Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy ; A Randomized Control Trial

This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. The study was approved by the research and Ethics committee of investigators' University .a written informed consent was obtained from all participating patients after explaining to them all the study procedures with its benefits and hazards. the work has been carried out in accordance with the code of ethics of the world medical association ( Declaration of Helsinki ) for studies involving humans .the 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 refractory gastro-cutaneous fistula by surgical intervention 50% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.

Inclusion criteria:

Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy. patients with ASA I & II.

Exclusion criteria:

Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy and managed by conservative measures. Patients with bad general condition ASAIII.