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Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study (BMI>50)

A

Aleris Obesity

Status

Unknown

Conditions

Severe Obesity

Treatments

Procedure: RYGB
Procedure: Distal gastrojejunal bypass

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02033577
NCT01514799

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI > 50

Exclusion criteria

  • Psychiatric disease
  • Inflammatory bowel disease
  • inability to understand Swedish

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

Distal gastrojejunal bypass
Experimental group
Description:
RYGB with 200 cm BP limb and 150 cm common limb
Treatment:
Procedure: Distal gastrojejunal bypass
RYGB
Active Comparator group
Description:
RYGB with 60 cm BP limb and 150 cm alimentary limb
Treatment:
Procedure: RYGB

Trial contacts and locations

1

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Central trial contact

Hjortur G Gislason, MD,PhD; Jan Hedenbro, MD,PhD

Data sourced from clinicaltrials.gov

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