NCT00327912

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

Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Obesity
• Diabetes
• Hypertension

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Biliopancreatic diversion with Duodenal switch
PROCEDURE	Laparoscopic Roux-en-Y Gastric Bypass

Timeline

• Start date: 2006-04-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2006-05-19
• Last updated: 2017-02-02

Locations

2 sites across 2 countries: Norway, Sweden