Trials

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.This research program is funded by the French Ministry of Health through Programme Hospitalier de Recherche Clinique 2016

Design & implementation of a simulation-based care pathway to training in laparoscopic colorectal surgery

Rationnel: La simulation en chirurgie colorectale laparoscopique (CCL) est peu évaluée & n'a jamais été analysée en parcours de soin. Objectifs: Etudier & développer 1 formation en parcours de soin simulé (FPSS) en CCL: patients virtuels en périopératoire & programme d'entrainement virtuel (PEV) peropératoire. Déterminer si cette FPSS améliore la prise en charge des malades. Méthodes: 1) Développement d'1 FPPS pour l'appendicite. Test de sa faisabilité auprès des internes d'un service de chirurgie & évaluation de son impact sur 38 patients admis pour appendicite avant (n=21) & après (n=17) FPSS. 2) Développement d'1 FPPS en CCL respectant les objectifs de réhabilitation précoce (ORP) & validation d'un PEV en CCL. Impact de sa mise en place auprès des internes d'un service, sur 20 patients inclus prospectivement avant (n=10) & après (n=10) FPSS.Résultats: 1) Tous les internes ont suivi la FPSS. Les données pré/peropératoires étaient comparables entre les 2 groupes patients. Les délais de réalimentation liquide & solide étaient réduits après FPSS (7h (2-20) vs. 4 (4-6); P = 0.004 & 17h (4-48) vs. 6 (4-24); P = 0.005) sans modifier la morbidité ni la durée d'hospitalisation (DH). 2) La participation des internes comme opérateur a augmenté après FPSS (0% (0-100) vs. 82.5% (10-100); P = 0.006). Les données pré/peropératoires étaient comparables entre les 2 groupes patients. Le respect des objectifs de RP était meilleur à J2 après FPSS (3 (30%) vs. 8 (80%); P = 0.035). La morbidité & la DH étaient inchangées. Conclusion: Une FPSS en CCL a montré sa faisabilité. Elle a amélioré le respect des ORP & augmenté la participation des internes sans altérer les suites opératoires.Background: Few studies have assessed simulation in laparoscopic colorectal surgery (LCS) & simulation has never been designed in a care pathway approach (CPA) manner. Objectives: To design a CPA to training in LCS, involving virtual patients perioperative training & a virtual competency-based curriculum for intraoperative training. To implement such CPA & to look whether such training may improve patients' management. Methods:1) A CPA to training in appendicitis was designed and implemented. All residents of our department were trained & 38 patients undergoing appendectomy were prospectively included before (n=21) and after (n=17) CPA. 2) A CPA to training in LCS was designed in accordance with enhanced recovery (ER) recommendations, and a curriculum in LCS was validated. All residents of our department were trained & 20 patients were prospectively included before (n = 10) and after (n = 10) CPA. Results: 1) All residents were trained. Pre/intraoperative data were comparable between groups of patients. Times to liquid and solid diet were reduced after CPA (7 h (2-20) vs. 4 (4-6); P=0.004 & 17 h (4-48) vs. 6 (4-24); P=0.005) without changing postoperative morbidity & length of stay (LS). 2) Residents' participation in LCS improved afterCPA (0% (0-100) vs. 82.5% (10-100); P = 0.006). Pre/intraoperative data were comparable between groups of patients. Compliance for ER improved at day 2 in post-training patients (3 (30%) vs. 8 (80%); P = 0.035). Postoperative morbidity and LS were comparable. Conclusion: A CPA to training in LCS has been designed and implemented. It improved compliance for ER & residents participation without adversely altering patients' outcomes

Impact de la laparoscopie sur la fertilité après coloproctectomie totale et anastomose iléo-anale chez la femme (étude bi-centrique)

AIX-MARSEILLE2-BU Méd/Odontol. (130552103) / SudocSudocFranceF

A Virtual Reality Training Curriculum for Laparoscopic Colorectal Surgery

OBJECTIVE: Training within a competency-based curriculum (CBC) outside the operating room enhances performance during real basic surgical procedures. This study aimed to design and validate a virtual reality CBC for an advanced laparoscopic procedure: sigmoid colectomy. DESIGN: This was a multicenter randomized study. Novice (surgeons who had performed 50) were enrolled. Validity evidence for the metrics given by the virtual reality simulator, the LAP Mentor, was based on the second attempt of each task in between groups. The tasks assessed were 3 modules of a laparoscopic sigmoid colectomy (medial dissection [MD], lateral dissection [LD], and anastomosis) and a full procedure (FP). Novice surgeons were randomized to 1 of 2 groups to perform 8 further attempts of all 3 modules or FP, for learning curve analysis. SETTING: Two academic tertiary care centers-division of surgery of St. Mary's campus, Imperial College Healthcare NHS Trust, London and Nord Hospital, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille Université, Marseille, were involved. PARTICIPANTS: Novice surgeons were residents in digestive surgery at St. Mary's and Nord Hospitals. Intermediate and experienced surgeons were board-certified academic surgeons. RESULTS: A total of 20 novice surgeons, 7 intermediate surgeons, and 6 experienced surgeons were enrolled. Evidence for validity based on experience was identified in MD, LD, and FP for time (p = 0.005, p = 0.003, and p = 0.001, respectively), number of movements (p = 0.013, p = 0.005, and p = 0.001, respectively), and path length (p = 0.03, p = 0.017, and p = 0.001, respectively), and only for time (p = 0.03) and path length (p = 0.013) in the anastomosis module. Novice surgeons' performance significantly improved through repetition for time, movements, and path length in MD, LD, and FP. Experienced surgeons' benchmark criteria were defined for all construct metrics showing validity evidence. CONCLUSIONS: A CBC in laparoscopic colorectal surgery has been designed. Such training may reduce the learning curve during real colorectal resections in the operating room

Development of a novel educational tool to assess skills in laparoscopic liver surgery using the Delphi methodology: the laparoscopic liver skills scale (LLSS)

International audienc

A Total Laparoscopic Approach Reduces the Infertility Rate After Ileal Pouch-Anal Anastomosis: A 2-Center Study

Objective: To assess the infertility rate after laparoscopic ileal pouch-anal anastomosis (IPAA). Background: Total proctocolectomy with IPAA is known to be associated with postoperative infertility in open surgery, which may be caused by pelvic adhesions affecting the fallopian tubes. However, fertility after laparoscopic IPAA has never been assessed. Methods: All patients who underwent a total laparoscopic IPAA between 2000 and 2011 and were aged 45 years or less at the time of operation and 18 years or more at the time of data collection were included. The patients answered a fertility questionnaire by telephone. All demographic and perioperative data were prospectively collected. The results were compared with those of controls undergoing laparoscopic appendectomy. Results: Sixty-three patients were included. The mean age at the time of surgery was 31 ± 9 years (range 14–44). IPAA was performed for ulcerative colitis in 73% of the cases and familial adenomatous polyposis in 17%. The mean follow-up after IPAA was 68 ± 33 months (range 6–136). Fifty-six patients answered the questionnaire (89%). Half of them already had a child before IPAA. Fifteen patients attempted pregnancy after IPAA, of which 11 (73%) were able to conceive, resulting in 10 ongoing pregnancies and 1 miscarriage. The global infertility rate was 27%. There was no difference in fertility over time compared with the 14 controls who attempted pregnancy during the same period (90% vs 86% at 36 months, P = 0.397). Conclusions: The infertility rate appears to be lower after laparoscopic IPAA than after open surgery

Post-discharge follow-up using text messaging within an enhanced recovery program after colorectal surgery

INTRODUCTION: Enhanced recovery after surgery programs (ERP) often lead to early discharge and return to home. In terms of risk management, extended surveillance is recommended. Surveillance using text messages (TM) has been validated for minor operations in ambulatory surgery. The goal of this study was to evaluate the feasibility of home surveillance by TM after colorectal surgery within an ERP. METHODS: This prospective multicenter study involved the University hospitals of Clermont-Ferrand, Grenoble, Marseille and Lyon Sud between November 2014 and September 2015. All patients underwent colorectal surgery within an ERP. Post-discharge, patients received TM (4 simple questions with regard to pain, bowel movements, temperature and phlebitis) on days 1, 3 and 5. If there was abnormal or lack of response, an automatic alert was sent to the attending physician via Internet and the patient was contacted immediately. RESULTS: One hundred and eleven patients were included. Responses were obtained within a median of 12 (1-422) minutes, and 90% of patients answered all TM. There were 48 alerts: 56% because of pain and 40% due to absence of response to the TM. Alerts led to in-hospital care for 4% of patients including three re-hospitalizations and two unplanned re-operations. The median satisfaction score (85% of patients responded) was 5 on a scale of 1 to 5. CONCLUSION: This study suggests the possibility, as for ambulatory surgery, to use test messaging for post-discharge home surveillance for patients undergoing colorectal surgery within an ERP.La réhabilitation améliorée après chirurgie (RAC) aboutit souvent à un retour précoce à domicile. En termes de gestion des risques liés à cette prise en charge une prolongation de la surveillance à domicile est recommandée. La surveillance par SMS est validée en chirurgie ambulatoire pour des interventions dites mineures. L'objectif de cette étude était d'évaluer la faisabilité d'une surveillance par SMS à domicile après chirurgie colorectale dans le cadre d'un programme de réhabilitation améliorée

Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch- anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271)

International audienceBackground: There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD

Laparoscopic Approach Is feasible in Crohn’s Complex Enterovisceral Fistulas: A Case-Match Review

Complex enterovisceral fistulas are internal fistulas joining a “diseased” organ to any intraabdominal “victim” organ, with the exception of ileoileal fistulas. Few publications have addressed laparoscopic surgery for complex fistulas in Crohn’s disease. The aim of this study was to evaluate the feasibility of such an approach. All patients who underwent a laparoscopic ileocecal resection for complex enterovisceral fistulas between January 2004 and August 2011 were included. They were matched to a control group undergoing operation for nonfistulizing Crohn’s disease according to age, sex, nutritional state, preoperative use of steroids, and type of resection performed. Matching was performed blind to the peri- and postoperative results of each patient. The 2 groups were compared in terms of operative time, conversion to open surgery, morbidity and mortality rates, and length of stay. RESULTS: Eleven patients presenting with 13 complex fistulas were included and matched with 22 controls. Group 1 contained 5 ileosigmoid fistulas (38%), 3 ileotransverse fistulas (23%), 3 ileovesical fistulas (23%), 1 colocolic fistula (8%), and 1 ileosalpingeal fistula (8%). There were no significant differences between the groups in terms of operative time (120 (range, 75–270) vs 120 (range, 50–160) minutes, p = 0.65), conversion to open surgery (9% vs 0%, p = 0.33), stoma creation (9% vs 14%, p = 1), global postoperative morbidity (18% vs 32%, p = 0.68), and major complications (Dindo III: 0% vs 9%, p = 0.54; Dindo IV: 0% vs 0%, p = 1), as well as in terms of length of stay (8 (range, 7–32) vs 9 (range, 5–17) days, p = 0.72). No patients died. A laparoscopic approach for complex fistulas is feasible in Crohn’s disease, with outcomes similar to those reported for nonfistulizing forms