Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity (ASGARD)

Göteborg University

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Diabetes; Obesity

Treatments: Procedure: Laparoscopic Roux-en-Y Gastric Bypass; Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch

Study type: Interventional

Funder types: Other

Identifiers

NCT00327912

SU688-02

Details and patient eligibility

About

The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2).

Full description

Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting.

Superobesity (BMI > 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity.

This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI 50-60 kg/m2

Exclusion criteria

• Prior obesity operation
• Prior major abdominal surgical procedure
• Severe disabling cardiopulmonary disease
• Malignancy
• Oral steroid treatment
• Condition associated with poor compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Laparoscopic Biliopancreatic diversion with Duodenal switch

Treatment:

Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch

2

Active Comparator group

Description:

Laparoscopic Roux-en-Y Gastric Bypass

Treatment:

Procedure: Laparoscopic Roux-en-Y Gastric Bypass