence interval 1.05-1.92]), as was anastomotic leak (2.8% vs 1.0%; odds ratio 2.24 [95% confidence interval 1.31-3.83]) and ileus (2.1% vs 0.9%; odds ratio 2.60 [95% confidence interval 1.91-3.54]). The predicted probability of postdischarge venous thromboembolism ranged from 0.2% to 14.3% based on individual risk factors., Conclusion: Preoperative, intraoperative, and postoperative factors are associated with postdischarge venous thromboembolism after an operation for inflammatory bowel disease. A postdischarge venous thromboembolism risk calculator was developed which can be used to tailor extended venous thromboembolism chemoprophylaxis by individual risk., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Our objective was to examine the implementation and associated clinical outcomes of a comprehensive surgical site infection (SSI) reduction bundle in a large statewide surgical quality improvement collaborative leveraging a multifaceted implementation strategy., Summary Background Data: Bundled perioperative interventions reduce colorectal SSI rates when enacted at individual hospitals, but the ability to implement comprehensive SSI bundles and to examine the resultant clinical effectiveness within a larger, diverse population of hospitals is unknown., Methods: A multifaceted SSI reduction bundle was developed and implemented in a large statewide surgical quality improvement collaborative through a novel implementation program consisting of guided implementation, data feedback, mentorship, process improvement training/coaching, and targeted-implementation toolkits. Bundle adherence and ACS NSQIP outcomes were examined preimplementation versus postimplementation., Results: Among 32 hospitals, there was a 2.5-fold relative increase in the proportion of patients completing at least 75% of bundle elements (preimplementation = 19.5% vs. postimplementation = 49.8%, P = 0.001). Largest adherence gains were seen in wound closure re-gowning/re-gloving (24.0% vs. 62.0%, P < 0.001), use of clean closing instruments (32.1% vs. 66.2%, P = 0.003), and preoperative chlorhexidine bathing (46.1% vs. 77.6%, P < 0.001). Multivariable analyses showed a trend toward lower risk of superficial incisional SSI in the postimplementation period compared to baseline (OR 0.70, 95% CI 0.49-10.2, P = 0.06). As the adherence in the number of bundle elements increased, there was a significant decrease in superficial SSI rates (lowest adherence quintile, 4.6% vs. highest, 1.5%, P < 0.001)., Conclusions: A comprehensive multifaceted SSI reduction bundle can be successfully implemented throughout a large quality improvement learning collaborative when coordinated quality improvement activities are leveraged, resulting in a 30% decline in SSI rates. Lower superficial SSI rates are associated with the number of adherent bundle elements a patient receives, rendering considerable benefits to institutions capable of implementing more components of the bundle.

Background: A 59-year-old woman with strong family history of early-age colorectal cancer was found to have synchronous tubular adenomas of the duodenum and transverse colon during surveillance endoscopy 12 years after undergoing right colectomy and adjuvant chemotherapy for stage II colon adenocarcinoma. The duodenal lesion was endoscopically unresectable due to central depression, and the transverse colon adenoma was unresectable because it was confluent with the previous ileocolic anastomosis. Given the synchronous unresectable lesions in the setting of an Amsterdam positive kindred, the patient underwent simultaneous pancreaticoduodenectomy and completion total abdominal colectomy with ileorectal anastomosis. Histopathologic analysis of the specimens revealed T4N0 poorly differentiated MLH1 deficient duodenal adenocarcinoma with pancreatic invasion and tubular adenoma of the colon with high grade dysplasia. Following adjuvant chemotherapy, there is no evidence of recurrent cancer after two years of surveillance., Summary: While the crude overall risk for small bowel and periampullary tumors remains low, clinicians must maintain awareness of a relatively increased risk of extracolonic tumors in Lynch syndrome (LS) patients., Conclusion: LS patients have an increased risk for developing small bowel cancer (SBC) when compared to the general population. However, given the low incidence of these tumors and uncertain efficacy of contemporary screening modalities, surveillance of the small bowel has not been recommended. The current case report exemplifies the challenges associated with waiting for patients to develop symptoms to develop before investigating for SBC., Competing Interests: DISCLOSURE: The authors have no conflicts of interest to disclose.

Background: We sought to evaluate the results of a new mesh sutured repair technique for closure of contaminated incisional hernias., Methods: 48 patients with contaminated hernias 5 cm wide or greater by CT scan were closed with mesh sutures. Surgical site occurrence, infections, and hernia recurrence were compared to similar patient series reported in the literature., Results: Of the 48 patients, 20 had clean-contaminated wounds, 16 had contaminated wounds, and 12 were infected. 69% of the patients underwent an anterior perforator sparing components release for hernias that averaged 10.5 cm transversely (range 5 cm-25 cm). SSO occurred in 27% of patients while SSI was 19%. There were no fistulas or delayed suture sinuses. With a mean follow-up of almost 12 months, 3 midline hernias recurred (6%). In these same patients, three parastomal hernias repaired with mesh sutures failed out of 4 attempted for a total failure rate of 13%., Conclusion: Mesh sutured closure represents a simplified and effective surgical strategy for contaminated midline incisional hernia repair., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Intestinal stomas significantly impact patients' quality of life. Stoma-related complications are common, but even without complications, patients are faced with new challenges in stoma management and daily activities. Preoperative patient education and stoma site marking, in conjunction with conscientious surgical stewardship, are key to patient satisfaction and successful operative outcomes.

Purpose: The precise definition of the rectum is essential for localizing colorectal pathology, yet current definitions are nebulous. The objective of this study is to determine the anthropometric definition of common pelvic landmarks in relation to patient characteristics., Methods: Seventy-one patients underwent open proctectomy with intra-operative measurements from the anal verge to various pelvic landmarks, and patient characteristics were evaluated. Analyses were performed using Spearman correlation and Wilcoxon rank sum., Results: The mean landmark distance was dentate line = 1.7 cm (range 0.8-4.0 cm), puborectalis muscle = 4.2 cm (range 2.0-8.0 cm), anterior peritoneal reflection = 13.2 cm (range 8.5-21.0 cm), sacral promontory = 17.9 cm (range 13.0-26.0 cm), and confluence of the taenia = 25.5 cm (range 16.0-44.0 cm). Men had longer mean distances to the dentate line (p = 0.0003), puborectalis muscle (p = 0.03), and anterior peritoneal reflection (p = 0.02). Patient weight significantly correlated with distance to all landmarks except for the confluence of the taenia, which did not correlate with any patient factor., Conclusions: The location of common pelvic landmarks is highly variable. The use of predefined absolute measurements from the anal verge to localize rectal pathology is inaccurate and fails to account for patient variability.

Purpose: Several methods have been used to measure quality of life (QOL) in colorectal patients, but existing QOL assessment tools are often complex, require complicated analysis, lack specificity for colorectal surgery, and are not focused on assessment of perioperative care. The postoperative QOL (PQL) assessment is designed to capture subtle yet important QOL factors in an easy tool validated for the postoperative period. Although internally validated, PQL lacks external validation with a universally accepted QOL metric, such as the Rand Short Form-36 (SF-36). The purpose of this study was to externally validate the PQL metric to the SF-36 for colorectal surgery., Methods: The PQL was designed using 14 questions ranked on a Likert scale (1-10) with surgeon and patient input. After obtaining institutional review board approval, 100 consecutive colorectal surgery patients at University Hospitals, Case Medical Center were administered baseline and postoperative (2, 4, 8, 12, 30, 60, and 90 days) PQL and SF-36 questionnaires prospectively. Patients undergoing colorectal surgery via an abdominal approach (laparoscopic or open) for benign or malignant disease were included. Factor analysis and Spearman's rank test were performed between each of the 8 SF-36 scales and the 14 PQL questions and summary score. Convergent validity was demonstrated using Spearman's correlation coefficient at the domain and scale levels. The degree of agreement between PQL and SF-36 was assessed through Bland-Altman plots. Pairwise comparisons were made to determine any significant differences between the 2 scales., Results: Eighty-eight patients met all inclusion criteria and had a complete dataset, and were included in the analysis. SF-36 factor analysis confirmed comparability between the study group and the general population. All PQL items correlated with all 8 mental and physical health domains in the SF-36 (P < .0001). Bland-Altman plots demonstrated consistently similar measure for level of agreement between PQL and SF-36 as indicated by the 95% limits of agreement., Conclusion: The PQL and SF-36 demonstrated a strong and consistent level of agreement across all 8 domains for pre- and postoperative scores in colorectal surgery patients. PQL is constructually valid in the perioperative period. Based on our analysis, the novel PQL metric represents a simple, point-of-care alternative to SF-36 for rapid QOL assessment, and validates use of the PQL metric in abdominal surgery., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: Endoscopic radiofrequency ablation (RFA) has been used effectively for ablation of foregut disorders and also may have a role in treating colonic pathology. This study aimed to assess the feasibility of delivering RFA to locations within the colon and to determine a range of safe treatment parameters., Methods: Patients undergoing left hemicolectomy or proctocolectomy were evaluated. Focal RFA using a colonoscope-mounted device was delivered to normal segments of the colon and rectum within the planned surgical resection specimen. Endoscopic accessibility and feasibility of delivering heat energy to the colon and rectum were assessed as well as the maximum incurred histologic depth of ablation in relation to the number of applications (2 or 4) and the energy density (12, 15, or 20 J/cm2)., Results: A total of 51 ablation zones in 16 patients had available histopathology. None of the sites receiving two applications demonstrated serosal layer alteration compared with 15% of the sites receiving four applications (p=0.11). Muscularis propria alterations were seen in 25% of the two-application sites and 63% of the four-application sites (p<0.05). Increasing energy density from 12 to 20 J/cm2 did not correlate with a deeper ablation effect., Conclusions: Endoscopic RFA is capable of delivering therapy to the distal colon. Injury is limited to the muscularis propria or less depth when no more than two ablations are applied regardless of the energy density used. Based on these feasibility and dosimetry results, the authors will continue investigation using these and smaller energy doses to initiate trials ultimately with patients who have suitable mucosal and submucosal disorders of the lower gastrointestinal tract including chronic, nonulcerated hemorrhagic radiation proctitis and angiodyplasia.

Background: Evaluation of a potential source for abdominal sepsis in a critically ill patient can be challenging. With flexible endoscopy readily available in this setting, we sought to evaluate the diagnostic efficacy of a transgastric natural orifice transluminal endoscopic surgery (NOTES) peritoneoscopy vs. laparoscopic exploration in the identification of intra-abdominal pathology in a porcine model., Methods: In this acute study, 15 pigs were randomized to demonstrate 0 to 4 pathologic lesions: small bowel ischemia (SBI), small bowel perforation (SBP), colon perforation (CP), and gangrenous cholecystitis (GC). Two blinded surgical endoscopists were allowed 60 min to perform NOTES or laparoscopy (LAP) to correctly identify or exclude each lesion. A prototype endoscope (R-scope, Olympus, Inc), which enables independent instrument mobility, was used in the NOTES arm., Results: When considering all lesions, LAP was more sensitive diagnostically than NOTES (77.4% vs. 61.3%) overall. LAP also displayed a slightly higher NPV compared with NOTES (79.4% vs. 70.7%). However, NOTES was 100% specific with 100% positive predictive value (PPV) compared with 93.1% and 92.3% with LAP, respectively. Individually, NOTES was found most sensitive with CP identification (87.5%) and least sensitive with SBP (37.5%). The sensitivity of NOTES for SBI and GC was 62.5% and 57.1%, respectively., Conclusions: The utilization of NOTES as a diagnostic tool may have an important role in the critically ill patient when operative intervention is highly morbid. Although it may be overall inferior diagnostically compared with laparoscopy, a positive identification was highly specific with a strong predictive value. Further investigation addressing an improved small bowel evaluation technique would be beneficial. A human trial of NOTES in the ICU utilizing the current technology would still initially mandate laparoscopic or open surgical confirmation and treatment.

Background: Diagnostic natural-orifice transluminal endoscopic surgery (NOTES) peritoneoscopy can easily be performed with standard endoscopic equipment in animal studies. The efficacy and optimal transgastric site for NOTES access in humans, however, has not been determined., Objective: To characterize the efficacy of various anterior gastric access locations for diagnostic transgastric NOTES peritoneoscopy in humans., Design: Prospective clinical study., Setting: Tertiary-care center with experience in NOTES peritoneoscopy., Patients: Patients undergoing planned laparoscopic gastrectomy or gastrotomy involving the anterior aspect of the stomach were eligible., Interventions: An anterior gastric site for NOTES gastrotomy was chosen and transgastric NOTES access was independently established after laparoscopic abdominal exploration. Peritoneoscopy was then performed. The site of gastrotomy was closed as part of the intended laparoscopic procedure., Main Outcome Measures: The ability to visualize the abdominal and pelvic organs in all four quadrants was determined. Patients were evaluated postoperatively for complications., Results: Eight patients requiring 9 procedures were studied. Gastrotomy sites were classified as body (n = 3), lesser curvature (n = 3), greater curvature (n = 1), fundus (n = 1), and antrum (n = 1). Satisfactory navigation could only be performed to the right upper and both lower quadrants. The left upper quadrant, specifically the spleen, was adequately visualized in only 1 case (11%), where the gastrotomy site was at the greater curvature. One patient developed a surgical site infection requiring oral antibiotic therapy. The median postoperative stay was 2 days (range, 0-3 days)., Limitations: Small number of patients., Conclusion: NOTES peritoneoscopy with a gastrotomy on the anterior stomach permits adequate visualization of organs in the right upper and both lower quadrants. Visualization of the left upper quadrant and spleen is, however, limited unless access is gained on the greater curvature of the stomach. The accuracy of NOTES in identifying intra-abdominal pathology compared with laparoscopy remains to be determined., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Purpose: Collagen anal fistula plug treatment of transsphincteric fistulas produces variable results. The purpose of our study was to determine whether long-tract fistulas (>4 cm) correlated with successful closure., Methods: All patients undergoing transsphincteric cryptoglandular fistula repair with anal fistula plugs were enrolled in a prospective database. Patients with Crohn's disease were excluded. Fistula tract length was measured intraoperatively by subtracting the remaining plug length from the original plug size. All procedures used standardized techniques and postoperative care pathways. The primary outcome was complete fistula closure assessed through both postoperative outpatient visits and a follow-up telephone questionnaire., Results: Forty-one patients with 42 fistula tracks were enrolled over a 39-month period. Complete closure was achieved in 18 of 42 (43%) fistulas at a mean follow-up of 25 months. Closure was not associated with gender, age, tract location, duration of seton, or length of follow-up. Successful closure was significantly associated with increased tract length, because fistulas longer than 4 cm were nearly 3 times more likely to heal compared with shorter fistulas ((14/23, 61%) vs (4/19, 21%), P = .004; relative risk = 2.8; 95% CI 1.14-7.03)., Conclusions: Anal fistula plug repair of cryptoglandular anorectal fistulas is more successful for long-tract fistulas. Although the overall success is modest, limiting surgical indications to fistulas exceeding 4 cm may maximize benefits of the plug technique.

Background: The immunologic and physiologic effects of natural orifice translumenal endoscopic surgery (NOTES) versus traditional surgical approaches are poorly understood. Previous investigations have shown that NOTES and laparoscopy share similar inflammatory cytokine profiles except for a possible late-phase tissue necrosis factor-alpha (TNF-alpha) depression with NOTES. The local peritoneal reaction and immunomodulatory influence of pneumoperitoneum agents in NOTES also are not known and may play an important role in altering the physiologic insult induced by NOTES., Methods: In this study, 51 animals were divided into four study groups, which respectively underwent abdominal exploration via transgastric NOTES using room air (AIR) or carbon dioxide (CO(2)) or via laparoscopy (LX) using AIR or CO(2) for pneumoperitoneum. Laparotomy and sham surgeries were additionally performed as control conditions. Measurements of TNF-alpha, interleukin-1beta (IL-1beta), and IL-6 were performed for peritoneal fluid collected after 0, 2, 4, and 6 h and on postoperative days (PODs) 1, 2, and 7., Results: Of the 45 animals assessed, 6 were excluded because of technical operative complications. The findings showed that LX-CO(2) generated the most pronounced response with all three inflammatory markers. However, no significant differences were detected between LX-CO(2) and either NOTES group at these peak points. No differences were encountered between NOTES-CO(2) and NOTES-AIR. Subgroup comparisons showed significantly higher levels of TNF-alpha and IL-6 with NOTES-CO(2) than with LX-AIR on POD 1 (p = 0.022) and POD 2 (p = 0.002). The LX-CO(2) subgroup had significantly higher levels of TNF-alpha than the LX-AIR subgroup at 4 h (p = 0.013) and on POD 1 (p = 0.021). No late-phase TNF-alpha depression occurred in the NOTES animals., Conclusion: The local inflammatory reaction to NOTES was similar to that with traditional laparoscopy, and the previously described late-phase systemic TNF-alpha depression in serum was not reproduced. At the peritoneal level, NOTES is no more physiologically stressful than laparoscopy. Furthermore, regardless of which gas was used, the role of the pneumoperitoneum agent did not affect the cytokine profile after NOTES, suggesting that air pneumoperitoneum is adequate for NOTES.

Despite the prevalence and severe implications of rectovaginal fistula, there is no universally accepted evidence-based approach to surgical management. This article offers a disease-based review of traditional management strategies and highlights the variety of technical approaches that are currently effective for the eradication of this socially disabling condition., (Copyright 2010. Published by Elsevier Inc.)

Background: Even with the advent of bioresorbable barriers, complications due to visceral adhesions following surgery continue to occur. The use of a homologous adhesive barrier such as human peritoneal membrane (HPM) could prevent adhesions formation and enhance wound healing. This study evaluates HPM as an effective adhesive barrier in a porcine model simulating a ventral hernia procedure., Materials and Methods: Through a midline laparotomy, meshes (10 cmx10 cm) were sewn onto the intact peritoneum of a pig, on each side of a midline incision in superior and inferior positions (4 randomized meshes/pig, n=9 pigs). The pigs were survived for 90 d. The meshes used were: HPM, compressed polytetrafluoro-ethylene (cPTFE), cPTFE+HPM, and polyester-collagen composite (PX). Exploratory laparoscopy was performed at 30 and 90 d to evaluate the extent of visceral adhesions. At necropsy, the extent and tenacity of visceral adhesions as well as material-abdominal wall integration were evaluated. Finally, host tissue response was assessed through scoring of inflammation, foreign body reaction, and mesothelialization., Results: HPM and PX led to the least extent and tenacity of visceral adhesions compared to cPTFE and cPTFE+HPM, but integrated less strongly within the adjacent abdominal wall. PX displayed the most robust foreign body reaction among all prosthetic materials, while HPM scored similarly to the native peritoneum. The extent of mesothelialization was similar throughout the materials tested., Conclusions: The HPM barrier which promotes long-term peritoneal remodeling could diminish postsurgical intraperitoneal adhesions following hernia repair.

Background: Few studies exist that evaluate outcomes of pancreatectomy in patients > or =80 y of age, an age group increasing in size in the United States. This study analyzes the outcomes of pancreatectomy in patients > or =80 y of age., Methods: The medical records of 32 patients > or =80 y of age undergoing pancreatectomy at our institution from April 1995 through October 2008 were reviewed, and outcomes were analyzed., Results: The median patient age was 82 y, and 75% were ASA Class 3. Eighty-one percent of the resections were pancreaticoduodenectomies. There were no operative deaths. Sixty-six percent of patients suffered at least one complication. The median length of stay was 11 d. Eighty-one percent of the resections were performed for cancer. Median survival for all patients was 14.4 mo. Median survival for patients with cancer was 12 mo versus 103 mo for patients without cancer, P = 0.017., Conclusions: Pancreatectomy in patients > or =80 y of age can be performed with a low risk of mortality but with significant morbidity.

Background and Study Aims: Reliable and secure closure of the gastrotomy after natural-orifice transluminal endoscopic surgery (NOTES) remains a critical step for widespread acceptance and use of this mode of surgery. We describe a novel method for gastrotomy closure using endoscopic tissue anchors., Methods: A standard upper endoscopy and wire placement as used for percutaneous endoscopic gastrostomy placement was performed in five pigs. Prior to gastrotomy, four tissue anchors were placed in four quadrants (1 cm away from the wire). A 12-mm gastrotomy was created endoscopically using a combination of needle-knife and balloon dilation. After transgastric peritoneoscopy, the sutures were approximated using a device knotting element. One additional pair of sutures was placed after evaluation of the gastric closure. The animals underwent in vivo contrast fluoroscopy, methylene blue instillation, and bursting pressure studies for assessment of the closure site., Results: All animals studied showed complete sealing of the gastrotomy site without evidence of leak on fluoroscopic imaging or at final postmortem intragastric methylene blue instillation. Improved insufflation ability following gastrotomy was also noted using this technique, which enhanced overall visualization during the closure., Conclusion: Positioning tissue anchors prior to creating a NOTES gastrotomy was a feasible and reliable method to perform gastric closure. Follow-up survival studies will be warranted to support these preliminary findings.

Chronic wounds are a major secondary complication for many people with impaired mobility. Electrical stimulation (ES) has been recommended as a adjunctive therapy, however optimal treatment paradigms have not been established. Our group seeks to determine the basic mechanisms underlying ES wound therapy, an area where understanding is currently limited. A feasibility study was carried out to develop the Ahn/Mustoe lapine wound model for systematic investigation of the effects of electrical stimulation on ischemic wound therapy. A standardized surgical procedure incorporated a hybrid stimulation system comprising an implantable mini-stimulator and surface electrodes, with creation of repeatable ischemic wounds. Twenty mature male New Zealand white rabbits (3 kg weight) were employed to evaluate the effects of two empirically selected stimulation paradigms applied continuously for 7-21 days, using each animal as its own control. Outcomes measures included transcutaneous blood gas levels, histology, total RNA content and analysis of alpha2 (I) collagen (COL-I), type IV collagen (COL-IV), alpha1 (V) collagen (COL-V), and vascular endothelial growth factor (VEGF) expression using real-time quantitative PCR. All markers for stimulated wounds showed increased activity relative to non-stimulated control wounds between 7 and 14 days following injury, with peak activity at 14 days. By 21 days post-injury, all activity had returned to near baseline level. VEGF and COL-IV levels were found to be significantly higher for pattern A (110 mus pulse width) compared to pattern B (5 mus pulse width) at 14 days, implying that pattern A may be more effective at promoting angiogenesis. All wounds were fully re-epithelialized by 10 days post-injury. Both COL-I and COL-V showed statistically significant (P < 0.05) increased activity between day 7 and day 14 for pattern A, potentially indicating a continued effect on matrix remodeling. The early closure of all wounds implies that the rabbit ear model may not be valid for chronic wound studies.

Background: Most natural orifice transluminal endoscopic surgery (NOTES) procedures have been performed through the anterior stomach wall, based on the established safety of PEG placement. This approach does not afford mechanically efficient access to all anatomic areas of interest., Objective: To assess the utility of EUS in identifying safe alternate access sites for NOTES., Design: Nonsurvival animal experiment., Methods: Thirty-two EUS-guided access procedures were performed through the antrum, the posterior stomach wall, or the rectum of 12 pigs. Sixteen safe-access procedures (SAP) used sonographic guidance to achieve safe intraperitoneal access by avoiding extraluminal organs and vessels during the initial NOTES puncture. Sixteen unsafe-access procedures (UAP) evaluated potential complications of blind access by performing a standard NOTES puncture at sites adjacent to critical extraluminal structures identified by EUS. Access was achieved by using a similar technique for both SAPs and UAPs. Baseline and completion laparotomies were performed., Results: All 16 UAPs resulted in clinically relevant complications, such as liver laceration and iliac artery injury. In contrast, 13 SAPs were without complication. The 3 complications in the SAP group occurred with transrectal access and consisted of 2 minor complications and a small-bowel perforation., Conclusions: Blind NOTES access through the antrum, posterior stomach wall, and rectum could result in catastrophic complications. In contrast, EUS-guided access through these sites substantially reduced but did not completely eliminate this risk. EUS appears promising as an adjunct to NOTES access, particularly as more experience is gained in definitively excluding the presence of at-risk extraluminal structures.

Abdominal fascial closure after midline laparotomy can be time-consuming and inaccurate and is a common time for needle-stick injuries. The SuturTek 360 degrees Fascial Closure Device (FCD) is designed to provide a secure fascial closure while reducing the risk of needle-stick injury. To date, the accuracy and efficacy of the fascial closure obtained with this device have never been objectively determined. Ten pigs averaging 18 kg were killed and underwent a midline laparotomy. Idealized suture locations were premarked through the fascia. The animals were then randomly assigned to either a traditional suture closure or the FCD for fascial closure. Surgeons were instructed to place sutures through the idealized markers. Surgeons were then evaluated based on the time to close fascia and distance from the markers. Abdominal bursting pressures were obtained using a manometric balloon. Accuracy was also tested on an ex vivo model on which the participants were again asked to place stitches as close as possible to idealized marks, and absolute distance from the idealized location was calculated. The FCD resulted in a faster closure time when compared with traditional closure (5.9 +/- 0.6 vs 7.7 +/- 1.0 minute, P = .012), with a similar accuracy of placement from the idealized markers (1.5 +/- 1.4 mm vs 0.8 +/- 1.1 mm). Bursting pressures were similar between the 2 groups: 470 +/- 71 mm Hg for FCD versus 453 +/- 94 mm Hg for traditional closure ( P = .76). The FCD resulted in a faster fascial closure with similar accuracy and strength when compared with traditional open techniques. The potential reduction in serious needle-stick injuries warrants prospective trials.

Background: Efforts to develop improved endoscopic therapeutic methods for upper GI bleeding require an effective animal model., Objective: To develop a nonsurvival porcine model that simulates acute peptic ulcer bleeding., Design: Prospective animal (porcine) study., Setting: Animal laboratory., Interventions: A surgical seromyotomy was created along the external surface of the greater curvature of the stomach in anesthesized pigs. A submucosal plane was developed and the gastroepiploic bundle, in continuity, was placed adjacent to the mucosa, and the seromuscular tissues were re-approximated over the vascular bundle. By using EGD, a needle-knife with electrocautery was then used to incise the mucosal tissue overlying the vascular bundle. Standard endoscopic methods for bleeding control were then tested in this animal model., Main Outcome Measurements: To evaluate whether successful bleeding that simulates submucosal arterial bleeding from peptic ulcer disease could be achieved in a porcine animal model., Results: Successful simulation of active peptic ulcer bleeding was achieved with this nonsurvival porcine model in a total of 5 sequential pigs. Other porcine models for bleeding were tested and found to be unsatisfactory. Hemoclips and combination injection-thermal therapy were used to stop bleeding over Doppler-positive areas, with subsequent endoscopic nonimaging Doppler US probe examination of the ulcer bed revealing a negative Doppler signal., Limitations: This was an animal laboratory study. Further human studies would be ideal once any future endoscopic interventions are proven to be safe in animals., Conclusions: This active bleeding ulcer model can be used to develop future endoscopic therapies and for training purposes.

Background: Obtaining reliable closure of transvisceral defects currently limits natural orifice transluminal endoscopic surgery (NOTES). PEG tubes are potential means of managing NOTES gastrotomies., Objective: To determine the efficacy of PEG closure after NOTES., Design: An experimental animal study., Setting: A laboratory., Interventions: The pigs received gastric lavage with saline solution, chloramphenicol, or no lavage, and then underwent transgastric NOTES peritoneoscopy. Cultures were obtained by endoscopy during the surgery. A sterile foreign body was left in the peritoneal cavity. The gastrotomy was closed with a 20F PEG tube. The animals were observed for 14 days and underwent sterile laparotomy. Cultures of the foreign body and the peritoneal cavity were obtained., Main Outcome Measurements: Abscess rate, peritoneal quantitative cultures., Results: After 1 exclusion for anesthetic complications, 19 animals underwent NOTES; 18 (94.7%) survived the entire postoperative period. One animal died on postoperative day 2 after the PEG tube dislodged. At 14 days, 5 animals (27.8%) had intra-abdominal abscesses, 8 (44.4%) had positive peritoneal cultures, and 9 (50%) foreign bodies were contaminated on culture. Infectious complications were not altered by the type of gastric lavage or peritoneal bacterial inoculum introduced at the time of surgery., Limitation: An animal model., Conclusions: PEG closure of a NOTES gastrotomy is associated with subclinical intra-abdominal abscess formation and can result in death when the tube is dislodged during the early postoperative period. Preprocedural gastric lavage does not alter the intra-abdominal bacterial burden introduced at the time of surgery or subsequent infectious outcomes in the porcine model. These concerning findings necessitate additional studies to determine if porcine models are appropriate and applicable to human subjects in the NOTES setting.

Purpose: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an emerging technology that uses endoscopic instruments passed into the peritoneal cavity through hollow viscera to perform surgical procedures without the use of abdominal incisions. There are, however, limitations regarding the equipment available to simulate traditional surgery. The aim of this study was to determine the feasibility of a pure NOTES nephrectomy by using standard laparoscopic instruments through a modified transvaginal trocar., Materials and Methods: One 40-kg female swine underwent transgastric peritoneoscopy. Transgastric endoscopic visualization guided the introduction of a second transvaginal endoscope through a novel laparoscopic trocar/endoscopic overtube device. The retroflexed transgastric endoscope provided triangulated visualization as standard endoscopic instruments provided retraction, which allowed dissection of the kidney with standard laparoscopic instruments through our modified transvaginal trocar device. Each renal hilum, artery, vein, and ureter was dissected and divided with a transvaginal laparoscopic stapler., Results: Transgastric and transvaginal NOTES accesses were easily achieved, and bilateral nephrectomies were performed. Completion of peritoneoscopy revealed complete hemostasis and identification of ligated ureters and hilar vessels. Total operative time was 40 and 20 minutes for the right and left kidney, respectively. One kidney was captured with a laparoscopic retrieval sac and removed intact through the vaginal defect., Conclusions: Pure NOTES nephrectomies are technically feasible in the porcine model by using standard laparoscopic instruments. Survival studies are necessary to determine the long-term complications and physiologic implications of NOTES nephrectomy. The development of innovative NOTES access trocars may allow for an increased armamentarium of NOTES instruments.

Background: The use of intraoperative radiotherapy (IORT) in patients with resected pancreatic adenocarcinoma has not been clearly defined., Methods: The medical records of our first 22 patients receiving IORT for resected pancreatic adenocarcinoma (2001 to 2006) were reviewed and compared with the records of 27 consecutive patients not receiving IORT for resected pancreatic adenocarcinoma (2004 to 2006)., Results: There were no 30-day mortalities in either group, and complication rates were similar. Local recurrence occurred in 18% in the IORT group (median 14 months) and 12% in the no-IORT group (median 7 months). Distant recurrence occurred in 47% in the IORT group (median 11 months) and 32% in the no-IORT group (median 6.5 months). Median overall, stage-specific, and location-specific survival did not differ between the groups., Conclusions: Although limited in size and follow-up, our experience showed that complications, recurrence, and survival were not affected by IORT, but time to recurrence may be longer with IORT.

Background: Natural orifice translumenal endoscopic surgery (NOTES) allows access to the peritoneal cavity without skin incisions. Contamination of the peritoneal cavity by enteric contents may render NOTES more physiologically and immunologically invasive than previously thought. Measurement of interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) is a validated method to quantify surgical stress. The physiologic and immunologic impact of NOTES is unknown., Methods: A total of 37 swine underwent abdominal exploration via transgastric NOTES peritoneoscopy, laparoscopy (LX), laparotomy (OPEN), or sham surgery (CONTROL) and were allowed to survive. TNF-alpha, IL-1beta, and IL-6 plasma levels were determined at the start and completion of surgery, and at 1 hour, 2 days, and 14 days postoperatively., Results: At surgical completion, OPEN animals demonstrated higher TNF-alpha levels than all groups. TNF-alpha levels were similar for all groups at 1 hour and 2 days. NOTES animals had significantly reduced plasma levels of TNF-alpha than all other groups on postoperative days 7 and 14. Controlling for baseline cytokine variability, analysis was repeated using normalized data, which confirmed significantly reduced TNF-alpha levels for NOTES compared with all groups at 14 days. Subset analysis excluding LX and OPEN complications revealed lower NOTES TNF-alpha levels at 7 and 14 days compared with all groups. IL-1beta and IL-6 levels were undetectable in 66.8% and 70.5% of samples, respectively, without significant trends., Conclusions: Diagnostic NOTES peritoneoscopy demonstrated similar levels of systemic proinflammatory cytokine TNF-alpha compared with diagnostic laparoscopy and exploratory laparotomy in the immediate postoperative period despite gross intraperitoneal contamination. None of the surgical groups, however, produced a measurable, consistent trend in IL-1beta or IL-6. Consistently reduced levels of TNF-alpha in NOTES animals in the late postoperative period indicates an immunomodulatory effect of the NOTES surgical technique not present in laparoscopy or laparotomy.

A study was carried out to determine whether the location of the inferior gluteal nerve could be reliably predicted using external anatomy or vascular imaging. This study was motivated by our group's development of an electrical stimulation system to provide direct gluteal stimulation in paralyzed individuals, in particular those with spinal cord injury (SCI). Pressure ulcers are a common complication for many individuals with reduced mobility. Numerous approaches have been employed to treat and prevent pressure ulcers; however no procedure or nursing care regimen has been successful in eradicating them completely. Our group seeks to prevent skin breakdown in susceptible patients by direct electrical stimulation of the paralyzed gluteal muscle, leading to improved circulation and increased muscle mass (hypertrophy) in the treated area. Currently, percutaneous electrodes are placed through an extensive probing process to select the motor point of the target muscle. We examined 15 cadaver gluteal regions to identify the relationship between the internal anatomy of the inferior gluteal artery and nerve as well as the relationship to external anatomic landmarks. The cadavers displayed variability with regard to the morphology of the branches of both nerve and artery. Furthermore, there did not appear to be any relationship between the relative positions of the nerve and artery. However, the potential target area of the proximal origin of the inferior gluteal nerve could reliably be predicted from the external bony anatomy of the lower pelvis.

Background: The NDO Plicator is a device developed for endoscopic treatment of gastroesophageal reflux disease (GERD) by approximation of tissues together with a double-pledgeted U-stitch. It was theorized that this device may facilitate transgastric natural orifice translumenal endoscopic surgery (NOTES) because closure of the transgastric defect remains a key component for advancement of this new technology., Methods: A standardized 12-mm gastrotomy was created endoscopically in four pigs using a combination of needle-knife cautery and balloon dilation. As the endoscope was removed, a Savary soft-tipped wire was introduced into the stomach, and the NDO Plicator was subsequently advanced over the wire. Each defect was identified, and the device was positioned. If necessary, the Plicator's tissue grasper was used to hold the superior aspect of the gastrotomy and bring the opposed borders of the defect within the jaws of the device. The device was fired three times, leaving three pledgeted suture bundles to close the gastric defect. After closure, each animal was explored, and the integrity of the closure was assessed. The animals underwent in vivo contrast fluoroscopy and ex vivo burst pressure testing studies for assessment of leakage at the closure site., Results: The first animal was used to test feasibility, refine techniques, and develop a standard procedure. All of the next three animals studied showed complete sealing of the gastrotomy site without evidence of contrast extravasation on multiplanar fluoroscopic imaging. Each stomach was excised, submerged in water, and subjected to a pressurized air leak test. No leaks were noted until pressures exceeded 55 mmHg., Conclusion: This study supports the use of the NDO Plicator for closure of standardized gastric defects in a porcine model. In addition to closing NOTES gastrotomies, the NDO Plicator may be a particularly useful tool for obtaining complete closure of gastric perforations and anastomotic leaks, and for performing stomal reduction after gastric bypass procedures. The mechanical properties of a closure are not the only factor determining whether a leak will develop. Tissue opposition, ischemia, and tension are important factors that are not easily or reliably measured. The physiologic relevance of gastric bursting pressure is not known. Therefore, corollary animal studies with longer-term evaluation are necessary before research proceeds to clinical trials.

Obtaining endolumenal closure of hollow visceral defects may complement conventional, incision-based, surgical alternatives and benefit the experimental field of natural orifice translumenal endoscopic surgery (NOTES). Endoscopic tissue plicating devices (TPD) represent a promising closure technology; however, the long-term integrity of resultant closures is uncertain. Swine (n=10) underwent survival transgastric NOTES peritoneoscopy procedures with TPD gastrotomy closure while device performance and closure integrity were evaluated. Following uncomplicated procedures, no animals revealed leakage on upper gastrointestinal contrast fluoroscopy immediately following closure and on postoperative days 2 and 7. Necropsy performed on the 14th postoperative day revealed a subclinical colonic injury for one animal; the remaining nine animals had no complications. Gastric burst testing revealed the strength of closure was comparable to that of nonsurgical control stomachs (85.1 vs. 85.3 mm Hg, p=0.98). For six of nine (66%) TPD animals, bursting occurred remote to the closure site in nonsurgical tissue, indicating that closure strength equaled that of native tissue. Endoscopic TPD closure of standardized NOTES gastric defects results in strong, leak-proof closure; however, injuries can occur. These findings support evaluation of TPD closure in human trials involving noncontrolled gastric defects.

Background: The ideal technique for the use of AlloDerm (LifeCell Corp) in complicated ventral hernia repair has not been defined. The expense of these products mandates careful evaluation to justify their widespread use. We compared two techniques of fascial bridging versus fascial reinforcement repair with regard to their longterm recurrence rates using AlloDerm., Study Design: We retrospectively studied patients with abdominal defects repaired with AlloDerm at our institution., Results: Thirty-seven patients with abdominal wall repairs using AlloDerm were identified between January 2004 and December 2005. Eleven patients underwent bridged fascial repair; 26 patients had reinforced fascial repair. There was no statistical significance between the 2 groups in terms of average age (57 versus 52 years), body mass index (35 versus 29 kg/m(2)), American Society of Anesthesiologists score (2.9 versus 2.5), or number of earlier abdominal operations (3.4 versus 3.5). The average sizes of AlloDerm used were 175 cm(2) for bridged and 89 cm(2) for reinforced repair (p=0.005). In patients with reinforced closure, primary repair was achieved with lateral component separation in 22 of 26 patients. Mean followup was 21.4 months (range 15 to 36 months). In the bridged group, 1 patient died on postoperative day 20. Of the remaining 10 patients, 8 patients (80%) developed recurrences. Seven patients required reoperation, but one patient refused repair. In the reinforced group, four patients were lost to followup and two patients died. Four of the remaining 20 patients (20%) developed recurrences that required repair; this was significantly different from the recurrence rate in the bridged group (p=0.009)., Conclusions: This study demonstrated that the method in which AlloDerm is used in abdominal wall reconstruction has a significant impact on recurrence rates. Based on our findings, AlloDerm should be used only as a reinforcement after primary fascial reappoximation.

Background: The ideal surgical treatment for complicated ventral hernias remains elusive. Traditional component separation provides local advancement of native tissue for tension-free closure without prosthetic materials. This technique requires an extensive subcutaneous dissection, with the division of perforating vessels predisposing to skin flap necrosis and complicated wound infections. The laparoscopic separation of components provides a minimally invasive alternative to open techniques, while eliminating the potential space and subsequent complications of large skin flaps. We report our initial experience with a minimally invasive component separation with early postoperative outcomes., Methods: We retrospectively reviewed the medical records of all patients who underwent a minimally invasive component separation for abdominal wall reconstruction during the resection of an infected prosthetic. Pertinent details included baseline demographics, reason for contamination, operative technique and details, postoperative morbidity, mortality, and recurrence rates., Results: Between August 2006 and January 2007, seven patients were identified who underwent a laparoscopic component separation. There were four males and three females, with a mean age of 54 years (range 34-84), mean American Society of Anesthesiologist (ASA) score of 3.2 (range 3-4), and mean body mass index (BMI) of 37 kg/m2 (range 30-45). The reason for contamination included exposed non-healing mesh (6) and contaminated fluid collection around the mesh (1). Residual defect size following the removal of all prosthetics was 338 cm2 (range 187-450). The mean operative time was 185 min (range 155-220). Laparoscopic component separation enabled tension-free primary fascial reapproximation in all patients. Three postoperative complications occurred, including superficial surgical site infection (1), respiratory failure (1), and hematoma (1). There was no mortality in this series. During an average follow-up period of 4.5 months, no recurrences were identified., Conclusions: This study shows that a minimally invasive component separation is feasible and can result in minimal postoperative wound morbidity in these complex patients. Long-term follow-up is necessary to evaluate the outcomes with respect to recurrence rates.

Background: The ideal surgical treatment for complicated ventral hernias remains elusive. Traditional component separation provides local advancement of native tissue for tension-free closure without prosthetic materials. This technique requires an extensive subcutaneous dissection with division of perforating vessels predisposing to skin-flap necrosis and complicated wound infections. A minimally invasive component separation may decrease wound complication rates; however, the adequacy of the myofascial advancement has not been studied., Methods: Five 25-kg pigs underwent bilateral laparoscopic component separation. A 10-mm incision was made lateral to the rectus abdominus muscle. The external oblique fascia was incised, and a dissecting balloon was inflated between the internal and external oblique muscles. Two additional ports were placed in the intermuscular space. The external oblique was incised from the costal margin to the inguinal ligament. The maximal abdominal wall advancement was recorded. A formal open-component separation was performed and maximal advancement 5 cm superior and 5 cm inferior to the umbilicus was recorded for comparison. Groups were compared using standard statistical analysis., Results: The laparoscopic component separation was completed successfully in all animals, with a mean of 22 min/side. Laparoscopic component separation yielded 3.9 cm (SD 1.1) of fascial advancement above the umbilicus, whereas 4.4 cm (1.2) was obtained after open release (P = .24). Below the umbilicus, laparoscopic release achieved 5.0 cm (1.0) of advancement, whereas 5.8 cm (1.2) was gained after open release (P = .13)., Comments: The minimally invasive component separation achieved an average of 86% of the myofascial advancement compared with a formal open release. The laparoscopic approach does not require extensive subcutaneous dissection and might theoretically result in a decreased incidence or decreased complexity of postoperative wound infections or skin-flap necrosis. Based on our preliminary data in this porcine model, further comparative studies of laparoscopic versus open component separation in complex ventral hernia repair is warranted to evaluate postoperative morbidity and long-term hernia recurrence rates.

Unlabelled: Dislodged percutaneous endoscopic gastrostomy (PEG) tubes occur commonly and may require urgent surgical intervention in a susceptible patient population. Natural orifice translumenal endoscopic surgery (NOTES) may facilitate PEG rescue and avoid the morbidity associated with contemporary surgical techniques. We report a case of a dislodged PEG tube in the early post-operative period with evidence of incomplete gastrocutaneous tract formation and intra-abdominal leakage. Bedside transgastric NOTES exploration facilitated peritoneoscopy, evacuation of intra-abdominal fluid, and re-establishment of the PEG tube through the original gastrotomy tract. Tube feeds were resumed and postoperative contrast fluoroscopy demonstrated no intra-abdominal leakage from the replaced PEG tube. No postoperative complications related to the NOTES procedure were noted at 30 days of follow-up. PEG rescue represents a unique, practical, and empowering application of the burgeoning experience of NOTES., Electronic Supplementary Material: The online version of this article (doi: 10.1007/s464-007-9361-2) contains supplementary material, which is available to authorized users.

Background: Natural orifice translumenal endoscopic surgery (NOTES) provides surgical access to the peritoneal cavity without skin incisions. The NOTES procedure requires pneumoperitoneum for visualization and manipulation of abdominal organs, similar to laparoscopy. Accurate measurement of the pneumoperitoneum pressure is essential to avoid potentially deleterious effects of intraabdominal compartment syndrome. A reliable method for monitoring pneumoperitoneum pressures during NOTES has not been identified. This study evaluated several methods of monitoring intraabdominal pressures with a standard gastroscope during NOTES., Methods: Four female pigs (25 kg) were sedated, and a single-channel gastroscope was passed transgastrically into the peritoneal cavity. Pneumoperitoneum was achieved via a pressure insufflator through a percutaneous, intraperitoneal 14-gauge catheter. Three other pressures were recorded via separate catheters. First, a 14-gauge percutaneous catheter passed intraperitoneally measured true intraabdominal pressure. Second, a 14-gauge tube attached to the endoscope was used to measure endoscope tip pressure. The third pressure transducer was connected directly to the accessory channel of the endoscope. The abdomen was insufflated to a range of pressures (10-30 mmHg), and simultaneous pressures were recorded from all three pressure sensors., Results: Pressure correlation curves were developed for all animals across all intraperitoneal pressures (mean error, -4.25 to -1 mmHg). Endoscope tip pressures correlated with biopsy channel pressures (R2 = 0.99). Biopsy channel and endoscope tip pressures fit a least-squares linear model to predict actual intraabdominal pressure (R = 0.99 for both). Both scope tip and biopsy channel port pressures were strongly correlative with true intraabdominal pressures (R2 = 0.98 and R2 = 0.99, respectively)., Conclusion: This study demonstrates that monitoring pressure through an endoscope is reliable and predictive of true intraabdominal pressure. Gastroscope pressure monitoring is a useful adjunct to NOTES. Future NOTES procedures should incorporate continuous intraabdominal pressure monitoring to avoid the potentially deleterious effects of pneumoperitoneum during NOTES. This can be achieved by the integration of pressure-monitoring capabilities into gastroscopes.

Background: Autopsy studies confirm that many intensive care unit (ICU) patients die from unrecognized sources of abdominal sepsis or ischemia. Computed tomography (CT) scans can be of limited use for these diagnoses and difficult to obtain in critically ill patients who require significant support for transport. Bedside laparoscopy has been described but still is cumbersome to perform. Bedside flexible endoscopy as a diagnostic tool or for placement of gastrostomy tubes is a standard ICU procedure. Natural orifice transluminal endoscopic surgery (NOTES) can provide access to the peritoneal cavity as a bedside procedure and may decrease the number of patients with unrecognized intra-abdominal catastrophic events., Methods: Pigs were anesthetized and peritoneal access with the flexible endoscope was obtained using a guidewire, needle knife cautery, and balloon dilatation. The transgastric endoscope was used to explore all quadrants of the abdominal cavity. The small bowel was visualized to complete the exploration. The transgastric access location was then managed with the use of a gastrostomy tube. The animals were euthanized and analyzed., Results: Eight pigs were studied and complete abdominal exploration, including diaphragm visualization, was possible in all cases. Endoscopy-guided biopsies were performed, adhesions lysed, and the gallbladder successfully drained percutaneously. The small bowel was run successfully with percutaneous needlescopic suture graspers., Conclusions: These animal studies support the concept that NOTES, with management of the gastric opening with a gastrostomy tube, may be another approach for finding unrecognized sources of abdominal sepsis or mesenteric ischemia in difficult ICU patients. These encouraging results warrant a prospective human trial to assess safety and efficacy.

Background: Cystic pancreatic neoplasms encompass a range of benign to malignant disease. Recommendations for surgical management vary., Methods: Records of patients with cystic pancreatic neoplasms from January 1996 through December 2005 were retrospectively reviewed., Results: Sixty resections were performed for 16 serous cystic neoplasms, 7 mucinous cystic neoplasms (MCNs), and 37 intraductal papillary mucinous neoplasms (IPMNs). Twenty-five percent (15/60) of neoplasms contained invasive cancer. Patients with MCN or IPMN invasive neoplasms experienced significantly diminished overall 5-year survival compared to patients with IPMN carcinoma in situ neoplasms and to patients with MCN or IPMN adenoma/borderline neoplasms (22% vs. 73% vs. 94%, P = .004)., Conclusions: Given the poor long-term survival of patients with cystic pancreatic neoplasms containing invasive cancer and the current difficulty to preoperatively distinguish among the various types of lesions in a reliable manner, our data support an aggressive surgical approach to the management of cystic pancreatic neoplasms.

Background: Up to 50% of the patients in the intensive care unit (ICU) require mechanical ventilation, with 20% requiring the use of a ventilator for more than 7 days. More than 40% of this time is spent weaning the patient from mechanical ventilation. Failure to wean from mechanical ventilation can in part be attributable to rapid onset of diaphragm atrophy, barotrauma, posterior lobe atelectasis, and impaired hemodynamics, which are normally improved by maintaining a more natural negative chest pressure. The authors have previously shown that laparoscopic implantation of a diaphragm pacing system benefits selected patients. They now propose that an acute ventilator assist with interventional neurostimulation of the diaphragm in the ICU is feasible and could facilitate the weaning of ICU patients from mechanical ventilation. Natural orifice transluminal endoscopic surgery (NOTES) has the potential to expand the benefits of the diaphragm pacing system to this acute patient population by allowing it to be performed at the bedside similarly to insertion of the common gastrostomy tube. This study evaluates the feasibility of this approach in a porcine model., Methods: Pigs were anesthetized, and peritoneal access with the flexible endoscope was obtained using a guidewire, needle knife cautery, and balloon dilation. The diaphragm was mapped using a novel endoscopic electrostimulation catheter to locate the motor point (where stimulation provides complete contraction of the diaphragm). An intramuscular electrode then was placed at the motor point with a percutaneous needle. The gastrotomy was managed with a gastrostomy tube., Results: Four pigs were studied, and the endoscopic mapping instrument was able to map the diaphragm to identify the motor point. In one animal, a percutaneous electrode was placed into the motor point under transgastric endoscopic visualization, and the diaphragm could be paced in conjunction with mechanical ventilation., Conclusions: These animal studies demonstrate the feasibility of transgastric mapping of the diaphragm and implantation of a percutaneous electrode for therapeutic diaphragmatic stimulation.

Access to the abdominal cavity is required for diagnostic and therapeutic endeavors for a variety of medical and surgical diseases. Historically, abdominal access has required a formal laparotomy to provide adequate exposure. Natural orifice transluminal endoscopic surgery (NOTES) is an emerging experimental alternative to conventional surgery that eliminates abdominal incisions and incision-related complications by combining endoscopic and laparoscopic techniques to diagnose and treat abdominal pathology. During NOTES, commercially available flexible video endoscopes are used to create a controlled transvisceral incision via natural orifice access to enter the peritoneal cavity. Common incision-related complications such as wound infections, incisional hernias, postoperative pain, aesthetic disdain, and adhesions could be minimized or eliminated by NOTES. NOTES has evolved from more than 2 centuries of technological innovations and continued growth in the field of surgical endoscopy. Innovative surgical endoscopists have slowly developed means to surpass the constraints of the gastrointestinal lumen by using a flexible endoscope. The future of surgical endoscopy may be the shared entity of NOTES, which further integrates endoscopy, gastroenterology, and minimally invasive and general surgery. Although the promise of NOTES is electrifying to surgeons and endoscopists, several key issues need to be characterized prior to the incorporation of NOTES into routine practice. This article reviews the status, contemporary body of literature, limitations, and potential future implications accompanying the development of NOTES.

The National Institute of Mental Health initiated the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program to evaluate the effectiveness of antipsychotic drugs in typical settings and populations so that the study results will be maximally useful in routine clinical situations. The CATIE schizophrenia trial blends features of efficacy studies and large, simple trials to create a pragmatic trial that will provide extensive information about antipsychotic drug effectiveness over at least 18 months. The protocol allows for subjects who receive a study drug that is not effective to receive subsequent treatments within the context of the study. Medication dosages are adjusted within a defined range according to clinical judgment. The primary outcome is all-cause treatment discontinuation because it represents an important clinical endpoint that reflects both clinician and patient judgments about efficacy and tolerability. Secondary outcomes include symptoms, side effects, neurocognitive functioning, and cost-effectiveness. Approximately 50 clinical sites across the United States are seeking to enroll a total of 1,500 persons with schizophrenia. Phase 1 is a double-blinded randomized clinical trial comparing treatment with the second generation antipsychotics olanzapine, quetiapine, risperidone, and ziprasidone to perphenazine, a midpotency first generation antipsychotic. If the initially assigned medication is not effective, subjects may choose one of the following phase 2 trials: (1) randomization to open-label clozapine or a double-blinded second generation drug that was available but not assigned in phase 1; or (2) double-blinded randomization to ziprasidone or another second generation drug that was available but not assigned in phase 1. If the phase 2 study drug is discontinued, subjects may enter phase 3, in which clinicians help subjects select an open-label treatment based on individuals' experiences in phases 1 and 2.