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

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ClinicalTrials.gov Identifier: NCT00327912
Recruitment Status : Unknown
Verified February 2017 by Göteborg University.
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2006
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Göteborg University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Obesity Diabetes Hypertension Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch Procedure: Laparoscopic Roux-en-Y Gastric Bypass Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : April 2006
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. BMI [ Time Frame: 5 y ]
  2. Metabolic normalization [ Time Frame: 5y ]
  3. Gastro-intestinal side effects [ Time Frame: 5y ]

Secondary Outcome Measures :
  1. Health economics [ Time Frame: 5y ]
  2. Vitamin/mineral deficiencies [ Time Frame: 5y ]
  3. Body composition [ Time Frame: 5y ]
  4. Quality of life [ Time Frame: 5y ]
  5. Eating pattern [ Time Frame: 5y ]

Eligibility Criteria
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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
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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
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00327912    
Other Study ID Numbers: SU688-02
First Posted: May 19, 2006    Key Record Dates
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
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight