Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study

Aleris Obesity

Status: Completed

Conditions: Weight Loss; Morbid Obesity

Treatments: Procedure: gastric bypass

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514799

2011_HG_Aleris_limb_length

Details and patient eligibility

About

Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.

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.

Full description

Two variations of gastric bypass are compared:

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI 50-65
• Age 18-55
• Conservative attempts at weight reduction failed

Exclusion criteria

• Inability to speak and understand the Swedish language
• Residence outside the county of Skåne
• Psychotic disease
• Inflammatory bowel disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

standard length bp limb, long alimentary limb

Active Comparator group

Description:

our normal way of doing a gastric bypass 60 cm BP limb

Treatment:

Procedure: gastric bypass

Long BP limb

Experimental group

Description:

200 cm BP limb

Treatment:

Procedure: gastric bypass