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

May 9, 2012
October 23, 2013
May 2012
January 2015   (final data collection date for primary outcome measure)
To avoid the risk of Internal Hernias in patient with a Gastric bypass [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01595230 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
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.
Not Provided
 
Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Internal Hernias
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
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.
Intervention: Procedure: Closing the mesenteric defects with clips during opration
Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
May 2017
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Sara Kristensen, doctor +45-4732-3055 sark@regionsjaelland.dk
Denmark
 
NCT01595230
SJ-284
No
Sara Kristensen, Region Sealand
Region Zealand
Not Provided
Principal Investigator: Sara Kristensen, Doctor Department of Surgery, Bariatric Clinic, Koge Hospital
Region Zealand
October 2013

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