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

This study is ongoing, but not recruiting participants.
Helse Sor-Ost
Information provided by (Responsible Party):
Göteborg University Identifier:
First received: May 18, 2006
Last updated: February 1, 2017
Last verified: February 2017
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).

Condition Intervention Phase
Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
Procedure: Laparoscopic Roux-en-Y Gastric Bypass
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • BMI [ Time Frame: 5 y ]
  • Metabolic normalization [ Time Frame: 5y ]
  • Gastro-intestinal side effects [ Time Frame: 5y ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00327912

Dept of Surgery, Aker University Hospital
Oslo, Norway
Dept of Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Helse Sor-Ost
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Göteborg University Identifier: NCT00327912     History of Changes
Other Study ID Numbers: SU688-02
Study First Received: May 18, 2006
Last Updated: February 1, 2017

Keywords provided by Göteborg University:
Gastric bypass
Biliopancreatic diversion with Duodenal switch
Laparoscopy processed this record on March 29, 2017