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

Obesity Clinical Trial

— ASGARD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00327912
• Other study ID #: SU688-02
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 18, 2006
• Last updated: February 1, 2017
• Start date: April 2006
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Procedure:
• Laparoscopic Biliopancreatic diversion with Duodenal switch

• Laparoscopic Roux-en-Y Gastric Bypass

Locations

Country	Name	City	State
Norway	Dept of Surgery, Aker University Hospital	Oslo
Sweden	Dept of Surgery, Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Helse Sor-Ost

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		5 y
Primary	Metabolic normalization		5y
Primary	Gastro-intestinal side effects		5y
Secondary	Health economics		5y
Secondary	Vitamin/mineral deficiencies		5y
Secondary	Body composition		5y
Secondary	Quality of life		5y
Secondary	Eating pattern		5y