Novel Technique in Closure of Mesenteric Defects After Laparoscopic Roux-en-Y Gastric Bypass and Its Effect on Internal Hernia: a Case-control Study

Completed

• Conditions: Bariatric Surgery
• Interventions: Other: Closure of mesenteric defects using glue

• Registration Number: NCT04788199
• Lead Sponsor: Mansoura University

Brief Summary

This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue.

Detailed Description

Background Internal hernia complicated by bowel obstruction is a well-recognized complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study aims to investigate the role of cyanoacrylate glue in the prevention of internal hernia (IH) after LRYGB and compare it with the open technique of managing mesenteric defects by leaving the mesentery intact without closure of mesenteric defects. Data from six UK hospitals have been involved in this study. Operations were done under the supervision of a single senior consultant surgeon of bariatric surgery.

Methods The prospectively collected data of 813 patients with morbid obesity who underwent LRYGB were retrospectively analyzed. Patients were subdivided into two groups: group I comprising 185 patients who had the mesenteric defects closed with cyanoacrylate glue and group II comprising 628 patients who were managed by the open technique of leaving the mesentery intact without closure of the mesenteric defects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-15
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-06
• Last Update Submitted: 2021-03-06
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 928

Inclusion Criteria

• All patients who underwent antecolic LRYGB without closure of mesenteric defects using cyanoacrylate glue or without closure of the mesenteric defects.

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Exclusion Criteria

• Open RYGB, laparoscopic converted to open RYGB, laparoscopic retro-colic RYGB, laparoscopic ante-colic RYGB with closure of the defect using sutures or RYGB done for non-bariatric purposes e.g. idiopathic gastroparesis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Closure group	Closure of mesenteric defects using glue	Group in which mesenteric defects were closed using cyano-acrylate glue after laparoscopic Roux-en-Y gastric bypass.

Primary Outcome Measures

Name	Time	Method
Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass	September 2007 to January 2020

Trial Locations

Locations (1)

St. Mary's Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom