Internal Hernia After Laparoscopic Gastric Bypass

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

Official title:

Internal Hernia After Laparoscopic Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137201
• Other study ID #: EPN 2009/415
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: December 2, 2015
• Start date: May 2010
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and WelfareSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2507
• Est. completion date: November 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia, Abdominal
• Intestinal Obstruction
• The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.

Intervention

Procedure:
• Suturing of mesenteric defects

Locations

Country	Name	City	State
Sweden	Department of Surgery, Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery for small bowel obstruction after a LGBP procedure.		2 years	Yes
Secondary	Serious Complications	Defined as Clavien grade 3b or more	within 2 years after surgery	Yes