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

NCT04879667 | Completed

• 1 other identifier: Zagazig University Hospitalis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• incidence of recurrence of fistula

  within one week after the endoscopy

Secondary Outcomes (1)

• incidence of side effects of endoscopy

  within one month after the endoscopy

Study Arms (2)

group (1)

NO INTERVENTION

surgical management of gastrocutaneous fistula after laparoscopic sleeve gatrectomy by surgical exploration

group (2)

ACTIVE COMPARATOR

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.

Procedure: endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy

Interventions

endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy PROCEDURE

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.

group (2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy.
• patients with ASA I \& II.

You may not qualify if:

• Any patient complicated with gastrocutaneous fistula after laparoscopic sleeve gastrectomy and managed by conservative measures.
• Patients with bad general condition ASAIII.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Egypt

Location

Related Publications (1)

• Negm S, Mousa B, Shafiq A, Abozaid M, Allah EA, Attia A, AbdelKader T, Farag A. Endoscopic management of refractory leak and gastro-cutaneous fistula after laparoscopic sleeve gastrectomy: a randomized controlled trial. Surg Endosc. 2023 Mar;37(3):2173-2181. doi: 10.1007/s00464-022-09748-z. Epub 2022 Nov 3.

  PMID: 36326931 DERIVED

Study Officials

• Said Mohamed Negm, MD

  ZAGAZIG UNIVERSITY HOSPITALS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: 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 sample size was 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.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: December 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)