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NCT04788199 Clinical Trial

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

Bariatric Surgery Clinical Trial

Official title:
Analytical Study of Internal Hernia Following Laparoscopic Roux-eny Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04788199
Other study ID # R / 17.11.105
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2018
Est. completion date January 31, 2020

Study information
Verified date March 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 928
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients who underwent antecolic LRYGB without closure of mesenteric defects using cyanoacrylate glue or without closure of the mesenteric defects. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Closure of mesenteric defects using glue
Cyano-acrylate glue is a glue known to be used in surgery as tissue adhesive.

Locations
Country Name City State
United Kingdom St. Mary's Hospital, Imperial College Healthcare NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass September 2007 to January 2020
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