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Internal Hernia After Laparoscopic Gastric Bypass

NCT ID: NCT01137201

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-11-30

Brief Summary

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To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenteric defects sutured

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

Group Type EXPERIMENTAL

Suturing of mesenteric defects

Intervention Type PROCEDURE

Mesenteric defects not sutured

Non-closure of the mesenteric defects

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Suturing of mesenteric defects

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Erik Stenberg, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingmar Näslund, MD, PhD

Role: STUDY_DIRECTOR

Scandinavian Obesity Surgery Registry

Locations

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Department of Surgery, Örebro University Hospital

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

References

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Stenberg E, Ottosson J, Magnuson A, Szabo E, Wallen S, Naslund E, Thorell A, Naslund I. Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):709-717. doi: 10.1001/jamasurg.2023.1042.

Reference Type DERIVED
PMID: 37163240 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28676957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26895675 (View on PubMed)

Other Identifiers

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EPN 2009/415

Identifier Type: -

Identifier Source: org_study_id