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Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy l

NCT04879667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-10

No results posted yet for this study

Summary

This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. The study was approved by the research and Ethics committee of investigators' University .a written informed consent was obtained from all participating patients after explaining to them all the study procedures with its benefits and hazards. the work has been carried out in accordance with the code of ethics of the world medical association ( Declaration of Helsinki ) for studies involving humans .the sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of refractory gastro-cutaneous fistula by surgical intervention 50% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.

Conditions

  • Bariatric Surgery Candidate

Interventions

PROCEDURE

endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy

we performed upper GI endoscopy to all cases first to assess the site , size and cause of fistula . we used stents , clips , sutures and ballon dilatation to close the fistula according to size , site and cause of fistula.if the fistula had no track that was proved by CT with oral \& I.V contrast , we used the endoscopic stent. if the fistula had track that was proved by CT with oral \& I.V contrast , we used the OVASCO clip , endo suturing or ballon. Combined maneuvers may be used like ballon dilation and clipping or ballon dilatation and suturing if there was distal narrowing.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Said Mohamed Negm, MD · ZAGAZIG UNIVERSITY HOSPITALS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2021-03-01
Completion
2021-04-01

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 NCT04879667 on ClinicalTrials.gov