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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327912
First Posted: May 19, 2006
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Göteborg University
  Purpose
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
Obesity Diabetes Hypertension 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: None (Open Label)
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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327912


Locations
Norway
Dept of Surgery, Aker University Hospital
Oslo, Norway
Sweden
Dept of Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00327912     History of Changes
Other Study ID Numbers: SU688-02
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by Göteborg University:
Obesity
Surgery
Gastric bypass
Biliopancreatic diversion with Duodenal switch
Laparoscopy