Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Region Zealand
Sponsor:
Information provided by (Responsible Party):
Sara Kristensen, Region Sealand
ClinicalTrials.gov Identifier:
NCT01595230
First received: May 9, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias


Condition Intervention
Internal Hernias
Procedure: Closing the mesenteric defects with clips during opration

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

Resource links provided by NLM:


Further study details as provided by Region Zealand:

Primary Outcome Measures:
  • To avoid the risk of Internal Hernias in patient with a Gastric bypass [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative pain score (VAS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Operative time consumption, the amount of clips, trocar and sutures used [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 30 days complication [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    30 days complications:

    • Anastomotic leak
    • Bleeding (Hb)
    • Blood transfusions (MAF)
    • Ileus due to kinking, blowout of the bypassed stomach
    • Intraperitoneal abscesses.


Estimated Enrollment: 500
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clips to avoid internal herniation
The aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation.
Procedure: Closing the mesenteric defects with clips during opration
The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).
Other Name: Clips, Herniestapler, Internal hernia, Gastric bypass

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who meet the requirements for a Gastric Bypass at Køge Hospital.

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria
  • Patients who converted to open surgeon
  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: NCT01595230

Contacts
Contact: Sara Kristensen, doctor +45-4732-3055 sark@regionsjaelland.dk

Locations
Denmark
Department of Surgery;Bariatric Clinic, Køge Hospital Not yet recruiting
Køge, Sealand, Denmark, 4600
Contact: Sara Kristensen, Doctor    +45-4732-3055    Sark@regionsjaelland.dk   
Principal Investigator: Sara Kristensen, Doctor         
Bariatric clinic, Department of Surgery, Køge hospital Recruiting
Køge, Denmark, 4600
Contact: Sara Kristensen, Doctor    +4547323055    sark@regionsjaeland.dk   
Sponsors and Collaborators
Region Zealand
Investigators
Principal Investigator: Sara Kristensen, Doctor Department of Surgery, Bariatric Clinic, Koge Hospital
  More Information

No publications provided by Region Zealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sara Kristensen, Doctor, Region Sealand
ClinicalTrials.gov Identifier: NCT01595230     History of Changes
Other Study ID Numbers: SJ-284
Study First Received: May 9, 2012
Last Updated: October 23, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Region Zealand:
Internal Hernias
Clips
Gastric Bypass
Avoid

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 29, 2014