Endoscopic Management Of Low Output Recurrent Colonic Fistula Or Leak After Anterior Resection For Rectal Cancer: A Randomized Controlled Trial.

This prospective randomized controlled clinical trial included all patients who developed the manifestations of low output recurrent colonic fistula or leak after colonic anterior resection for rectal cancer at Zagazig University hospital between (December 2020 to August 2022). The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 10027/26-10-2022).The investigators performed the study under the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. They got written informed consent from all participants after explaining to them all the study procedures with its benefits and hazards. Patients with recurrent low output colo-cutaneous fistula (less than 500cc/24h) or leak after anterior resection due to rectal cancer , patients who subjected to conservative measures but failed , patient with good general condition (ASA I&II), patients with size of fistula less than 15mm and patients with good nutritional status were included and eligible for randomization. The investigators excluded patients who were with bad general condition (ASAIII&IV&V), patients with high output fistula , patients with recto-vaginal or recto-vesical fistula, patients with size of fistula more than 15mm and patients were treated with conservative measures.

Included eligible patients were simply randomized at a 1:1 ratio to "Endoscopic (SG)" or "Surgical Group (EG)" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.

The sample size was calculated by using an open Epi program depending on the following data; confidence interval 95%, power of the test 80%, ratio of unexposed/ exposed 1, the success rate of endoscopic management of low output colonic fistula after anterior resection of rectal cancer versus surgical management was 60.2% versus 90% respectively . Odd ratio 0.17, and risk ratio 0.67, so the calculated sample size equal 78 patients divided into two equal groups.

Primary and secondary outcomes were success rate in managing the fistula , postoperative hospital stay, and complications and mortality in each group after the intervention during the 3-months follow-up period, respectively.

Diagnosis After full history taking and complete physical examination, low output colonic fistula or leak after anterior resection for rectal cancer was clinically suspected and then confirmed by laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile), radiological imaging (abdominal US to exclude any abdominal collection, CT abdomen with oral and I. V contrast, MRI in some situations and virtual colonoscopy to exclude any distal obstruction , distal narrowing or recurrence of the cancer ).