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

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ClinicalTrials.gov Identifier: NCT04788199
Recruitment Status : Completed
First Posted : March 9, 2021
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed Ghanem, Mansoura University

Study Description
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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.

Condition or disease Intervention/treatment
Bariatric Surgery Other: Closure of mesenteric defects using 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.

Study Design
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Study Type : Observational
Actual Enrollment : 928 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Analytical Study of Internal Hernia Following Laparoscopic Roux-eny Gastric Bypass
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Non-closure group
Group in which mesenteric defects were not closed after laparoscopic Roux-en-Y gastric bypass.
Closure group
Group in which mesenteric defects were closed using cyano-acrylate glue after laparoscopic Roux-en-Y gastric bypass.
 Other: Closure of mesenteric defects using glue
Cyano-acrylate glue is a glue known to be used in surgery as tissue adhesive.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass [ Time Frame: September 2007 to January 2020 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with morbid obesity who were qualified to receive LRYGB in the period between September 2007 and January 2020
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788199


Locations
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United Kingdom
St. Mary's Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed Ghanem Mansoura Faculty of Medicine, Imperial College Healthcare NHS Trust
More Information
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Responsible Party: Ahmed Ghanem, Principal Investigator / As. Lecturer of General Surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT04788199    
Other Study ID Numbers: R / 17.11.105
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Ghanem, Mansoura University:
Bypass, Gastric; Obesity, Morbid; Glue. Internal hernia; Laparoscopy.
Additional relevant MeSH terms:
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Hernia
Internal Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical