Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
NCT ID: NCT01514799
Last Updated: 2020-02-25
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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COMPLETED
NA
140 participants
INTERVENTIONAL
2011-08-29
2020-02-01
Brief Summary
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The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.
Endpoints are quality of life, gastrointestinal function, and weight development.
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Detailed Description
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Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.
Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.
FU time is set at 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Code number in operative charts.
Study Groups
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standard length bp limb, long alimentary limb
our normal way of doing a gastric bypass 60 cm BP limb
gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
Long BP limb
200 cm BP limb
gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
Interventions
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gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
Eligibility Criteria
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Inclusion Criteria
* Age 18-55
* Conservative attempts at weight reduction failed
Exclusion Criteria
* Residence outside the county of Skåne
* Psychotic disease
* Inflammatory bowel disease
18 Years
55 Years
ALL
No
Sponsors
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Aleris Obesity
INDUSTRY
Responsible Party
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Principal Investigators
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Jan L Hedenbro
Role: PRINCIPAL_INVESTIGATOR
Lunds Universitets Diabetescentrum
Locations
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Aleris Obesity Skåne
Lund, , Sweden
Countries
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References
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Nergard BJ, Leifson BG, Gislason H, Hedenbro JL. Effect of different limb lengths on quality of life, eating patterns and gastrointestinal symptoms after Roux-en-Y gastric bypass in superobese patients: randomized study. BJS Open. 2020 Sep 15;4(6):1109-16. doi: 10.1002/bjs5.50334. Online ahead of print.
Nergard BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2.
Other Identifiers
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2011_HG_Aleris_limb_length
Identifier Type: -
Identifier Source: org_study_id
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