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

NCT ID: NCT04788199

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

928 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-closure group

Group in which mesenteric defects were not closed after laparoscopic Roux-en-Y gastric bypass.

No interventions assigned to this group

Closure group

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

Closure of mesenteric defects using glue

Intervention Type OTHER

Cyano-acrylate glue is a glue known to be used in surgery as tissue adhesive.

Interventions

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Closure of mesenteric defects using glue

Cyano-acrylate glue is a glue known to be used in surgery as tissue adhesive.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ghanem

Principal Investigator / As. Lecturer of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Ghanem

Role: PRINCIPAL_INVESTIGATOR

Mansoura Faculty of Medicine, Imperial College Healthcare NHS Trust

Locations

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St. Mary's Hospital, Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R / 17.11.105

Identifier Type: -

Identifier Source: org_study_id

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