Internal Hernia After Laparoscopic Gastric Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erik Stenberg, MD, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01137201
First received: June 2, 2010
Last updated: December 2, 2015
Last verified: December 2015
  Purpose
To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.

Condition Intervention
The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.
Procedure: Suturing of mesenteric defects

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internal Hernia After Laparoscopic Gastric Bypass

Resource links provided by NLM:


Further study details as provided by Region Örebro County:

Primary Outcome Measures:
  • Surgery for small bowel obstruction after a LGBP procedure. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serious Complications [ Time Frame: within 2 years after surgery ] [ Designated as safety issue: Yes ]
    Defined as Clavien grade 3b or more


Enrollment: 2507
Study Start Date: May 2010
Study Completion Date: November 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137201

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik Stenberg, MD, MD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01137201     History of Changes
Other Study ID Numbers: EPN 2009/415 
Study First Received: June 2, 2010
Last Updated: December 2, 2015
Health Authority: Sweden: The National Board of Health and Welfare
Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on July 26, 2016