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

Phase 4

• Conditions: Obesity; Diabetes; Hypertension
• Interventions: Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch; Procedure: Laparoscopic Roux-en-Y Gastric Bypass

• Registration Number: NCT00327912
• Lead Sponsor: Göteborg University

Brief 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-18
• Study First Submitted QC: 2006-05-18
• Study First Posted: 2006-05-19
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Laparoscopic Biliopancreatic diversion with Duodenal switch	Laparoscopic Biliopancreatic diversion with Duodenal switch
2	Laparoscopic Roux-en-Y Gastric Bypass	Laparoscopic Roux-en-Y Gastric Bypass

Primary Outcome Measures

Name	Time	Method
BMI	5 y
Metabolic normalization	5y
Gastro-intestinal side effects	5y

Secondary Outcome Measures

Name	Time	Method
Health economics	5y
Vitamin/mineral deficiencies	5y
Body composition	5y
Quality of life	5y
Eating pattern	5y

Trial Locations

Locations (2)

Dept of Surgery, Aker University Hospital; 🇳🇴 Oslo, Norway

Dept of Surgery, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden