Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
NCT ID: NCT01595230
Last Updated: 2020-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
405 participants
INTERVENTIONAL
2012-05-31
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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).
Control group
conventional LRYGB without closure of the mesenteric defects
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who converted to open surgeon
18 Years
85 Years
ALL
No
Sponsors
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Region Zealand
OTHER
Responsible Party
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Sara Kristensen
Doctor
Principal Investigators
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Sara Kristensen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Bariatric Clinic, Koge Hospital
Locations
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Department of Surgery;Bariatric Clinic, Køge Hospital
Køge, Sealand, Denmark
Bariatric clinic, Department of Surgery, Køge hospital
Køge, , Denmark
Countries
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References
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Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.
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.
Other Identifiers
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SJ-284
Identifier Type: -
Identifier Source: org_study_id
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