136 results on '"X. Serra-Aracil"'
Search Results
52. Accreditation of specialized surgical units in general and digestive surgery: A step forward by the AEC for quality improvement and subspecialized Fellowship training.
- Author
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Millan M, Targarona E, García-Granero E, and Serra-Aracil X
- Subjects
- Accreditation, Education, Medical, Graduate, Humans, Quality Improvement, Digestive System Surgical Procedures, Fellowships and Scholarships
- Abstract
At present, in daily practice, the Departments of Surgery in most hospitals in Spain are organized into "Specialized Surgical Units", including specific structure, human resources, organization, teaching and research in the different subspecialties included in General and Digestive Surgery (GDS). Furthermore, there are also several specialized "fellowship-like", training programs in the different subspecialties already working in some of these "Specialized Surgical Units", although not officially financed. However, until now there was no model for accreditation or recognition of these Units or fellowship programs. The AEC has designed a regulation for the accreditation of Specialized Surgical Units in GDS, that will also serve as a model to define subspecialty training in these areas. The accreditation process, and with it, the process of quality improvement, includes different quality indicators, including unit structure, process quality, and result indicators., (Copyright © 2021 AEC. Published by Elsevier España, S.L.U. All rights reserved.)
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- 2022
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53. Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.
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Mora-López L, Ruiz-Edo N, Estrada-Ferrer O, Piñana-Campón ML, Labró-Ciurans M, Escuder-Perez J, Sales-Mallafré R, Rebasa-Cladera P, Navarro-Soto S, and Serra-Aracil X
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- Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Diverticulitis, Colonic diagnosis, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Tomography, X-Ray Computed, Young Adult, Ambulatory Care methods, Disease Management, Diverticulitis, Colonic therapy, Outpatients
- Abstract
Objective: Mild AD can be treated safely and effectively on an outpatient basis without antibiotics., Summary of Background Data: In recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective., Methods: A Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms., Results: Four hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18)., Conclusions: Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment., Trial Registration: ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75)., Competing Interests: The authors declare no conflict of interests. The authors report no funding and conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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54. T1 Rectal Adenocarcinoma: a Different Way to Measure Tumoral Invasion Based on the Healthy Residual Submucosa with Its Prognosis and Therapeutic Implications.
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Casalots A, Serra-Aracil X, Mora-Lopez L, Garcia-Nalda A, Pericay C, Ferreres JC, and Navarro-Soto S
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- Humans, Neoplasm Invasiveness, Prognosis, Adenocarcinoma surgery, Rectal Neoplasms surgery, Transanal Endoscopic Microsurgery
- Abstract
Background: Surgical treatment of early rectal cancer T1 is either local excision or total mesorectal excision. The choice of surgery is based on the risk of metastatic lymph node involvement. The most important factor to consider is the degree of submucosal invasion. We present a different way to measure tumoral invasion derived from the measurement of the healthy residual submucosa with its prognosis and therapeutic implications METHODS: Observational study of tumor submucosal invasion in patients undergoing transanal endoscopic microsurgery was conducted. Parameters evaluated are submucosal invasion, measuring the healthy residual submucosa at the point of maximum invasion; macroscopic morphology of the tumor; presence of muscularis mucosa, muscularis propria, and measurement of submucosa in the tumor area and the healthy area. The classification proposed is compared with the ones previously published., Results: Eighty consecutive patients diagnosed with T1 rectal cancer underwent transanal endoscopic microsurgery. Seventeen tumors (21.3%) were polypoid. En bloc resection was achieved in 77 (96.3%). The muscularis mucosa was present in 28 (35%), and the muscularis propria in 77 (96.3%) (p < 0.001). The healthy residual submucosa in the tumor area measured 2,343 ± 1,869 μm. Agreement was moderate with the Kikuchi classification (kappa 0.58) and very good with the Kudo classification (kappa 0.87)., Conclusions: We describe a method for measuring submucosal invasion in T1 rectal cancer which does not depend on the morphology of the lesion or on the presence of the muscularis mucosa. It can be applied to all T1 classifications of the digestive tract in which the muscularis propria is present., (© 2021. The Society for Surgery of the Alimentary Tract.)
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- 2021
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55. Management of intra- and postoperative complications during TEM/TAMIS procedures: a systematic review.
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Serra-Aracil X, Badia-Closa J, Pallisera-Lloveras A, Mora-López L, Serra-Pla S, Garcia-Nalda A, and Navarro-Soto S
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- Female, Humans, Postoperative Complications epidemiology, Treatment Outcome, Rectal Neoplasms, Transanal Endoscopic Microsurgery, Transanal Endoscopic Surgery
- Abstract
Introduction: Transanal endoscopic microsurgery (TEM) is a safe procedure and the rates of intra- and postoperative complications are low. The information in the literature on the management of these complications is limited, and so their importance may be either under- or overestimated (which may in turn lead to under- or overtreatment). The present article reviews the most relevant series of TEM procedures and their complications and describes various approaches to their management., Evidence Acquisition: A systematic review of the literature, including TEM series of more than 150 cases each. We analyzed the population characteristics, surgical variables and intraoperative and postoperative complications., Evidence Synthesis: A total of 1043 records were found. After review, 1031 were excluded. The review therefore includes 12 independent cohorts of TEM procedures with a total of 4395 patients. The rate of perforation into the peritoneal cavity was 5.1%, and conversion to abdominal approach was required in 0.8% of cases. The most frequent complications were acute urinary retention (AUR, 4.9%) and rectal bleeding (2.2%). Less common complications included abscesses (0.99%) and rectovaginal fistula (0.62%). Mortality rates were low, with a mean value of 0.29%., Conclusions: Awareness and knowledge of TEM complications and their management can play an important role in their treatment and patient safety. Here, we present a review of the most important TEM series and their complication rates and describe various approaches to their management.
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- 2021
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56. Preoperative Diagnostic Uncertainty in T2-T3 Rectal Adenomas and T1-T2 Adenocarcinomas and a Therapeutic Dilemma: Transanal Endoscopic Surgery, or Total Mesorectal Excision?
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Serra-Aracil X, Montes N, Mora-Lopez L, Serracant A, Pericay C, Rebasa P, and Navarro-Soto S
- Abstract
Background: Endorectal ultrasound and rectal magnetic resonance are sometimes unable to differentiate between stages T2 and T3 in rectal adenomas that are possible adenocarcinomas, or between stages T1 and T2 in rectal adenocarcinomas. These cases of diagnostic uncertainty raise a therapeutic dilemma: transanal endoscopic surgery (TES) or total mesorectal excision (TME)?, Methods: An observational study of a cohort of 803 patients who underwent TES from 2004 to 2021. Patients operated on for adenoma (group I) and low-grade T1 adenocarcinoma (group II) were included. The variables related to uncertain diagnosis, and to the definitive pathological diagnosis of adenocarcinoma stage higher than T1, were analyzed., Results: A total of 638 patients were included. Group I comprised 529 patients, 113 (21.4%) with uncertain diagnosis. Seventeen (15%) eventually had a pathological diagnosis of adenocarcinoma higher than T1. However, the variable diagnostic uncertainty was a risk factor for adenocarcinoma above T1 (OR 2.3, 95% CI 1.1-4.7). Group II included 109 patients, eight with uncertain diagnosis (7.3%). Two patients presented a definitive pathological diagnosis of adenocarcinoma above T1., Conclusions: On the strength of these data, we recommend TES as the initial indication in cases of diagnostic uncertainty. Multicenter studies with larger samples for both groups should now be performed to further assess this strategy of initiating treatment with TES.
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- 2021
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57. How to Learn a Complex Endoscopic Procedure: Knots in Transanal Endoscopic Surgery: Different Skill Among Surgeons.
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Serra-Aracil X, Gracia-Roman R, Badía-Closa J, Mora-Lopez L, Pallisera-Lloveras A, Serra-Pla S, Garcia-Nalda A, and Navarro-Soto S
- Subjects
- Cross-Sectional Studies, Humans, Suture Techniques, Sutures, Surgeons, Transanal Endoscopic Surgery
- Abstract
Purpose: The intrarectal suture is considered a high technically complex procedure. The study's objectives were to assess the feasibility of making an intrarectal knot, through an in vitro study and assessing whether the video tutorial facilitates learning., Materials and Methods: A detailed description of the technique. A comparative observational cross-sectional study in surgeons with no previous experience in intrarectal knots., Results: Twenty-one of these 32 participants passed the intrarectal knot test without video tutorial (T1) (65.6%), and 26 (81.2%) after the video tutorial (T2) (P=0.26). The mean time taken to tie the knot fell from 74 seconds (SD=46) in T1 to 41 seconds (SD=41) in T2 (P<0.001). At T1, 26 participants (81.3%) described the technique as difficult, but only 7 (21.9%) at T2 (P<0.001)., Conclusions: Performing the intrarectal knot suture is feasible. Despite the technical difficulty, the video tutorial is sufficient for surgeons to learn the technique., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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58. Minimal invasive surgery for left colectomy adapted to the COVID-19 pandemic: laparoscopic intracorporeal resection and anastomosis, a 'don't touch the bowel' technique.
- Author
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Serra-Aracil X, Mora-Lopez L, Gomez-Torres I, Pallisera-Lloveras A, Serra-Pla S, Serracant A, Garcia-Nalda A, Pino-Perez O, and Navarro-Soto S
- Subjects
- Aged, Aged, 80 and over, Anastomosis, Surgical methods, COVID-19 epidemiology, COVID-19 transmission, Female, Humans, Length of Stay, Male, Middle Aged, Operative Time, COVID-19 prevention & control, Colectomy methods, Colonic Diseases surgery, Infectious Disease Transmission, Patient-to-Professional prevention & control, Laparoscopy methods
- Abstract
Aim: The COVID-19 pandemic has forced surgeons to adapt their standard procedures. The modifications introduced are designed to favour minimally invasive surgery. The positive results obtained with intracorporeal resection and anastomosis in the right colon and rectum prompt us to adapt these procedures to the left colon. We describe a 'don't touch the bowel' technique and outline the benefits to patients of the use of less surgically aggressive techniques and also to surgeons in terms of the lower emission of aerosols that might transmit the COVID-19 infection., Methods: This was an observational study of intracorporeal resection and anastomosis in left colectomy. We describe the technical details of intracorporeal resection, end-to-end stapled anastomosis and extraction of the specimen through mini-laparotomy in the ideal location., Results: We present preliminary results of 17 patients with left-sided colonic pathologies, 15 neoplasia and two diverticular disease, who underwent four left hemicolectomies, six sigmoidectomies and seven high anterior resections. Median operating time was 186 min (range 120-280). No patient required conversion to extracorporeal laparoscopy or open surgery. Median hospital stay was 4.7 days (range 3-12 days). There was one case of anastomotic leak managed with conservative treatment., Conclusion: Intracorporeal resection and end-to-end anastomosis with the possibility of extraction of the specimen by a mini-laparotomy in the ideal location may present benefits and also adapts well to the conditions imposed by the COVID-19 pandemic. Future comparative studies are needed to demonstrate these benefits with respect to extracorporeal anastomosis., (© 2021 The Association of Coloproctology of Great Britain and Ireland.)
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- 2021
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59. Is there the same requirement to obtain the PhD degree in all the departments of surgery of the Spanish universities?
- Author
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Serra-Aracil X, Armengol Carrasco M, Morote Robles J, Espin Basany E, Amat-Lefort N, Serra-Gómez Á, and Navarro-Soto S
- Abstract
Introduction: The doctorate is the third cycle of official university studies, which, through the defense of the doctoral thesis leads to the acquisition of the title of doctor or PhD from the Anglo-Saxon countries. Royal Decree law 99/2011 regulates doctoral programs, with a wide margin on quality requirements. The objective of this study is to find out if there is this variation in the requirements of the doctorate programs of the different departments of surgery of the Spanish public universities and to establish a quality scale., Methods: Cross-sectional observational study from 2/22/2021 to 3/3/2021, through a survey sent electronically to the professors of the departments of surgery., Results: Thirty-five departments of surgery were consulted, obtaining a response in 29 of them (82.9%). The observed variation regarding requirements has been basically in the quality of the research project, in fact in 25 (86.2%) there are no regulations on this. When it is presented in the form of a compendium of articles, these are required to be original in 15 (51.7%). Regarding the position as author, the doctoral student must be the preferred author, at least in 2 articles in 14 (48.4%) of the programs. In 14 departments (48.4%) there are no regulations on the position of the articles and quartiles of journals. When scoring the different programs according to their requirements, the variability is high, ranging between 2 and 19 points. Funding for the development of the doctorate is meager., Conclusions: There is a wide variability in the requirement of doctoral programs. Homogeneous levels of demand must be defined to promote and protect higher-level doctorates., (Copyright © 2021 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2021
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60. Accreditation of specialized surgical units in general and digestive surgery: A step forward by the AEC for quality improvement and subspecialized Fellowship training.
- Author
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Millan M, Targarona E, García-Granero E, and Serra-Aracil X
- Abstract
At present, in daily practice, the Departments of Surgery in most hospitals in Spain are organized into "Specialized Surgical Units", including specific structure, human resources, organization, teaching and research in the different subspecialties included in General and Digestive Surgery (GDS). Furthermore, there are also several specialized "fellowship-like", training programs in the different subspecialties already working in some of these "Specialized Surgical Units", although not officially financed. However, until now there was no model for accreditation or recognition of these Units or fellowship programs. The AEC has designed a regulation for the accreditation of Specialized Surgical Units in GDS, that will also serve as a model to define subspecialty training in these areas. The accreditation process, and with it, the process of quality improvement, includes different quality indicators, including unit structure, process quality, and result indicators., (Copyright © 2021 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
61. Transanal Endoscopic Microsurgery: An Alternative Perineal Approach to Treat Rectal Prolapse: A Video Vignette.
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Pallisera-Lloveras A, Arruabarrena-Oyarbide A, Mora-López L, Serra-Pla S, Serracant-Barrera A, García-Nalda A, Navarro-Soto S, and Serra-Aracil X
- Subjects
- Humans, Male, Rectum, Treatment Outcome, Rectal Prolapse surgery, Transanal Endoscopic Microsurgery, Transanal Endoscopic Surgery
- Abstract
Purpose: Laparoscopic ventral rectopexy is the most favored surgical treatment for rectal prolapse. Perineal approaches are recommended for frail patients and those with major comorbidities, and in young men to avoid genitourinary disorders. There are very few descriptions in the literature of transanal endoscopic surgery to treat complete rectal prolapse. The aim of this article is to describe our experience with this technique., Patients and Methods: Patients undergoing transanal endoscopic surgery for rectal prolapse repair between 2010 and 2019 were recruited for the study. Preoperative, surgical, and postoperative variables were recorded. Surgical technique, 30-day morbidity and follow-up are described., Results: Five patients have been included. The postoperative period was uneventful and all patients were discharged in 48 hours without complications. All showed improved symptoms at 1-year control, and none presented recurrence in a mean follow-up period of 6 years., Conclusions: The transanal endoscopic procedure allows improved endoscopic vision, and the reconstruction is performed transpelvically by fixing the anastomosis suture to the pelvic wall to prevent recurrence. Therefore, we think it is a valid alternative to other perineal procedures in patients in whom abdominal surgery is contraindicated., Competing Interests: The author declares no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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62. Urinary catheter in colorectal surgery: current practices and improvements in order to allow prompt removal. A cross-sectional study.
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Serra-Aracil X, DomÍnguez A, Mora-LÓpez L, Hidalgo J, Pallisera-Lloveras A, Serra-Pla S, Badia-Closa J, Garcia-Nalda A, and Navarro-Soto S
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- Cross-Sectional Studies, Humans, Length of Stay, Urinary Catheters, Colorectal Surgery, Digestive System Surgical Procedures
- Abstract
Background: Despite the publication of the guidelines for enhanced recovery after surgery (ERAS), attitudes to urinary catheter (UC) management vary widely in colorectal surgery. The aim of the present study was to define current practices in UC management in colorectal surgery., Methods: Cross-sectional observational study carried out in March-April 2019, based on the responses to a survey administered to public hospitals in Catalonia. Respondents were asked about their observance of ERAS programs, the percentage of laparoscopic procedures performed, and the time of UC withdrawal in surgery of the colon and rectum., Results: Forty-three of 45 hospitals contacted eventually responded (95.6%). As two hospitals reported that they did not perform colorectal surgery, the study is based on the results from 41 centers. Thirty-five (85.4%) reported following ERAS programs; 30 (73.2%) have coloproctology units, and 39 (95.1%) perform more than 70% of colorectal surgeries by laparoscopy. In colon surgery, 27 (65.9%) remove the UC at 24 h, and 12 (29.3%) on day 2 or day 3. In rectal surgery, 17 (58.6%) remove the UC on day 2-3., Conclusions: Management of UC in colon and rectal surgery varies widely. There is clearly room for improvement in UC management, but needs to be thoroughly assessed in randomized multicenter studies.
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- 2021
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63. Completion Surgery in Unfavorable Rectal Cancer after Transanal Endoscopic Microsurgery: Does It Achieve Satisfactory Sphincter Preservation, Quality of Total Mesorectal Excision Specimen, and Long-term Oncological Outcomes?
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Serra-Aracil X, Galvez Saldaña A, Mora-Lopez LL, Montes N, Pallisera-Lloveras A, Serra-Pla S, Pericay C, and Navarro-Soto S
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- Adenocarcinoma pathology, Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Margins of Excision, Middle Aged, Neoplasm Recurrence, Local epidemiology, Neoplasm Recurrence, Local prevention & control, Rectal Neoplasms pathology, Retrospective Studies, Treatment Outcome, Adenocarcinoma surgery, Proctectomy methods, Rectal Neoplasms surgery, Reoperation methods, Transanal Endoscopic Microsurgery
- Abstract
Background: Unfavorable adenocarcinoma after transanal endoscopic microsurgery requires "completion surgery" with total mesorectal excision. The literature on this procedure is very limited., Objective: This study aims to assess the percentage of transanal endoscopic microsurgery that will require completion surgery., Design: This is an observational study with prospective data collection and retrospective analysis from patients who were operated on consecutively., Settings: The study was conducted at a single academic institution., Patients: Patients undergoing transanal endoscopic microsurgery from June 2004 to December 2018 who later required total mesorectal excision were included., Main Outcome Measures: All the patients followed the same protocol: preoperative study, indication of transanal endoscopic microsurgery with curative intent, performance of transanal endoscopic microsurgery, and completion surgery indication 3 to 4 weeks after transanal endoscopic microsurgery., Results: Seven hundred seventy-four patients underwent transanal endoscopic microsurgery, 622 with curative intent (group I: adenoma, 517; group II: adenocarcinoma, 105). Completion surgery was indicated in 64 of 622 (10.3%) patients: group I, 40 of 517 (7.7%) and group II, 24 of 105 (22.9%). After applying exclusion criteria, completion surgery was performed in 55 patients (8.8%). Abdominoperineal resection was performed in 23 (45.1%); the initial lesion was within 6 cm of the anal verge in 19 of these 23 (82.6%). The clinical morbidity rate (Clavien Dindo> II) was 3 of 51 (5.9%). Total mesorectal excision was graded as complete in 42 of 49 (85.7%). The circumferential resection margin was tumor-free in 47 of 50 (94%). Median follow-up was 58 months. Local recurrence was recorded in 2 of 51 (3.9%) and systemic recurrence was recorded in 7 of 51 (13.7%); 5-year disease-free survival was 86%., Limitations: The limitations are defined by the study's observational design and the retrospective analysis., Conclusion: The indication of completion surgery after transanal endoscopic microsurgery is low, but is higher in the indication of adenocarcinoma. Compared with initial total mesorectal excision, completion surgery requires a higher rate of abdominoperineal resection, but has similar postoperative morbidity, total mesorectal excision quality, and oncological results. See Video Abstract at http://links.lww.com/DCR/B423., Ciruga Complementaria En Cncer De Recto Desfavorable Despus De Una Tem Se Obtiene Satisfactoriamente Preservacin Del Esfnter, Calidad De Muestra De Etm Y Resultados Oncolgicos a Largo Plazo: ANTECEDENTES:El adenocarcinoma con evolución desfavorable luego de una de microcirugía endoscópica transanal (TEM) requiere "cirugía de finalización" con la excisión total del mesorecto. La literatura sobre este procedimiento es muy limitada.OBJETIVO:Evaluar el porcentaje de microcirugía endoscópica transanal que requerió cirugía completa.DISEÑO:Estudio observacional con recolección prospectiva de datos y análisis retrospectivo de pacientes operados consecutivamente.AJUSTES:El estudio se realizó en una sola institución académica.PACIENTES:Aquellos pacientes sometidos a microcirugía endoscópica transanal desde junio de 2004 hasta diciembre de 2018 que luego requirieron excisón toztal del mesorecto.PRINCIPALES MEDIDAS DE RESULTADO:Todos los pacientes siguieron el mismo protocolo: estudio preoperatorio, indicación de microcirugía endoscópica transanal con intención curativa, realización de microcirugía endoscópica transanal e indicación de cirugía complementaria 3-4 semanas después de la microcirugía endoscópica transanal.RESULTADOS:Setecientos setenta y cuatro pacientes fueron sometidos a microcirugía endoscópica transanal, 622 con intención curativa (grupo I, adenoma: 517, grupo II, adenocarcinoma: 105). la cirugía complementaria fué indicada en 64/622 (10.3%), grupo I: 40/517 (7.7%) y grupo II 24/105 (22.9%). Después de aplicar los criterios de exclusión, la cirugía complementaria se realizó en 55 pacientes (8,8%). La resección abdominoperineal fué realizada en 23 (45,1%); en 19 de estos casos 23 (82,6%) la lesión inicial se encontraba dentro los 6 cm del margen anal. La tasa de morbilidad clínica (Clavien-Dindo > II) fue de 3/51 (5,9%). La excisión total del mesorecto se calificó como completa en 42/49 (85,7%). El margen de resección circunferencial se encontraba libre de tumor en 47/50 (94%). La mediana de seguimiento fue de 58 meses. La recurrencia local se registró en 2/51 (3.9%) y la recurrencia sistémica en 7/51 (13.7%); La supervivencia libre de enfermedad a 5 años fue del 86%.LIMITACIONES:Todas definidas por el diseño observacional y el análisis retrospectivo del mismo.CONCLUSIÓN:La indicación de completar la cirugía después de una TEM es baja, pero es más alta cuando la indicación es por adenocarcinoma. En comparación con la excisión total del mesorecto inicial, la cirugía complementaria requiere una tasa más alta de resección abdominoperineal, pero tiene una morbilidad postoperatoria, una calidad de excisión total del mesorecto y resultados oncológicos similares. ConsulteVideo Resumen en http://links.lww.com/DCR/B423. (Traducción-Dr. Xavier Delgadillo)., (Copyright © The ASCRS 2020.)
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- 2021
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64. Reaccreditation or recertification of general surgeons in Spain: That's the question. Results of a national survey.
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Ma Miguelena Bobadilla J, Serra Aracil X, Ma Targarona Soler E, Luis Ramos Rodríguez J, Ma Jover Navalón J, Millán Scheiding M, and Morales-García D
- Abstract
Introduction: The Law for the Regulation of Health Professions (LOPS) indicates that health professionals will carry out continuous training throughout their professional life, and will regularly prove their professional competence. The objective of the study was to carry out a national survey to find out the opinion of Spanish surgeons and thus be able to prepare a recertification project by the Spanish Association of Surgeons (AEC)., Methods: Cross-sectional observational study carried out in June-July 2020, through a survey sent to the members of the AEC., Results: The survey had a total of 1230 visits and an overall completion rate of 784 responses (67.3%). 69.6% were unaware of the LOPS forecasts and 83.4% were unaware of similar initiatives in other specialties and 95.5% agreed to demand adequate information. 71.4% believed it necessary but only 57% believed that it should be mandatory. 82.9% would agree that it should be regulated through an objective and predictable official procedure., Conclusions: The concept of re-accreditation is not well known in our specialty and in view of the results obtained, adequate and reliable information seems necessary. Therefore, it would be pertinent to propose by the AEC a specific project to assess activities and skills., (Copyright © 2020 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2021
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65. Combined endoscopic and laparoscopic surgery for the treatment of complex benign colonic polyps (CELS): observational study.
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Serra-Aracil X, Gil-Barrionuevo E, Martinez E, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, Puig-Divi V, and Navarro-Soto S
- Abstract
Purpose: Combined endoscopic and laparoscopic surgery (CELS) has emerged as a promising method for managing complex benign lesions that would otherwise require major colonic resection. The aim of this study was to describe the different techniques and to evaluate the safety of CELS, assess its outcomes in a technique that is scarcely widespread in our environment., Method: Observational retrospective study, short-term outcomes of patients undergoing CELS for benign colon polyps from October 2018 to June 2020 were evaluated. Postoperative outcomes, length of hospital stay and pathological findings were evaluated., Results: Seventeen consecutive patients underwent CELS during the study period. The median size of the lesion was 3.5 cm (range 2.5 - 6.5 cm), the most frequent location was the cecum (10 from 17). Most patients treated with CELS underwent an endoscopic-assisted laparoscopic wedge resection (11 from 17). In four patients this resection was combined with another CELS technique, and two patients underwent an endoscopic-assisted laparoscopic segment resection. The success rate of CELS in our series was in 14 from 17 (82,4%). The median operative time was 85 min (range 50-225 min). The median hospital stay was 2 days (range 1-15 days). One patient experienced an organ/space surgical site infection which did not require further intervention. Four lesions were shown to be malignant by postoperative pathology study., Conclusion: CELS is a safe and multidisciplinar technique that requires collaboration between gastroenterologists and surgeons. It can be considered as an alternative to colonic resection for complex benign colonic polyps., (Copyright © 2020 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2021
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66. Long-term outcomes of colonic stent as a "bridge to surgery"for left-sided malignant large-bowel obstruction.
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Mora-López L, Hidalgo M, Falcó J, Serra-Pla S, Pallisera-Lloveras A, Garcia-Nalda A, Criado E, Navarro-Soto S, and Serra-Aracil X
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- Aged, Aged, 80 and over, Colonic Neoplasms pathology, Disease-Free Survival, Female, Humans, Intestinal Obstruction pathology, Male, Middle Aged, Neoplasm Staging, Spain epidemiology, Treatment Outcome, Colonic Neoplasms epidemiology, Colonic Neoplasms surgery, Intestinal Obstruction epidemiology, Intestinal Obstruction surgery, Self Expandable Metallic Stents
- Abstract
Background: The role of self-expandable metallic stents (SEMS) as a bridge to surgery in left-sided malignant colonic obstruction is still debated. Here we assess the morbidity, mortality and long-term oncological outcomes as a bridge to surgery for patients with left-sided malignant colonic obstruction., Method: Prospective observational study with retrospective analysis of patients with left-sided malignant colonic obstruction undergoing stenting. April 2006-April 2018. We assessed all patients with intent-to treat and per protocol analyses and long-term follow-up variables., Results: Colonic stent was performed in 117 patients. Technical and clinical success of SEMS placement: 94.4% (111/117), only 4.3% perforation. Elective surgery resection following the strategy of SEMS was performed in 83.8% (98/117). A laparoscopic approach was: 25.6% (30/117); 76.9% in the last two years. Primary anastomosis rate: 92.8% (91/98), without protective stoma in any patients. Anastomotic leakage rate: 8.2% (8/97). Median follow-up: 44.5 months (range 0-109). The intent-to-treat analysis showed overall and disease-free survival rates of 63.3% (74/117) and 58.1% (68/117), and local and distant recurrence rates: 9.4% (11/117) and 58.1% (68/117). In the per protocol analysis, overall and disease-free survival rates: 63.2% (62/98) and 60.2% (58/98), and local and distant recurrence rates: 10.2% (10/98) and 36.7% (36/98). Disease progression was predominantly observed during the first 5 years' follow-up as disease recurrence; after five years' follow-up, 60% of the patients were disease-free., Conclusions: According to the results of the study SEMS as a bridge to surgery achieves perioperative results comparable to non-occlusive colonic cancer surgery and does not adversely affect long-term oncological outcomes. Further investigations are needed., (Copyright © 2020 Elsevier Ltd. All rights reserved.)
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- 2020
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67. A single-center prospective observational study on the effect of trimodal prehabilitation in colorectal surgery.
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Mora López L, Pallisera Llovera A, Serra-Aracil X, Serra Pla S, Lucas Guerrero V, Rebasa P, Tremps Domínguez C, Pujol Caballé G, Martínez Castela R, Subirana Giménez L, Martínez Cabañero J, Del Pino Zurita C, Agudo Arcos C, Carol Boeris FG, and Navarro Soto S
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- Aged, Colorectal Neoplasms surgery, Colorectal Surgery methods, Cross Infection epidemiology, Female, Humans, Length of Stay statistics & numerical data, Length of Stay trends, Male, Middle Aged, Morbidity trends, Physical Functional Performance, Physical Therapy Modalities statistics & numerical data, Postoperative Complications mortality, Prospective Studies, Surgical Wound Infection epidemiology, Colorectal Neoplasms rehabilitation, Colorectal Surgery statistics & numerical data, Physical Therapy Modalities adverse effects, Postoperative Complications prevention & control, Preoperative Exercise physiology
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Introduction: A trimodal prehabilitation protocol was designed with the aim to evaluate whether it contributes to reducing postoperative morbidity, to evaluate the effect of prehabilitation on overall hospital stay, and to analyze the evolution of functional capacity before and after surgery., Methods: A single-center observational study of patients with colorectal cancer who underwent surgery with curative intent after a trimodal prehabilitation protocol. We collected data for postoperative morbidity according to the Comprehensive Complication Index and hospital stay, which were compared with a historical matrix. Functional capacity data were also collected before and after the application of the prehabilitation protocol., Results: Compared to the historical population, the overall Comprehensive Complication Index was reduced from 13.2 to 11.5, which was statistically significant. Analyzed by morbidity type, all decreased in percentage, although without achieving significance (surgical site infection from 11.7% to 8.4%, nosocomial infection 15.8 to 10% and medical morbidity 8.6% to 4.2%). The overall hospital stay went from 6 to 4 days, and the decrease in the percentage of patients who prepared at home was statistically significant in both cases., Conclusions: Trimodal prehabilitation can contribute to lowering the postoperative morbidity and overall hospital stay of patients undergoing colorectal cancer surgery., (Copyright © 2020 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2020
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68. A scoring system to predict complex transanal endoscopic surgery.
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Serra-Aracil X, Rebasa-Cladera P, Mora-Lopez L, Pallisera-Lloveras A, Serra-Pla S, and Navarro-Soto S
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- Adult, Aged, Aged, 80 and over, Female, Humans, Learning Curve, Male, Middle Aged, Operative Time, Retrospective Studies, Colorectal Neoplasms surgery, Margins of Excision, Transanal Endoscopic Surgery methods
- Abstract
Background: Since the introduction of screening for colorectal cancer, the use of transanal endoscopic surgery (TEM) has become increasingly popular. However, the technical difficulty of this surgery varies widely. The few studies of learning curve in TEM have produced very disparate results. The aim of this study is to distinguish between straightforward and complex procedures, in order to refer more difficult cases to centers with greater experience., Method: Observational study with prospective data collection and retrospective analysis was carried out between June 2004 and January 2019. All TEMs performed on rectal tumors were included. The complexity of the procedure was defined according to the weighted mean surgical time for each surgeon. A predictive model of complexity was established, with a score higher than 5 indicating a complex lesion., Results: During the study period, 773 TEMs were performed, 708 of which met the study's inclusion criteria. One hundred and three tumors were defined as complex. Predictors of complexity were as follows: male sex (OR: 1.78, 95% CI 1.1-2.9, score: 1), tumor size > 5 cm (OR: 5.1, 95% CI 3.2-8.2, score: 4), TEM for recurrence (OR: 6.3, 95% CI 2.3-16.7, score: 5), and distance from the upper margin of the tumor to the anal verge > 15 cm (OR: 1.6, 95% CI 0.96-2.7, score: 1)., Conclusions: Rather than establishing the learning curve merely in terms of the number of TEM procedures performed, it is important to consider the surgical difficulty of the interventions. To this end, it is essential to differentiate simple TEMs from the complex ones.
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- 2020
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69. Let's Take Care Of Our Future.
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Serra-Aracil X, Jover Navalón JMA, Targarona EMA, and Garcia-Granero E
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- Burnout, Professional epidemiology, Burnout, Professional prevention & control, Female, Humans, Incidence, Internship and Residency standards, Male, Physical Abuse psychology, Sexism psychology, Sexual Harassment psychology, Spain epidemiology, Suicidal Ideation, Surveys and Questionnaires statistics & numerical data, United States epidemiology, Burnout, Professional psychology, Emotional Abuse psychology, Surgeons psychology
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- 2020
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70. Burnout in General Surgery Residents. Survey From the Spanish Association of Surgeons.
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Lucas-Guerrero V, Pascua-Solé M, Ramos Rodríguez JL, Trinidad Borrás A, González de Pedro C, Jover Navalón JM, Rebasa P, Targarona Soler EM, and Serra-Aracil X
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- Burnout, Professional epidemiology, Cross-Sectional Studies, Emotional Abuse psychology, Emotional Abuse statistics & numerical data, Female, Humans, Incidence, Internship and Residency statistics & numerical data, Male, Physical Abuse psychology, Physical Abuse statistics & numerical data, Racism psychology, Racism statistics & numerical data, Sexism psychology, Sexism statistics & numerical data, Sexual Harassment psychology, Sexual Harassment statistics & numerical data, Spain epidemiology, Suicidal Ideation, Surgeons organization & administration, United States epidemiology, Workplace psychology, Burnout, Professional diagnosis, Surgeons psychology, Surveys and Questionnaires statistics & numerical data
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Introduction: Physicians, especially surgeons, are significatively affected by burnout. Duty-hour violation, as well as discrimination, abuse and sexual harassment may contribute to burnout. A study about this topic has been published in residents from United States, demonstrating a high incidence of burnout. Our objective is to know which is the situation in Spain and to compare it with United States., Methods: Cross-sectional observational study carried out in January-February 2020, based on the responses to a validated survey administered to General Surgery residents in Spain., Results: There are 931 General Surgery Residents. 739 have entered in the survey and 452 (61.2%) eventually responded to it. In any occasion during the training period, 55.1% reported discrimination based on their gender, 8.8% reported racial discrimination, 73.9% reported verbal/psychological abuse, 7.1% reported physical abuse and 16.4% reported sexual harassment. Attending surgeons are the most frequent source of sexual harassment and physical and verbal abuse, whereas patients are the most frequent cause of gender discrimination. Burnout symptoms were reported by 47.6% of residents and 4.6% reported suicidal thoughts. 98% of residents reported duty-hour violations and 47% of them do not have the day off after to be on call. Both of these issues are burnout predictive factors., Conclusions: Mistreatment (discrimination, abuse and harassment) occurs among General Surgery residents during their training period in our country. Every kind of mistreatment is more frequent in Spain than in the United States, with the exception of racial discrimination. It is associated with exceeding weekly duty-hour. It is necessary to know these problems and to avoid them in order to improve work environment of General Surgery training period., (Copyright © 2020 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2020
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71. Is obesity a factor of surgical difficulty in transanal endoscopic surgery?
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Serra-Aracil X, Gil-Barrionuevo E, Lobato-Gil R, Gonzalez-Costa A, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, and Navarro-Soto S
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- Adult, Aged, Feasibility Studies, Female, Humans, Male, Middle Aged, Retrospective Studies, Risk Factors, Obesity complications, Rectal Neoplasms complications, Rectal Neoplasms surgery, Transanal Endoscopic Surgery
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Background: The aim of this study is to assess the feasibility of transanal endoscopic surgery (TES) in obese patients., Methods: Observational descriptive study evaluating the feasibility of TES in obese rectal tumors between June 2004 and January 2019. Patients were assigned to two groups: body mass index (BMI) < 30 kg/m
2 and BMI ≥30 kg/m2 , the latter defined as obese., Results: From 775 patients, 681 were enrolled in the study, 145 (21.3%) of them obese. No statistically significant differences between groups were found with respect to overall morbidity (27, 18.6%).The obese patients presented trends towards shorter mean surgical time (65 min, IQR 48 min), less perforation in the peritoneal cavity (eight, 5.5%), and 133 (91.7%) presented a lower rate of lesion fragmentation., Conclusion: There were no significant differences in postoperative outcomes in obese patients (BMI ≥30 kg/m2 ). TES in those obese patients does not represent a factor of surgical difficulty., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2020 Elsevier Inc. All rights reserved.)- Published
- 2020
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72. Multidisciplinary management and optimization of frail or high surgical risk patients in colorectal cancer surgery: Prospective observational analysis.
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Serra-Pla S, Pallisera-Lloveras A, Mora-López L, Granados Maturano A, Gallardo S, Del Pino Zurita C, and Serra-Aracil X
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- Adult, Aged, Aged, 80 and over, Colorectal Neoplasms epidemiology, Colorectal Neoplasms mortality, Comorbidity, Female, Follow-Up Studies, Frailty surgery, Geriatrics statistics & numerical data, Humans, Interdisciplinary Communication, Male, Middle Aged, Postoperative Complications epidemiology, Postoperative Complications mortality, Prospective Studies, Quality of Health Care standards, Risk Factors, Colorectal Neoplasms surgery, Frail Elderly statistics & numerical data, Frailty epidemiology, Palliative Care methods
- Abstract
Introduction: Frailty is associated with greater postoperative morbidity and mortality. Individualized multidisciplinary management of these patients can improve the quality of care. The objectives of this study are to determine the percentage of frail patients with colorectal cancer in our population, and to describe the morbidity and mortality associated with surgery and the evolution of palliative treatment., Methods: A prospective, observational study of patients with surgical colorectal cancer (February 1, 2018-April 30, 2019). Frail patients were screened and classified according to degrees of frailty. Therapeutic decision-making (surgery or palliative treatment) was determined by the degree of fragility and explicit will of the patient. Postoperative comorbidities were analyzed (according to Clavien-Dindo and Comprehensive Complication Index), as were mortality and oncological follow-up., Results: The study included 193 patients with surgical colorectal cancer, with a mean age of 74 years (44-92). Screening identified 46 frail patients (24%), with a mean age of 80 years (57-92). Twenty-two patients were optimized and underwent surgery (48%), with a mean age of 78 years (57-89). Relevant adverse effect rate was 27.7% (4 grade iva adverse effects, one ivb and one v, according to Clavien-Dindo). Comprehensive Complication Index was 17.5. Palliative treatment was administered in 24 patients (52%), with a mean age of 82 years (59-92). Mean follow-up was 7.8 months. There were 2 deaths due to disease progression (8.3%), 5 re-consultations due to complications of colorectal cancer (20.1%)., Conclusions: The multidisciplinary and individualized management of frail patients with colorectal cancer is key to improve the quality of care in the treatment of this patient group., (Copyright © 2020 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2020
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73. Combined endoscopic and laparoscopic surgery for the treatment of complex benign colonic polyps: a video vignette.
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Serra-Aracil X, Gil-Barrionuevo E, Martinez E, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, Garcia-Nalda A, Puig-Divi V, Campo R, and Navarro-Soto S
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- Colonoscopy, Humans, Colonic Polyps surgery, Laparoscopy
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- 2020
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74. A real world analysis of recurrence risk factors for early colorectal cancer T1 treated with standard endoscopic resection.
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Martínez Vila C, Oliveres Montero de Novoa H, Martínez-Bauer E, Serra-Aracil X, Mora L, Casalots-Casado A, Macías-Declara I, and Pericay C
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- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Humans, Lymph Nodes pathology, Lymphatic Metastasis pathology, Middle Aged, Neoplasm Staging, Risk Factors, Colorectal Neoplasms pathology, Colorectal Neoplasms surgery, Endoscopy, Neoplasm Recurrence, Local pathology
- Abstract
Background and Study Aim: Currently, endoscopic resection of early colorectal cancer defined as carcinoma with limited invasion of the mucosa (Tis) and submucosa (T1) is possible. However, lymph node spreading increases to 16.2% of cases when tumor invades the submucosa. We analyzed the previously identified factors for lymph node dissemination and recurrence, in our population., Patients and Methods: We analyzed retrospectively all patients with T1 tumors, treated at our center with endoscopic resection and some with additional surgery between January 2006 and January 2018. Statistical analysis was performed using IBM SPSS Statistics 25.0., Results: One hundred fifty-nine patients were treated with endoscopic resection, 56.6% with additional surgery. The mean age was 68.74 years and 69. 9% were male. All patients who underwent additional surgery presented negative margins and 8.8% presented positive lymph nodes. In a mean follow-up of 23.36 months, 13 patients had relapsed. The risk of relapse did not differ between patients treated with additional surgery from those who only underwent endoscopic resection (p = 0.506). On the other hand, lymph node dissemination (p = 0.007) and a positive endoscopic margin (p = 0.01) were independent risk factors for relapse. There was a positive association between lymph node dissemination and lymphatic (p = 0.07), vascular (p = 0.007), and perineural (p = 0.001) invasion and also with degree of histological differentiation (p = 0.001)., Conclusion: In our study, lymphatic, vascular, and perineural invasion and also the degree of histological differentiation were associated with lymph node dissemination. However, the only independent risk factors for long-term recurrence were a positive margin and lymph node dissemination.
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- 2020
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75. How to start and develop a multicenter, prospective, randomized, controlled trial.
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Serra-Aracil X, Pascua-Sol M, Badia-Closa J, and Navarro-Soto S
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- Biomedical Research economics, Biomedical Research organization & administration, Checklist, Humans, Multicenter Studies as Topic economics, Multicenter Studies as Topic methods, Randomized Controlled Trials as Topic economics, Randomized Controlled Trials as Topic methods
- Abstract
Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial. The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years. In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended. When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines. Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately. And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study., (Copyright © 2019 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2020
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76. Is Local Resection of Anal Canal Tumors Feasible with Transanal Endoscopic Surgery?
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Serra-Aracil X, Campos-Serra A, Mora-López L, Serra-Pla S, Pallisera-Lloveras A, Flores-Clotet R, Zárate-Pinedo A, and Navarro-Soto S
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- Adult, Aged, Aged, 80 and over, Anal Canal surgery, Anus Neoplasms pathology, Feasibility Studies, Female, Humans, Male, Margins of Excision, Middle Aged, Postoperative Complications etiology, Rectal Neoplasms pathology, Retrospective Studies, Anus Neoplasms surgery, Rectal Neoplasms surgery, Transanal Endoscopic Surgery adverse effects
- Abstract
Background: An important drawback of local surgery for lesions in the anal canal is the difficulty of achieving en bloc full-thickness resections. The aim of this study is to evaluate TEM/TEO in lesions of this type from the point of view of morbidity, mortality and the quality of the pathology specimen., Methods: This is an observational study with prospective data collection from June 2004 to July 2018. Two groups are defined: group A (rectal tumors with proximal margin between 0 and ≤4 cm from anal verge) and group B (distal margin > 4 cm from anal verge). A technical description is provided; resections and postoperative complications in both groups are compared., Results: During the study period, 757 patients underwent TEM/TEO. Finally, 692 patients were included, 192 patients in group A and 500 patients in group B. An en bloc surgical specimen was obtained in 176/192 patients (91.7%), although the defect was completely sutured in 132 (68.8%). In the comparative analysis, group A did not present significantly greater fragmentation of the resected piece [16/192 (8.3%) vs. 36/500 (7.2%), p = 0.630], although group A was associated with greater involvement of the surgical margin [28/192 (14.6%), 32/500 (6.4%), p = 0.001] and clinically relevant morbidity [16/192 (8.3%), 20/500 (4%), p = 0.034]. There was no mortality., Conclusions: The use of TEM/TEO to remove lesions originating in the anal canal is feasible. But we have to take into account that there is an increase in complications, technical difficulties and affected margins resection.
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- 2020
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77. Multicenter Controlled Study of Intracorporeal Mechanical Side-to-Side Isoperistaltic Anastomosis versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-Study.
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Serra-Aracil X, Pascua-Solé M, Mora-López L, Vallverdú H, Serracant A, Espina B, Ruiz C, Merichal M, Sánchez A, Romagnolo L, and Veo C
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- Anastomosis, Surgical adverse effects, Anastomosis, Surgical methods, Colectomy adverse effects, Colon, Ascending, Controlled Clinical Trials as Topic, Humans, Laparoscopy, Length of Stay, Prospective Studies, Reoperation, Adenocarcinoma surgery, Colectomy methods, Colon, Transverse surgery, Colonic Neoplasms surgery, Ileum surgery, Postoperative Complications etiology
- Abstract
Colorectal cancer is the second most frequent cancer in the Western world. A third of colorectal tumors are located in the right colon, and right hemicolectomy is the treatment in nondisseminated right colon cancer. The most serious complication of this procedure is anastomotic leak, which occurs in 8.4% of cases. At present, there is no standardized technique for laparoscopic ileo-colic anastomosis. In previous observational studies, intracorporeal side-to-side ileo-colic laparoscopic anastomosis has shown better results than extracorporeal anastomosis in terms of morbidity and mortality. It is known that randomized studies provide higher levels of evidence, but multicenter randomized controlled studies may imply a learning curve bias due to the differences in technical experience acquired at each hospital. As a result, we propose to carry out a prospective, controlled, nonrandomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND) in a large sample of 416 patients (208 per group) in order to assess the use of intracorporeal side-to-side ileo-colic laparoscopic anastomosis as the gold standard in right hemicolectomy., (© 2019 S. Karger AG, Basel.)
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- 2020
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78. TEO-Transanal Intersphincteric Intramesorectal and Laparoscopic Approach in Proctosigmoidectomy for Benign Disease.
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Serra-Aracil X, Pascua-Solé M, Serra-Pla S, Mora-López L, Pallisera-Lloveras A, Calvet X, and Navarro-Soto S
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- Adult, Aged, Female, Humans, Laparoscopy methods, Length of Stay statistics & numerical data, Male, Middle Aged, Operative Time, Treatment Outcome, Adenomatous Polyposis Coli surgery, Colitis, Ulcerative surgery, Colon, Sigmoid surgery, Crohn Disease surgery, Proctocolectomy, Restorative methods, Transanal Endoscopic Surgery methods
- Abstract
Purpose: Completion proctectomy is the traditional approach in the rectal stump remaining after subtotal colectomy for benign disease. It is associated with high morbidity and urinary and sexual dysfunction. To reduce this risk, a minimally invasive approach is presented, intersphincteric intramesorectal proctosigmoidectomy by transanal endoscopic operation and laparoscopy., Patients and Methods: Patients who had undergone total or subtotal colectomy for benign disease, those with a rectosigmoid stump who had rejected intestinal reconstruction and with refractory symptoms or risk of degeneration were selected. The technique proposed and the morbidity outcomes are described., Results: Three patients underwent this minimally invasive approach, operative time was 130 to 150 minutes. The median postoperative hospital stay was 6.6 days. Genitourinary and sexual tests performed in the male patient showed no dysfunction., Conclusions: This minimally invasive technique, with intersphincteric resection and dissection close to the rectal wall, theoretically reduces morbidity and the damage to the autonomic pelvic nerves.
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- 2019
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79. Importance of Resection Margins in the Treatment of Rectal Adenomas by Transanal Endoscopic Surgery.
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Serra-Aracil X, Ruiz-Edo N, Casalots-Casado A, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, Puig-Diví V, and Navarro-Soto S
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- Adenoma diagnosis, Adult, Aged, Biopsy, Female, Humans, Male, Middle Aged, Prospective Studies, Rectal Neoplasms diagnosis, Risk Factors, Adenoma surgery, Margins of Excision, Microsurgery methods, Proctectomy methods, Rectal Neoplasms surgery, Transanal Endoscopic Surgery methods
- Abstract
Background: Polypectomy is the gold standard for treating colorectal adenomas up to 2 cm in size. For larger lesions, various procedures ranging from endoscopy to transanal surgery can be performed and achieve varying results for en bloc resection and recurrence. There are no clear guidelines for dealing with involved resection margins. We assess the recurrence of rectal adenomas operated using TEM with full-thickness wall excision with or without free resection margins and define optimal endoscopic follow-up., Method: Observational study with prospective data collection, including patients undergoing TEM between 6/2004 and 11/2017, with definitive diagnosis of rectal adenoma. Data on epidemiological, preoperative, surgical, postoperative, pathological, and follow-up variables were recorded. Univariate analysis, follow-up risk function, and multivariate logistic regression analysis were performed to detect risk factors for recurrence., Results: TEM was indicated in 736 patients; 481 adenomas were identified in the preoperative biopsy, of which 95 were infiltrating adenocarcinomas (19.8%) in the definitive pathology study. With a minimum follow-up of 1 year, 372 patients were included. Pathology study showed free margins in 324 (87%). Recurrences were recorded in 15 patients (4%), up to 18 months in the free margins group and up to 24 months in the involved margins group. Thirteen patients with recurrence (86.6%) were treated with TEM. No predictors of recurrence were found in the multivariate analysis., Conclusion: TEM is the technique of choice for treating rectal adenomas and recurrences, achieving a low relapse rate. Follow-up must be adapted to resection margins and should be extended to 24 months.
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- 2019
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80. Transanal endoscopic microsurgery in very large and ultra large rectal neoplasia.
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Serra-Aracil X, Flores-Clotet R, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, and Navarro-Soto S
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- Aged, Feasibility Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Rectum pathology, Rectum surgery, Treatment Outcome, Tumor Burden, Intestinal Polyps pathology, Intestinal Polyps surgery, Rectal Neoplasms pathology, Rectal Neoplasms surgery, Transanal Endoscopic Microsurgery statistics & numerical data
- Abstract
Background: Transanal endoscopic microsurgery (TEM) has become the treatment of choice for benign rectal lesions and early rectal cancer (T1). The size classification of rectal polyps is controversial. Some articles define giant rectal lesions as those larger than 5 cm, which present a significantly increased risk of complications. The aim of this study was to evaluate the feasibility of TEM in these lesions., Methods: An observational descriptive study with prospective data collection evaluating the feasibility of TEM in large rectal adenomas was performed between June 2004 and September 2018. Patients were assigned to one of the three groups according to size: < 5 cm, very large (5-7.9 cm) and ultra-large (≥ 8 cm). Descriptive and comparative analyses between groups were performed., Results: TEM was indicated in 761 patients. Five hundred and seven patients (66.6%) with adenoma in the preoperative biopsy were included in the study. Three hundred and nine out of 507 (60.9%) tumors < 5 cm, 162/507 (32%) very large tumors (5-7.9 cm) and 36/507 (7.1%) ultra-large tumors (≥ 8 cm) were reviewed. Morbidity increased with tumor size: 17.5% in tumors < 5 cm, 26.5% in those 5-7.9 cm, and 36.1% in those > 8 cm. Peritoneal perforation, fragmentation, free margins and stenosis were also more common in very large and ultra-large tumors (p < 0.001). There were no statistical differences between the groups in the definitive pathology (p = 0.38)., Conclusions: TEM in these large tumors is associated with higher rates of morbidity, peritoneal perforation, free margins and stenosis. Although these tumors do not require total mesorectal excision and are eligible for TEM, the surgery must be carried out by experienced surgeons.
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- 2019
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81. Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial.
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Pallisera-Lloveras A, Planelles-Soler P, Hannaoui N, Mora-López L, Muñoz-Rodriguez J, Serra-Pla S, Dominguez-Garcia A, Prats-López J, Navarro-Soto S, and Serra-Aracil X
- Subjects
- Adult, Digestive System Surgical Procedures methods, Humans, Male, Prospective Studies, Adenocarcinoma surgery, Laparoscopy, Mesenteric Artery, Inferior, Mesenteric Veins, Postoperative Complications prevention & control, Rectal Neoplasms surgery, Sexual Dysfunction, Physiological prevention & control
- Abstract
Background: Total Mesorectal Excision (TME) is the standard surgical technique for the treatment of rectal cancer. However, rates of sexual dysfunction ofup to 50% have been described after TME, and rates of urinary dysfunction of up to 30%. Although other factors are involved, the main cause of postoperative genitourinary dysfunction is intraoperative injury to the pelvic autonomic nerves. The risk is particularly high in the inferior mesenteric artery (IMA). The aim of this study is to compare pre- and post-TME sexual dysfunction, depending on the surgical approach usedin the inferior mesenteric vessels: either directly on the IMA, or from the inferior mesenteric vein (IMV) to the IMA., Methods: Prospective, randomized,controlled study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomly assigned to one of two groups depending on the surgical approach to the inferior mesenteric vessels. The main variable is pre- and postoperative sexual dysfunction; secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, and pre- and postoperative quality of life. The sample will comprise 90 patients, 45 per group., Discussion: The aim is to demonstrate that the dissection route from the IMV towards the IMA favors the preservation of the pelvic autonomic nerves and thus reducesrates of sexual dysfunction post-surgery., Trial Registration: Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 017/315. ClinicalTrials.gov TAU-RECTALNERV-PRESERV-2018 (TRN: NCT03520088 ) (Date of registration 04/03/2018).
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- 2019
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82. The Effectiveness of Contralateral Drainage in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial.
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Serracant A, Serra-Aracil X, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, Zárate-Pinedo A, and Navarro-Soto S
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- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Prospective Studies, Risk Factors, Drainage, Ileostomy adverse effects, Plastic Surgery Procedures adverse effects, Surgical Wound Infection etiology, Surgical Wound Infection prevention & control
- Abstract
Background: Loop ileostomy reduces the rates of morbidity due to colorectal anastomotic dehiscence. For its part, ileostomy closure is associated with low mortality (0-4%) but substantial morbidity (11-37%). Incisional surgical site infection (SSI) is one of the most frequent complications (2-40%)., Methods: A single-center, prospective, randomized controlled clinical trial of two study groups: control (conventional primary skin closure) and experimental (primary skin closure with a contralateral Penrose
® drain)., Results: Seventy patients undergoing loop ileostomy closure between April 2013 and June 2017 were included (35 per branch). Four were later removed from the study. Six of the remaining 66 patients (per protocol analysis) were diagnosed with incisional SSI (9.1%); there were no statistically significant differences between the two groups (control group: 9.7%; experimental group: 8.6%) or between the risk factors associated with incisional SSI. Rates of overall and relevant morbidity (Clavien ≥ III) were considerable (28.1% and 9.1%, respectively), and there were no statistically significant differences between the two groups. No patients died., Conclusion: Contralateral drainage does not significantly affect the results of primary ileostomy closure. The rate of incisional SSI was similar in the drainage and non-drainage groups, and the overall rate of 9.1% was in the low range of those reported in the literature. The absence of mortality (0%) and the non-negligible rates of overall and relevant morbidity (28.1% and 9.1%, respectively) in our series suggest that loop ileostomy is a safe procedure. However, the bowel reconstruction involves risks that must be borne in mind., Clinical Trial Registration: The study was registered and approved by the clinical research ethics committee of the study center (reference number 2012076). Clinical trial was registered in ClinicalTrial.gov (identification number NCT02574702 and reference: ILEOS-ISS_2013).- Published
- 2019
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83. Perforation in the peritoneal cavity during transanal endoscopic microsurgery for rectal tumors: a real surgical complication with a challenging prognosis?
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Serra-Aracil X, Pallisera-Lloveras A, Mora-Lopez L, Rebasa P, Serra-Pla S, and Navarro S
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- Adult, Aged, Aged, 80 and over, Clinical Decision Rules, Female, Follow-Up Studies, Humans, Intraoperative Complications diagnosis, Intraoperative Complications etiology, Intraoperative Complications prevention & control, Male, Middle Aged, Peritoneum surgery, Prognosis, Retrospective Studies, Risk Factors, Adenocarcinoma surgery, Adenoma surgery, Intraoperative Complications surgery, Peritoneum injuries, Rectal Neoplasms surgery, Suture Techniques, Transanal Endoscopic Microsurgery adverse effects
- Abstract
Background: Perforation in the peritoneal cavity during transanal endoscopic microsurgery represents a major challenge. It is usually treated by primary suture, though some authors propose laparoscopic repair with or without ostomy. It is unclear whether perforation increases the risk of tumor dissemination., Aim: The purpose of the study is to assess the safety of primary suture of peritoneal perforation and the long-term risk of dissemination, also, to determine risk factors for perforation and to propose a predictive model for lesions with risk of perforation., Method: This is an observational study with prospective data collection at Parc Taulí University Hospital, Sabadell, of patients undergoing transanal surgery with perforation into the peritoneal cavity from June 2004 to September 2017. The main variable is postoperative morbidity and mortality. The long-term follow-up of local recurrence and peritoneal tumor dissemination is described, and a quantitative predictive model for peritoneal cavity perforation is proposed., Results: Forty-five patients out of 686 (6.6%) presented perforation into the peritoneal cavity. Ten patients (22.2%) in the perforation group had morbidity, a rate similar to the non-perforated group. There was no peritoneal dissemination in patients with adenoma or with carcinoma treated with curative intent. In the quantitative predictive model, risk factors for perforation were proximal edge of tumor > 14 cm from anal verge (6 points), size ≥ 6 cm (2), age ≥ 85 years (4), anterior quadrant (3) , and sex (2). Total scores of ≥ 6 points predicted perforation., Conclusions: Primary suture after peritoneal cavity perforation during transanal surgery is safe and does not increase the risk of recurrence or peritoneal dissemination. Our predictive model provides guidance regarding the risk of perforation and the need to suture the defect after transanal surgery resection.
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- 2019
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84. Morbidity after transanal endoscopic microsurgery: risk factors for postoperative complications and the design of a 1-day surgery program.
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Serra-Aracil X, Labró-Ciurans M, Rebasa P, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, Gracia-Roman R, and Navarro-Soto S
- Subjects
- Adenocarcinoma pathology, Adenocarcinoma surgery, Adult, Aged, Aged, 80 and over, Clinical Competence, Female, Humans, Male, Middle Aged, Patient Readmission statistics & numerical data, Platelet Aggregation Inhibitors adverse effects, Postoperative Complications, Prospective Studies, Rectal Neoplasms pathology, Rectal Neoplasms surgery, Risk Factors, Transanal Endoscopic Microsurgery adverse effects
- Abstract
Background: Transanal endoscopic microsurgery (TEM) is a minimally invasive procedure with low morbidity. The definition of risk factors for postoperative complications would help to identify the patients likely to require more care and surveillance in an ambulatory or 1-day surgery (A-OdS) program. The main endpoints are overall 30-day morbidity and relevant morbidity. The secondary objectives are to detect risk factors for complications, rehospitalization, and the time of occurrence of the postoperative complications, and to describe the adverse effects following hospitalization that the A-OdS program would avoid., Methods: This is an observational study of consecutive patients undergoing TEM between June 2004 and December 2016. Overall and relevant morbidity based on the Clavien-Dindo (Cl-D) classification were recorded, as were demographic, preoperative, surgical, and pathology variables. Univariate and multivariate analyses of the risk factors were carried out., Results: Six hundred and ninety patients underwent surgery, of whom 639 were included in the study. Overall morbidity rate was 151/639 patients (23.6%); the clinically relevant morbidity rate was 36/639 (Cl-D > II) (5.6%) and mortality 2/639 (0.3%). The most frequent complication was rectal bleeding, recorded in 16.9% (108/639 patients) and grade I in 86/108 patients (78. 9%). The period with the greatest risk of complications was the first 2 days. The rehospitalization rate after 48 h was 7%. The risk factors for complications were as follows: tumor size > 6 cm (OR 3.2, 95% CI 1.3-7.8), anti-platelet medication (OR 2.3, 95% CI 1.1-5.1), and surgeon's experience < 150 procedures (OR 2.0, 95% CI 1-4.1)., Conclusions: TEM is a safe procedure. The low rates of morbidity, re-hospitalization, and postoperative complications in the first 2 days after surgery make the procedure suitable for A-OdS.
- Published
- 2019
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85. Response to the article: Concentration of treatments can improve clinical results in complex cancer surgery.
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Morales-García D, Alcazar-Montero JA, Miguelena-Bobadilla JM, and Serra Aracil X
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- Humans, Neoplasms
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- 2019
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86. How to deal with rectal lesions more than 15 cm from the anal verge through transanal endoscopic microsurgery.
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Serra-Aracil X, Gràcia R, Mora-López L, Serra-Pla S, Pallisera-Lloveras A, Labró M, and Navarro-Soto S
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- Adenocarcinoma mortality, Aged, Aged, 80 and over, Anal Canal pathology, Cohort Studies, Female, Humans, Male, Margins of Excision, Middle Aged, Operative Time, Rectal Neoplasms mortality, Survival Rate, Treatment Outcome, Adenocarcinoma pathology, Adenocarcinoma surgery, Postoperative Complications epidemiology, Rectal Neoplasms pathology, Rectal Neoplasms surgery, Transanal Endoscopic Microsurgery
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Background: The aim of this study is to assess postoperative morbidity and mortality in tumors with a proximal margin 15 cm or more from the anal verge operated with transanal endoscopic microsurgery (TEM)., Methods: This observational study of consecutive rectal tumor patients undergoing TEM was carried out from July 2004 to June 2017. We compared the results of rectal tumors at distances of ≥15 cm (group A) and <15 cm (group B) from the anal verge., Results: During the study period 667 patients were included: 118 in group A and 549 in group B. In the comparative analysis there were no significant differences in morbidity (p = 0.23), mortality (p = 0.32) or free margin involvement (p = 0.545). Differences were observed in terms of lesion size (p < 0.001), surgical time (p < 0.001) and peritoneal cavity perforation, which were all increased in group A., Conclusion: TEM for lesions in the rectosigmoid junction is feasible and is not associated with higher morbidity or mortality., (Copyright © 2018 Elsevier Inc. All rights reserved.)
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- 2019
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87. Transanal endoscopic micro-surgery in elderly and very elderly patients: a safe option? Observational study with prospective data collection.
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Serra-Aracil X, Serra-Pla S, Mora-Lopez L, Pallisera-Lloveras A, Labro-Ciurans M, and Navarro-Soto S
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- Aged, Aged, 80 and over, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Morbidity trends, Postoperative Complications epidemiology, Prospective Studies, Rectal Neoplasms epidemiology, Spain epidemiology, Survival Rate trends, Data Collection methods, Rectal Neoplasms surgery, Rectum surgery, Transanal Endoscopic Microsurgery methods
- Abstract
Background: Although the incidence of colorectal cancer increases with the patient's age, the elderly continue to be less likely to be scheduled for surgery. Transanal endoscopic micro-surgery (TEM) is a surgical alternative to total mesorectal excision (TME) in early stage rectal cancer and/or in selected patients that could decrease morbidity and mortality rates in this group of patients. Our main objective is to assess the safety and feasibility of TEM in elderly (75-84 years) and very elderly (≥ 85 years) patients., Methods: Observational study was conducted with prospective data collection of all consecutive patients who underwent TEM between April 2004 and January 2017. Patients were assigned to groups according to age. Descriptive and comparative analyses between groups were performed., Results: We analyzed 693 patients, 429 patients < 75 years (61.9%), 220 patients between the ages of 75 and 84 (31.7%), and 44 patients ≥ 85 years old (6.3%). The tendency in our series is to increase comorbidities with age. Palliative or consensus intent was more frequently performed in elderly (10.5%, 34/220), and very elderly (45.4%, 20/44), compared with the youngest (6.3%, 27/429), (p < 0.001). Global morbidity presented an increasing trend related to age from 20.3% in < 75 years, to 25.9% in elderly and 34.1% in very elderly. Surgical complications were recorded in 18.5% (128/693) of patients with no significant differences between groups. The most common one was rectal bleeding 16.1% (111/693). Significant differences were found in non-surgical complications, recorded in 7.3% (16/220) in the elderly, and 15.9% (7/44) in the group above 84 years (p = 0.013)., Conclusions: TEM presents acceptable morbidity rates mainly due to non-surgical-related adverse effects in elderly and very elderly patients and may be a feasible and safe alternative in this population in both curative and non-curative indications.
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- 2019
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88. Transanal endoscopic surgery is effective and safe after endoscopic polypectomy of potentially malignant rectal polyps with questionable margins.
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Serra-Aracil X, Pallisera-Lloveras A, Mora-Lopez L, Serra-Pla S, Puig-Diví V, Casalots À, Martínez-Bauer E, and Navarro-Soto S
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- Adenocarcinoma mortality, Adenocarcinoma pathology, Age Factors, Aged, Colonic Polyps mortality, Colonic Polyps pathology, Databases, Factual, Disease-Free Survival, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Invasiveness pathology, Neoplasm Recurrence, Local pathology, Neoplasm Recurrence, Local surgery, Neoplasm Staging, Patient Safety, Rectal Neoplasms mortality, Rectal Neoplasms pathology, Reoperation methods, Reoperation mortality, Retrospective Studies, Risk Assessment, Sex Factors, Survival Analysis, Time Factors, Treatment Outcome, Adenocarcinoma surgery, Colonic Polyps surgery, Margins of Excision, Proctoscopy methods, Rectal Neoplasms surgery, Transanal Endoscopic Surgery methods
- Abstract
Aim: To determine the percentage of residual lesion observed in the pathology study of transanal endoscopic surgery (TEM) specimens after endoscopic polypectomy of malignant rectal polyps with questionable margins, and the need for further surgery. Secondary aims: to determine the morbidity and mortality associated with this procedure and to identify the percentage of recurrence after excision by TEM., Methods: Observational study with prospective data collection of all patients undergoing TEM after endoscopic polypectomy for malignant rectal polyps or non-invasive high-grade neoplasia, from January 2004 to December 2016. An en bloc full-thickness wall excision of the scar was performed. Variables recorded: histology of TEM specimen, 30-day morbidity and mortality according to the Clavien-Dindo classification, need for salvage surgery and recurrence., Results: Fifty out of 690 patients undergoing TEM during the study period (36 adenocarcinomas, five non-invasive high-grade neoplasias and 9 neuroendocrine tumors) were included. Post-surgery histology showed residual lesion in 21 (42%) patients: 7 neuroendocrine tumors, 10 adenomas and 4 adenocarcinomas (two pT1, one pT2 and one pT3). The pT2 and pT3 patients (4%) underwent salvage surgery. No recurrence was observed, and mean follow-up was 29.1Â ± 21.6 months. The 30-day morbidity rate was 14%, but 4/7 with Clavien-Dindo grade I., Conclusions: After endoscopic polypectomy of malignant rectal polyps with questionable margins, the presence of residual lesion in the pathology study of transanal resection specimens is high. TEM with full-thickness resection of these lesions is an appropriate treatment, allowing disease control and achieving minimal morbidity., (Colorectal Disease © 2018 The Association of Coloproctology of Great Britain and Ireland.)
- Published
- 2018
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89. Endorectal ultrasound in the identification of rectal tumors for transanal endoscopic surgery: factors influencing its accuracy.
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Serra-Aracil X, Gálvez A, Mora-López L, Rebasa P, Serra-Pla S, Pallisera-Lloveras A, Zerpa C, Moreno O, and Navarro-Soto S
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- Adenocarcinoma surgery, Aged, Female, Humans, Male, Patient Selection, Prospective Studies, Rectal Neoplasms surgery, Rectum, Reproducibility of Results, Adenocarcinoma diagnosis, Endosonography methods, Neoplasm Staging methods, Rectal Neoplasms diagnosis, Transanal Endoscopic Surgery methods
- Abstract
Endorectal ultrasound (ERUS) is considered the technique of choice for selecting patients for transanal endoscopic surgery (TEM). The aim of this study was to evaluate the accuracy of ERUS in patients with rectal tumors who later underwent TEM, and to analyze the factors that influence this accuracy. Observational study including prospective data collection of patients with rectal tumors undergoing TEM with curative intent between June 2004 and May 2016. Preoperative staging by EUS (uT) was correlated with the pathology results after TEM (pT). The accuracy of the EUS was evaluated and a series of variables (tumor morphology, height, lesion size, quadrant, definitive pathology, the surgeon assessing the ERUS, and waiting time from the date of the ERUS until surgery) were analyzed as possible predictors of diagnostic accuracy. Six hundred and fifty-one patients underwent TEM, of whom 495 met the inclusion criteria. The overall accuracy of EUS was 78%, sensitivity 83.78%, specificity 20%, PPV 91.3%, and NPV 11%. Forty patients (8.08%) were understaged and 50 (10.9%) were overstaged. In the multivariate analysis, the surgeon's experience emerged as the most important predictor of accuracy (p < 0.001; OR 2.75, 95% CI 1.681-4.512). The EUS was less accurate with larger lesions (p = 0.004; OR 0.219, 95% CI 0.137-0.349) and when the definitive diagnosis was adenocarcinoma (p < 0.001; OR 0.84, 95% CI 0.746-0.946). ERUS accuracy rates are variable and there is a possibility of understaging and overstaging that must be taken into consideration. This accuracy is dependent on the operator's experience as well on lesion size; in addition, it is lower for lesions shown to be cancers in the final pathology report.
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- 2018
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90. Reply by the Authors.
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Serra-Aracil X, Labró-Ciurans M, Mora-López L, Muñoz-Rodríguez J, Martos-Calvo R, Prats-López J, and Navarro-Soto S
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- Humans, Transanal Endoscopic Surgery, Urethral Diseases, Rectal Fistula, Urinary Fistula
- Published
- 2018
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91. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer.
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Serra-Aracil X, Zárate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargalló J, Pando A, Delgado S, Balleteros E, and Pericay C
- Subjects
- Endpoint Determination, Follow-Up Studies, Humans, Informed Consent, Prospective Studies, Sample Size, Anal Canal surgery, Digestive System Surgical Procedures methods, Laparoscopy, Rectal Neoplasms surgery
- Abstract
Purpose: Compared with the open approach, laparoscopic total mesorectal excision (TME) achieves faster patient recovery, reduces morbidity rates, and shortens hospital stay. However, in laparoscopic low anterior resection (L-LAR), conversion to open surgery is required in almost 20% of cases. Transanal TME (Ta-TME) combined with laparoscopy, also called hybrid natural orifice transluminal endoscopic surgery (NOTES), is a less invasive procedure that can overcome some of the limitations of laparoscopic rectal surgery. In this study, we aim to determine whether Ta-TME has a lower rate of conversion to open surgery than L-LAR, and thus achieves faster patient recovery without altering the pathological, functional, or oncological results. The main objective is to compare the results for conversion to open surgery between Ta-TME and L-LAR., Methods: Multicenter, prospective randomized controlled study of patients diagnosed with rectal adenocarcinoma who will be randomly allocated to Ta-TME or L-LAR groups after the application of inclusion and exclusion criteria. The main endpoint is conversion to open surgery and the secondary endpoints are general morbidity and mortality and hospital stay. Demographic, surgical, and pathological variables will also be studied, along with quality of life and survival. A sample size of 53 patients per group is calculated. With an estimated loss of 10%, the final sample required will be 116 patients., Conclusions: Ta-TME achieves a lower conversion rate to open surgery than L-LAR, thus improving patient recovery and reducing overall morbidity., Trial Registration: ClinicalTrials.gov Identifier: NCT02550769. Registration no. Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 2014/064.
- Published
- 2018
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92. Non-inferiority multicenter prospective randomized controlled study of rectal cancer T 2 -T 3s (superficial) N 0 , M 0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME).
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Serra-Aracil X, Pericay C, Golda T, Mora L, Targarona E, Delgado S, Reina A, Vallribera F, Enriquez-Navascues JM, Serra-Pla S, and Garcia-Pacheco JC
- Subjects
- Follow-Up Studies, Humans, Informed Consent, Intention to Treat Analysis, Neoplasm Staging, Prospective Studies, Sample Size, Treatment Outcome, Neoadjuvant Therapy, Rectal Neoplasms pathology, Rectal Neoplasms surgery
- Abstract
Purpose: The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME), in many cases requires a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal verge, achieves minimal postoperative morbidity and mortality rates, and does not require an ostomy. The treatment of T2, N0, and M0 cancers remains controversial. Preoperative chemoradiotherapy (CRT) in association with TEM reduces local recurrence and increases survival. The TAU-TEM study aims to demonstrate the non-inferiority of the oncological outcomes and the improvement in morbidity and quality of life achieved with TEM compared with TME., Methods: Prospective, multicenter, randomized controlled non-inferiority trial includes patients with rectal adenocarcinoma less than 10 cm from the anal verge and up to 4 cm in size, staged as T2 or T3-superficial N0-M0. Patients will be randomized to two areas: CRT plus TEM or radical surgery (TME). Postoperative morbidity and mortality will be recorded and patients will complete the quality of life questionnaires before the start of treatment, after CRT in the CRT/TEM arm, and 6 months after surgery in both arms. The estimated sample size for the study is 173 patients. Patients will attend follow-up controls for local and systemic relapse., Conclusions: This study aims to demonstrate the preservation of the rectum after preoperative CRT and TEM in rectal cancer stages T2-3s, N0, M0 and to determine the ability of this strategy to avoid the need for radical surgery (TME)., Trial Registration: ClinicalTrials.gov identifier: NCT01308190. Número de registro del Comité de Etica e Investigación Clínica (CEIC) del Hospital universitario Parc Taulí: TAU-TEM-2009-01.
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- 2018
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93. The Place of Transanal Endoscopic Surgery in the Treatment of Rectourethral Fistula.
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Serra-Aracil X, Labró-Ciurans M, Mora-López L, Muñoz-Rodríguez J, Martos-Calvo R, Prats-López J, and Navarro-Soto S
- Subjects
- Aged, Humans, Male, Middle Aged, Urologic Surgical Procedures methods, Rectal Fistula surgery, Transanal Endoscopic Surgery, Urethral Diseases surgery, Urinary Fistula surgery
- Abstract
Objective: To assess the role of transanal endoscopic operation (TEO) or transanal endoscopic microsurgery (TEM) in rectourethral fistulas (RUF). RUF may appear after radical prostatectomy. Their treatment represents a challenge; many therapies have been proposed, from conservative to aggressive surgical approaches. Transanal endoscopic surgery (TEO or TEM) is a minimally invasive technique to access the site of the RUF to perform repair., Materials and Methods: This is an observational study with prospective data collection, conducted between September 2006 and December 2015. All patients were diagnosed with RUF following management of prostate cancer. Conservative treatment was administered in the form of urinary and fecal diversion with cystotomy and terminal colostomy, to achieve total urinary and fecal exclusion. If the fistula persisted, it was treated by TEO or TEM, with or without biological mesh interposition. If this failed, gracilis muscle was applied as salvage therapy., Results: Ten patients were diagnosed with RUF. In 1 patient (1 of 10), the fistula healed with bladder catheterization alone. In another patient (1 of 9), it resolved after total urinary and fecal exclusion. Eight patients underwent repair by TEO or TEM, 4 with biological mesh interposition; all 4 presented recurrence. In the other 4 patients treated via TEO or TEM, 2 had early recurrence, whereas the others had healed at follow-up visits after 4-6 months (2 of 8)-a success rate of 25%. The 6 patients who recurred were treated with gracilis muscle interposition via a transperineal approach., Conclusion: The low rate of positive results obtained by TEO or TEM argues against its use as technique of choice in RUF, and against the use of biological meshes., (Copyright © 2017 Elsevier Inc. All rights reserved.)
- Published
- 2018
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94. [Functional impairment and quality of life after rectal cancer surgery].
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Mora L, Zarate A, Serra-Aracil X, Pallisera A, Serra S, and Navarro-Soto S
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- Cohort Studies, Digestive System Surgical Procedures, Female, Humans, Laparoscopy, Male, Middle Aged, Retrospective Studies, Anal Canal physiopathology, Quality of Life, Rectal Neoplasms physiopathology, Rectal Neoplasms surgery, Rectum physiopathology
- Abstract
Objective: This study determines the quality of life and the anorectal function of these patients., Method: Observational study of two cohorts comparing patients undergoing rectal tumor surgery using TaETM or conventional ETM after a minimum of six months of intestinal transit reconstruction. EORTC-30, EORTC-29 quality of life questionnaires and the anorectal function assessment questionnaire (LARS score) are applied. General variables are also collected., Results: 31 patients between 2011 and 2014: 15 ETM group and 16 TaETM. We do not find statistically significant differences in quality of life questionnaires or in anorectal function. Statistically significant general variables: longer surgical time in the TaETM group. Nosocomial infection and minor suture failure in the TaETM group., Conclusion: The performance of TaETM achieves the same results in terms of quality of life and anorectal function as conventional ETM., (Copyright: © 2018 Permanyer.)
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- 2018
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95. Multicentre, controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics.
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Mora Lopez L, Ruiz-Edo N, Serra Pla S, Pallisera Llovera A, Navarro Soto S, and Serra-Aracil X
- Subjects
- Acute Disease, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Dietary Fiber administration & dosage, Humans, Prospective Studies, Severity of Illness Index, Ambulatory Care methods, Anti-Bacterial Agents therapeutic use, Diverticulitis therapy, Research Design
- Abstract
Purpose: Acute diverticulitis (AD) is a highly prevalent disease in Spain. Its chronic-recurrent appearance and high rate of relapse mean that it has a major epidemiological and economic impact on our health system. In spite of this, it has not been studied in any great depth. Reassessing its etiopathology, recent studies have observed that it is an inflammatory disease-not, as classic theories had postulated, an infectious one. In the light of these findings, the suitability of antibiotics for its treatment has been reconsidered. At present, however, the evidence for incorporating these findings into clinical practice guidelines remains insufficient., Methods: This study was designed to analyse the safety and efficacy of a non-antibiotic treatment for mild AD. Patients with mild AD (grade 0 in the modified Neff classification) who meet the inclusion criteria will be randomly assigned to one of two outpatient treatment strategies: (a) classical treatment (antibiotics, anti-inflammatories and low-fibre diet) or (b) experimental treatment (anti-inflammatories and low-fibre diet). Clinical controls will be performed at 2, 7, 30, and 90 days. We will determine whether there are any differences in the clinical outcome between groups. The main objective is to demonstrate that antibiotics neither accelerate the resolution of the disease nor decrease the number of complications and/or recurrences in these patients, suggesting that their use may be unnecessary., Conclusions: The results of this trial will help to optimize and homogenize the treatment of this highly prevalent disease. However, more studies are required before firm changes can be introduced in international clinical practice guidelines., Trial Registration: The trial has been registered at the ClinicalTrials.gov database (ID: NCT02785549) and the EU Clinical Trials Register database (EudraCT number: 2016-001596-75).
- Published
- 2017
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96. Current outcomes and predictors of treatment failure in patients with surgical site infection after elective colorectal surgery. A multicentre prospective cohort study.
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Gomila A, Badia JM, Carratalà J, Serra-Aracil X, Shaw E, Diaz-Brito V, Castro A, Espejo E, Nicolás C, Piriz M, Brugués M, Obradors J, Lérida A, Cuquet J, Limón E, Gudiol F, and Pujol M
- Subjects
- Age Factors, Aged, Anti-Bacterial Agents therapeutic use, Cohort Studies, Coinfection drug therapy, Colorectal Surgery mortality, Drug Resistance, Multiple, Bacterial, Female, Gram-Negative Bacterial Infections complications, Gram-Negative Bacterial Infections drug therapy, Humans, Laparoscopy, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Risk Factors, Treatment Outcome, Colorectal Surgery adverse effects, Surgical Wound Infection drug therapy, Treatment Failure
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Objective: To determine current outcomes and predictors of treatment failure among patients with surgical site infection (SSI) after colorectal surgery., Methods: A multicentre observational prospective cohort study of adults undergoing elective colorectal surgery in 10 Spanish hospitals (2011-2014). Treatment failure was defined as persistence of signs/symptoms of SSI or death at 30 days post-surgery., Results: Of 3701 patients, 669 (18.1%) developed SSI; 336 (9.1%) were organ-space infections. Among patients with organ-space SSI, 81.2% required source control: 60.4% reoperation and 20.8% percutaneous/transrectal drainage. Overall treatment failure rate was 21.7%: 9% in incisional SSIs and 34.2% in organ-space SSIs (p < 0.001). Median length of stay was 15 days (IQR 9-22) for incisional SSIs and 24 days (IQR 17-35) for organ-space SSIs (p < 0.001). One hundred and twenty-seven patients (19%) required readmission and 35 patients died (5.2%). Risk factors for treatment failure among patients with organ-space SSI were age ≥65 years (OR 1.83, 95% CI: 1.07-1.83), laparoscopy (OR 1.7, 95% CI: 1.06-2.77), and reoperation (OR 2.8, 95% CI: 1.7-4.6)., Conclusions: Rates of SSI and treatment failure in organ-space SSI after elective colorectal surgery are notably high. Careful attention should be paid to older patients with previous laparoscopy requiring reoperation for organ-space SSI, so that treatment failure can be identified early., (Copyright © 2017 The British Infection Association. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2017
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97. The use of the modified Neff classification in the management of acute diverticulitis.
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Mora López L, Flores Clotet R, Serra Aracil X, Montes Ortega N, and Navarro Soto S
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- Acute Disease, Adult, Aged, Aged, 80 and over, Clinical Protocols, Combined Modality Therapy, Diverticulitis, Colonic complications, Diverticulitis, Colonic therapy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Systemic Inflammatory Response Syndrome diagnosis, Systemic Inflammatory Response Syndrome etiology, Treatment Outcome, Diverticulitis, Colonic classification, Diverticulitis, Colonic diagnostic imaging, Severity of Illness Index, Tomography, X-Ray Computed
- Abstract
Introduction: Acute diverticulitis (AD) is increasingly seen in Emergency services. The application of a reliable classification is vital for its safe and effective management., Objective: To determine whether the combined use of the modified Neff radiological classification (mNeff) and clinical criteria (systemic inflammatory response syndrome [SIRS] and comorbidity) can ensure safe management of AD., Material and Methods: Prospective descriptive study in a population of patients diagnosed with AD by computerized tomography (CT). The protocol applied consisted in the application of the mNeff classification and clinical criteria of SIRS and comorbidity to guide the choice of outpatient treatment, admission, drainage or surgery., Results: The study was carried out from February 2010 to February 2016. A total of 590 episodes of AD were considered: 271 women and 319 men, with a median age of 60 years (range: 25-92 years). mNeff grades were as follows: grade 0 (408 patients 70.6%); 376/408 (92%) were considered for home treatment; of these 376 patients, 254 (67.5%) were discharged and controlled by the Home Hospitalization Unit; 33 returned to the Emergency Room for consultation and 22 were re-admitted; the success rate was 91%. Grade Ia (52, 8.9%): 31/52 (59.6%) were considered for outpatient treatment; of these 31 patients, 11 (35.5%) were discharged; eight patients returned to the Emergency Room for consultation and five were re-admitted. Grade Ib (49, 8.5%): five surgery and two drainage. Grade II (30, 5.2%): ten surgery and four drainage. Grade III (5, 0.9%): one surgery and one drainage. Grade IV (34, 5.9%): ten patients showed good evolution with conservative treatment. Of the 34 grade IV patients, 24 (70.6%) underwent surgery, and three (8.8%) received percutaneous drainage., Conclusions: The mNeff classification is a safe, easy-to-apply classification based on CT findings. Together with clinical data and comorbidity data, it allows better management of AD.
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- 2017
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98. Neoadjuvant therapy and transanal endoscopic surgery in T2-T3 superficial, N0, M0 rectal tumors. Local recurrence, complete clinical and pathological response.
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Serra-Aracil X, Pericay C, Mora-Lopez L, Garcia Pacheco JC, Latorraca JI, Ocaña-Rojas J, Casalots A, Ballesteros E, and Navarro-Soto S
- Subjects
- Aged, Aged, 80 and over, Chemoradiotherapy, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local epidemiology, Neoplasm Staging, Neoplasms, Second Primary epidemiology, Rectal Neoplasms pathology, Rectal Neoplasms therapy, Retrospective Studies, Treatment Outcome, Rectal Neoplasms surgery, Transanal Endoscopic Surgery
- Abstract
Introduction: The association of preoperative chemoradiotherapy and transanal endoscopic surgery in T2 and superficial T3 rectal cancers presents promising results in selected patients. The main objective is to evaluate the long-term loco-regional and systemic recurrence and, as secondary objectives, to provide results of postoperative morbidity and the correlation between complete clinical and pathological response., Methods: This is a retrospective observational study including a consecutive series of patients with T2-T3 superficial rectal cancer, N0, M0 who refused radical surgery (2008-2016). The treatment consisted of preoperative chemotherapy (5-fluorouracil or capecitabine) combined with radiotherapy (50, 4Gy) and transanal endoscopic surgery after 8weeks. Preoperative, surgical, pathological and long-term oncologic results were analyzed., Results: Twenty-four patients were included in the study. Two of them required rescue radical surgery for unfavorable pathological results. A local recurrence (4.5%) was observed and 2patients presented systemic recurrence (9%), with a median follow-up of 45 months. A complete clinical tumor response was achieved in 12 patients (50%), and complete pathological tumor response in 9 patients (37.5%). Postoperative complications were observed in 5 patients (20.8%), and they were mild except one. There was no postoperative mortality., Conclusions: In this stage of rectal cancer, our results seem to support this strategy, mainly when a complete pathological response is achieved. The complete clinical tumor response does not coincide with the pathological tumor response. Randomized prospective studies should be performed to standardize this treatment., (Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.)
- Published
- 2017
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99. Preventing Parastomal Hernia Using a Modified Sugarbaker Technique With Composite Mesh During Laparoscopic Abdominoperineal Resection: A Randomized Controlled Trial.
- Author
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López-Cano M, Serra-Aracil X, Mora L, Sánchez-García JL, Jiménez-Gómez LM, Martí M, Vallribera F, Fraccalvieri D, Serracant A, Kreisler E, Biondo S, Espín E, Navarro-Soto S, and Armengol-Carrasco M
- Subjects
- Aged, Double-Blind Method, Female, Humans, Laparoscopy methods, Male, Postoperative Complications mortality, Prospective Studies, Rectal Neoplasms mortality, Spain, Treatment Outcome, Abdominal Wall surgery, Colostomy, Hernia, Ventral prevention & control, Postoperative Complications prevention & control, Rectal Neoplasms surgery, Surgical Mesh
- Abstract
Objective: The aim of this study was to assess the reduction in the incidence of parastomal hernia (PH) after placement of prophylactic synthetic mesh using a modified Sugarbaker technique when a permanent end-colostomy is needed., Summary of Background Data: Prevention of PH formation is crucial given the high prevalence of PH and difficulties in the surgical repair of PH., Methods: A randomized, prospective, double-blind, and controlled trial. Rectal cancer patients undergoing laparoscopic abdominoperineal resection with permanent colostomy were randomized (1 : 1) to the mesh and nonmesh arms. In the mesh group, a large-pore lightweight composite mesh was placed in the intraperitoneal/onlay fashion using a modified Sugarbaker technique. PH was detected by computed tomography (CT) after a minimum follow-up of 12 months. Analysis was per-protocol., Results: The mesh group included 24 patients and the control group 28. Preoperative data, surgical time, and postoperative morbidity were similar. The median follow-up was 26 months. After CT examination, 6 of 24 PHs (25%) were observed in the mesh group compared with 18 of 28 (64.3%) in the nonmesh group (odds ratio 0.39, 95% confidence interval 0.18-0.82; P = 0.005). The Kaplan-Meier curves showed significant differences in favor of the mesh group (long-rank = 4.21, P = 0.04). The number needed to treat was 2.5, which confirmed the effectiveness of the intervention., Conclusions: Placement of a prosthetic mesh by the laparoscopic approach following the modified Sugarbaker technique is safe and effective in the prevention of PH, reducing significantly the incidence of PH.
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- 2016
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100. Further evidence for preoperative chemoradiotherapy and transanal endoscopic surgery (TEM) in T2-3s,N0,M0 rectal cancer.
- Author
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Pericay C, Serra-Aracil X, Ocaña-Rojas J, Mora-López L, Dotor E, Casalots A, Pisa A, and Saigí E
- Subjects
- Adenocarcinoma mortality, Aged, Aged, 80 and over, Antineoplastic Agents administration & dosage, Capecitabine administration & dosage, Female, Fluorouracil administration & dosage, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Prospective Studies, Rectal Neoplasms mortality, Treatment Outcome, Adenocarcinoma therapy, Chemoradiotherapy, Chemoradiotherapy, Adjuvant methods, Neoadjuvant Therapy methods, Rectal Neoplasms therapy, Transanal Endoscopic Surgery methods
- Abstract
Purpose: Preoperative chemoradiotherapy and local excision via transanal endoscopic surgery (TEM) in T2-3s,N0,M0 rectal cancer achieve promising results in selected patients. We describe our long-term follow-up experience with this combination, and evaluate complete clinical and pathological responses, local recurrence and overall survival., Methods: The prospective observational follow-up study carried out since 2007. Out of 476 consecutive patients treated with TEM, we selected those with adenocarcinoma of low or moderate grade of differentiation, clinical stages T2-superficial T3,N0,M0, who refused radical surgery. Preoperative chemoradiotherapy comprised 5-fluorouracil or capecitabine combined with radiotherapy at a dose of 50.4 Gy. TEM was performed after 8 weeks. Complications were recorded and long-term follow-up was conducted., Results: Fifteen patients undergoing preoperative chemoradiotherapy and TEM (median age 76 years, 95 % CI 70.3-80.4, and median follow-up 38 months, 95 % CI 20-44) were studied. No local recurrence was observed, and only one patient (6.7 %) presented systemic relapse. The overall survival was 76 %. Complete clinical response was achieved in seven patients (46.7 %) and complete pathological response in four (26.7 %). With regard to toxicity associated with neoadjuvant treatment, four patients (26.7 %) developed grade 3 adverse effects; no grade 4 or 5 adverse effects were observed. There was no postoperative mortality., Conclusions: The results of our study, with a response rate of 26.7 % and without local relapse, support the treatment of T2-3s,N0,M0 of rectal cancer with preoperative chemoradiotherapy and local excision (TEM).
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- 2016
- Full Text
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