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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

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

NCT ID

NCT01137201

First Posted

June 2, 2010

Last Updated

December 2, 2015

Sponsor

Region Örebro County

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

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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