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Internal Hernia After Laparoscopic Gastric Bypass

Primary Purpose

The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Suturing of mesenteric defects
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure. focused on measuring Small bowel obstruction, Laparoscopic gastric bypass, Internal Hernia, Mesenteric defect, Morbid obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent

Exclusion Criteria:

  • Conversion to open surgery prior to the randomization
  • Patients not giving a written consent

Sites / Locations

  • Department of Surgery, Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mesenteric defects sutured

Mesenteric defects not sutured

Arm Description

Closure of the mesenteric defects using running, non-absorbable suture

Non-closure of the mesenteric defects

Outcomes

Primary Outcome Measures

Surgery for small bowel obstruction after a LGBP procedure.

Secondary Outcome Measures

Serious Complications
Defined as Clavien grade 3b or more

Full Information

First Posted
June 2, 2010
Last Updated
December 2, 2015
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT01137201
Brief Title
Internal Hernia After Laparoscopic Gastric Bypass
Official Title
Internal Hernia After Laparoscopic Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.
Detailed Description
When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.
Keywords
Small bowel obstruction, Laparoscopic gastric bypass, Internal Hernia, Mesenteric defect, Morbid obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenteric defects sutured
Arm Type
Experimental
Arm Description
Closure of the mesenteric defects using running, non-absorbable suture
Arm Title
Mesenteric defects not sutured
Arm Type
No Intervention
Arm Description
Non-closure of the mesenteric defects
Intervention Type
Procedure
Intervention Name(s)
Suturing of mesenteric defects
Primary Outcome Measure Information:
Title
Surgery for small bowel obstruction after a LGBP procedure.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Serious Complications
Description
Defined as Clavien grade 3b or more
Time Frame
within 2 years after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent Exclusion Criteria: Conversion to open surgery prior to the randomization Patients not giving a written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingmar Näslund, MD, PhD
Organizational Affiliation
Scandinavian Obesity Surgery Registry
Official's Role
Study Director
Facility Information:
Facility Name
Department of Surgery, Örebro University Hospital
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28676957
Citation
Stenberg E, Szabo E, Ottosson J, Thorell A, Naslund I. Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial. Obes Surg. 2018 Jan;28(1):31-36. doi: 10.1007/s11695-017-2798-z.
Results Reference
derived
PubMed Identifier
26895675
Citation
Stenberg E, Szabo E, Agren G, Ottosson J, Marsk R, Lonroth H, Boman L, Magnuson A, Thorell A, Naslund I. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial. Lancet. 2016 Apr 2;387(10026):1397-1404. doi: 10.1016/S0140-6736(15)01126-5. Epub 2016 Feb 16.
Results Reference
derived

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Internal Hernia After Laparoscopic Gastric Bypass

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