Internal Hernia After Laparoscopic Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137201
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
Erik Stenberg, MD, Region Örebro County

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

Condition or disease Intervention/treatment Phase
The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure. Procedure: Suturing of mesenteric defects Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internal Hernia After Laparoscopic Gastric Bypass
Study Start Date : May 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mesenteric defects sutured
Closure of the mesenteric defects using running, non-absorbable suture
Procedure: Suturing of mesenteric defects
No Intervention: Mesenteric defects not sutured
Non-closure of the mesenteric defects

Primary Outcome Measures :
  1. Surgery for small bowel obstruction after a LGBP procedure. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Serious Complications [ Time Frame: within 2 years after surgery ]
    Defined as Clavien grade 3b or more

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137201

Department of Surgery, Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Region Örebro County
Study Director: Ingmar Näslund, MD, PhD Scandinavian Obesity Surgery Registry

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erik Stenberg, MD, MD, Region Örebro County Identifier: NCT01137201     History of Changes
Other Study ID Numbers: EPN 2009/415
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Erik Stenberg, MD, Region Örebro County:
Small bowel obstruction
Laparoscopic gastric bypass
Internal Hernia
Mesenteric defect
Morbid obesity

Additional relevant MeSH terms:
Intestinal Obstruction
Hernia, Abdominal
Pathological Conditions, Anatomical
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases