This trial is active, not recruiting.

Conditions obesity, diabetes, hypertension
Treatments laparoscopic biliopancreatic diversion with duodenal switch, laparoscopic roux-en-y gastric bypass
Phase phase 4
Sponsor Göteborg University
Collaborator Helse Sor-Ost
Start date April 2006
End date December 2016
Trial size 60 participants
Trial identifier NCT00327912, SU688-02


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Laparoscopic Biliopancreatic diversion with Duodenal switch
laparoscopic biliopancreatic diversion with duodenal switch
(Active Comparator)
Laparoscopic Roux-en-Y Gastric Bypass
laparoscopic roux-en-y gastric bypass

Primary Outcomes

time frame: 5 y
Metabolic normalization
time frame: 5y
Gastro-intestinal side effects
time frame: 5y

Secondary Outcomes

Health economics
time frame: 5y
Vitamin/mineral deficiencies
time frame: 5y
Body composition
time frame: 5y
Quality of life
time frame: 5y
Eating pattern
time frame: 5y

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

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

Additional Information

Official title Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Göteborg University.