Clinical trial · Interventional
Endoscopic Management Of Low Output Recurrent Colonic Fistula Or Leak After Anterior Resection For Rectal Cancer
Endoscopic Management Of Low Output Recurrent Colonic Fistula Or Leak After Anterior Resection For Rectal Cancer: A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Fistula | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopy management of low output colonic fistula or leak after anterior resection for rectal cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- endoscopic group
- description
- 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.
- interventionNames
- Procedure: endoscopy management of low output colonic fistula or leak after anterior resection for rectal cancer
- type
- NO_INTERVENTION
- label
- surgical group
- description
- Patients involved in surgical group were subjected to either redo of resection anastomosis manually or by circular stapler or primary repair of the defect with ileostomy. This was done under general anesthesia after colonic preparation.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 * patients with good nutritional status Exclusion 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 15mm * patients were treated with conservative measures.
References
Publications (1)
- DERIVEDNegm S, Farag A, Shafiq A, Allah EA, Shehata M, Orban YA, Saleh M, Abdelghani AA. Endoscopic management of low output recurrent colonic fistula or leak after anterior resection for rectal cancer: a randomized controlled trial. Surg Endosc. 2023 Aug;37(8):6145-6152. doi: 10.1007/s00464-023-10092-z. Epub 2023 May 5. PMID 37145174