NCT04788199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
928

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

March 4, 2021

Last Update Submit

March 6, 2021

Conditions

Bariatric Surgery

Keywords

Bypass, Gastric; Obesity, Morbid; Glue. Internal hernia; Laparoscopy.

Outcome Measures

Primary Outcomes (1)

  • Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass

    September 2007 to January 2020

Study Arms (2)

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

Interventions

Closure of mesenteric defects using glueOTHER

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

Closure group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with morbid obesity who were qualified to receive LRYGB in the period between September 2007 and January 2020

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Ghanem

    Mansoura Faculty of Medicine, Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / As. Lecturer of General Surgery

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 9, 2021

Study Start

June 15, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)