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Completed
NCT05659446
Endoscopic Management Of Low Output Recurrent Colonic Fistula Or Leak After Anterior Resection For Rectal Cancer
Conditions: Colonic Fistula
Sex: All
Healthy volunteers: 1
Phase: NA
Enrollment: 78
Sponsor: Zagazig University
Location: Egypt
Summary
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.
Eligibility Criteria
Inclusion Criteria:Patients with recurrent low output colo-cutaneous fistula (less than 500cc/24h) or leak after anterior resection due to rectal cancerpatients who subjected to conservative measures but failedpatient with good general condition (ASA I&II),patients with size of fistula less than 15mmpatients with good nutritional statusExclusion Criteria:patients 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 15mmpatients were treated with conservative measures.
Source: ClinicalTrials.gov (NCT05659446). StuddyBuddy aggregates publicly available trial information.
