Patients
gastric leak, fistula
MAY, SECONDARY, RECURRENCE
We included all bariatric patients who developed gastric leak or fistula after LSG either performed at the Department of Surgery, Zagazig University Faculty of Medicine or referred to our department between December 2019 and March 2021. While all included patients were of the American Society of Anesthesiologists (ASA) Physical status I–II, patients with ASA status III–IV or those who demonstrated a satisfactory response to the conservative measures were excluded (Patients with physical status III and IV were managed according to their general, condition, clinical status and radiological and endoscopic findings either by conservative measures or surgery). This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 11130/2.12.2019) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. This study was retrospectively submitted in clinicaltrials.gov in May 2021 (NCT04879667). Written informed consent was obtained from all participants after explaining to them all the study procedures with its benefits and hazards.Included patients were randomized at a 1:1 ratio to “Surgery Group, SG” or “Endoscopic Group” via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention. Sample size was calculated using open Epi program using the following data: confidence interval 95%, power of test 80%, ratio of unexposed/exposed 1, percent of patients with successful management of persistent gastric leak or fistula by surgical intervention 50% and those with successful management by endoscopy 99%, odds ratio 99%, and risk ratio 2.Primary and secondary outcomes were recurrence of the fistula and mortality in each group after the intervention during the 3 months follow-up period, respectively.