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Endoscopic Management Of Low Output Recurrent Colonic Fistula Or Leak After Anterior Resection For Rectal Cancer

NCT05659446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

  • Colonic Fistula

Interventions

PROCEDURE

endoscopy management of low output colonic fistula or leak after anterior resection for rectal cancer

Patients involved in endoscopic group were firstly subjected for Interventional Radiology to drain any intra-peritoneal collection present in preoperative radiology then were subjected either to Clips application (OTSC, OVASCO Endoscopy AG. Tubingen, Germany) or Endo-suturing (Overstitch, Apollo Endo-Surgery , TX, United states) to close the low output fistula or leak after anterior resection for rectal cancer. The endoscopy was done under sedation, not general anesthesia after colonic preparation (chemical \& mechanical preparation) firstly, to detect size of fistula . Clips were used in cases with fistula's size less than 10 mm, while Endo-suturing devices were used in cases with fistula's size more than 10mm till 15mm.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Said Mohamed Negm · Zagazig University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2022-05-10
Completion
2022-08-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05659446 on ClinicalTrials.gov