Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

March 31, 2020 updated by: Sara Kristensen, Region Zealand

Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Bariatric clinic, Department of Surgery, Køge hospital
    • Sealand
      • Køge, Sealand, Denmark, 4600
        • Department of Surgery;Bariatric Clinic, Køge Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who meet the requirements for a Gastric Bypass at Køge Hospital.

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria
  • Patients who converted to open surgeon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inertervention group_Clips to avoid internal herniation
LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation.
Procedure: Closing the mesenteric defects with clips during opration
The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).
Other Names:
  • Clips, Herniestapler, Internal hernia, Gastric bypass
No Intervention: Control group
conventional LRYGB without closure of the mesenteric defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To avoid the risk of Internal Hernias in patient with a Gastric bypass
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain score (VAS)
Time Frame: 5 years
5 years
Operative time consumption, the amount of clips, trocar and sutures used
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 days complication
Time Frame: 3 years

30 days complications:

  • Anastomotic leak
  • Bleeding (Hb)
  • Blood transfusions (MAF)
  • Ileus due to kinking, blowout of the bypassed stomach
  • Intraperitoneal abscesses.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Zealand

Investigators

  • Principal Investigator: Sara Kristensen, Doctor, Department of Surgery, Bariatric Clinic, Koge Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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