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

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

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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