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

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