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

February 1, 2017 updated by: Göteborg University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Dept of Surgery, Aker University Hospital
  • Sweden
      • Gothenburg, Sweden, 41345
        • Dept of Surgery, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Laparoscopic Biliopancreatic diversion with Duodenal switch
Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
ACTIVE_COMPARATOR: 2
Laparoscopic Roux-en-Y Gastric Bypass
Procedure: Laparoscopic Roux-en-Y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI
Time Frame: 5 y
5 y
Metabolic normalization
Time Frame: 5y
5y
Gastro-intestinal side effects
Time Frame: 5y
5y

Secondary Outcome Measures

Outcome Measure
Time Frame
Health economics
Time Frame: 5y
5y
Vitamin/mineral deficiencies
Time Frame: 5y
5y
Body composition
Time Frame: 5y
5y
Quality of life
Time Frame: 5y
5y
Eating pattern
Time Frame: 5y
5y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Helse Sor-Ost

Investigators

  • Study Chair: Hans H Lönroth, MD, PhD, Sahlgrenska University Hospital, Sweden
  • Study Chair: Tom Mala, MD, PhD, Aker University Hospital, Oslo, Norway
  • Study Chair: Jon Kristinsson, MD, PhD, Aker University Hospital, Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (ESTIMATE)

May 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU688-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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