Clinical Trial: Internal Hernia After Laparoscopic Gastric Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Internal Hernia After Laparoscopic Gastric Bypass

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

Detailed Summary: 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.
Sponsor: Region Örebro County

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

Original Primary Outcome: The prevalence of surgery for obstruction after a LGBP procedure. [ Time Frame: 3 years ]

Current Secondary Outcome: Serious Complications [ Time Frame: within 2 years after surgery ]

Original Secondary Outcome:

Information By: Region Örebro County

Dates:
Date Received: June 2, 2010
Date Started: May 2010
Date Completion:
Last Updated: December 2, 2015
Last Verified: December 2015