Patients
fistula
SECONDARY, RECTAL CANCER, COMPLICATIONS
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 and August 2022). The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 10027/26-10-2022) and was retrospectively submitted in clinical trials.gov in November 2022 (ClinicalTrials.gov ID: NCT05659446). The investigators performed the study under the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. Written informed consent was obtained from all study participants. Patients with recurrent low output colo-cutaneous fistula (less than 500 cc/24 h) or leak after anterior resection due to rectal cancer, patients with unsuccessful conservative measures, patient with good general condition (ASA I and II), patients with size of fistula less than 15 mm and patients with good nutritional status were included and eligible for randomization. The investigators excluded patients who were in 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 15 mm or patients who were successfully managed with conservative measures.Included eligible patients were simply randomized at a 1:1 ratio to “Endoscopic (EG)” or “Surgical Group (SG)” 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 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 of managing the fistula, length of postoperative hospital stay, and complications and mortality in each group after the intervention during the 3-months follow-up period, respectively. The clinical data of the patients was stored in hard drive that was protected by a password.