Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study (BMI>50)
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|ClinicalTrials.gov Identifier: NCT02033577|
Recruitment Status : Unknown
Verified March 2015 by Jan Hedenbro, Aleris Obesity.
Recruitment status was: Recruiting
First Posted : January 13, 2014
Last Update Posted : March 17, 2015
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.
Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
|Condition or disease||Intervention/treatment||Phase|
|Severe Obesity||Procedure: Distal gastrojejunal bypass Procedure: RYGB||Not Applicable|
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.
Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: Distal gastrojejunal bypass
RYGB with 200 cm BP limb and 150 cm common limb
Procedure: Distal gastrojejunal bypass
RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
Active Comparator: RYGB
RYGB with 60 cm BP limb and 150 cm alimentary limb
RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on
- Body weight reduction [ Time Frame: 2 years from end of inclusion ]Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
- Patient assessed quality of life [ Time Frame: 2 years from end of inclusion ]We employ SF-36, Op-9, GSRS, TFEQ scales
- Short-term complications [ Time Frame: 0-30 days postoperatively ]Time to discharge, leaks, bleeding
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): NCT02033577
|Contact: Jan Hedenbro, MD,PhDfirstname.lastname@example.org|
|Contact: Hjortur G Gislason, MD,PhDemail@example.com|
|Contact: Bent Johnny Nergaard, MD +4792861730 firstname.lastname@example.org|
|Contact: Jan Hedenbro|
|Sub-Investigator: Bent Johnny Nergaard, MD|