NCT01137201

Internal Hernia After Laparoscopic Gastric Bypass

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,507 (actual)
• Sponsor: Region Örebro County · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Suturing of mesenteric defects

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-12-01
• Completion: 2015-11-01
• First posted: 2010-06-04
• Last updated: 2015-12-03

Locations

1 site across 1 country: Sweden