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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595230
Recruitment Status : Active, not recruiting
First Posted : May 10, 2012
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Sara Kristensen, Region Zealand

Brief Summary:
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 or disease Intervention/treatment Phase
Internal Hernias Procedure: Closing the mesenteric defects with clips during opration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : May 2012
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Inertervention group_Clips to avoid internal herniation
LRYGB with closure of the defects with simple hernia stapler clips. 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

No Intervention: Control group
conventional LRYGB without closure of the mesenteric defects



Primary Outcome Measures :
  1. To avoid the risk of Internal Hernias in patient with a Gastric bypass [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Postoperative pain score (VAS) [ Time Frame: 5 years ]
  2. Operative time consumption, the amount of clips, trocar and sutures used [ Time Frame: 3 years ]

Other Outcome Measures:
  1. 30 days complication [ Time Frame: 3 years ]

    30 days complications:

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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595230


Locations
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Denmark
Department of Surgery;Bariatric Clinic, Køge Hospital
Køge, Sealand, Denmark, 4600
Bariatric clinic, Department of Surgery, Køge hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Region Zealand
Investigators
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Principal Investigator: Sara Kristensen, Doctor Department of Surgery, Bariatric Clinic, Koge Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sara Kristensen, Doctor, Region Zealand
ClinicalTrials.gov Identifier: NCT01595230    
Other Study ID Numbers: SJ-284
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Keywords provided by Sara Kristensen, Region Zealand:
Internal Hernias
Clips
Gastric Bypass
Avoid
Additional relevant MeSH terms:
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Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical