Internal Hernia After Laparoscopic Gastric Bypass

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Erik Stenberg, MD, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01137201
First received: June 2, 2010
Last updated: January 17, 2013
Last verified: January 2013

June 2, 2010
January 17, 2013
May 2010
March 2014   (final data collection date for primary outcome measure)
Surgery for small bowel obstruction after a LGBP procedure. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
The prevalence of surgery for obstruction after a LGBP procedure. [ Time Frame: 3 years ]
Complete list of historical versions of study NCT01137201 on ClinicalTrials.gov Archive Site
Serious Complications [ Time Frame: within 2 years after surgery ] [ Designated as safety issue: Yes ]
Defined as Clavien grade 3b or more
Not Provided
Not Provided
Not Provided
 
Internal Hernia After Laparoscopic Gastric Bypass
Internal Hernia After Laparoscopic Gastric Bypass

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
The Prevalence of Surgery for Gastrointestinal Obstruction After a LGBP Procedure.
Procedure: Suturing of mesenteric defects
  • Mesenteric defects sutured
    Closure of the mesenteric defects using running, non-absorbable suture
    Intervention: Procedure: Suturing of mesenteric defects
  • Mesenteric defects not sutured
    Non-closure of the mesenteric defects
    Intervention: Procedure: Suturing of mesenteric defects
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2508
June 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01137201
EPN 2009/415
Yes
Erik Stenberg, MD, University Hospital Orebro
University Hospital Orebro
Not Provided
Study Director: Ingmar Näslund, MD, PhD Scandinavian Obesity Surgery Registry
University Hospital Orebro
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP