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:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00327912
First received: May 18, 2006
Last updated: September 20, 2013
Last verified: September 2013

May 18, 2006
September 20, 2013
April 2006
April 2014   (final data collection date for primary outcome measure)
  • BMI [ Time Frame: 5 y ] [ Designated as safety issue: Yes ]
  • Metabolic normalization [ Time Frame: 5y ] [ Designated as safety issue: Yes ]
  • Gastro-intestinal side effects [ Time Frame: 5y ] [ Designated as safety issue: Yes ]
  • BMI
  • Metabolic normalization
  • Gastro-intestinal side effects
Complete list of historical versions of study NCT00327912 on ClinicalTrials.gov Archive Site
  • Health economics [ Time Frame: 5y ] [ Designated as safety issue: Yes ]
  • Vitamin/mineral deficiencies [ Time Frame: 5y ] [ Designated as safety issue: Yes ]
  • Body composition [ Time Frame: 5y ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 5y ] [ Designated as safety issue: Yes ]
  • Eating pattern [ Time Frame: 5y ] [ Designated as safety issue: Yes ]
  • Health economics
  • Vitamin/mineral deficiencies
  • Body composition
  • Quality of life
  • Eating pattern
Not Provided
Not Provided
 
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Diabetes
  • Hypertension
  • Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
  • Procedure: Laparoscopic Roux-en-Y Gastric Bypass
  • Experimental: 1
    Laparoscopic Biliopancreatic diversion with Duodenal switch
    Intervention: Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
  • Active Comparator: 2
    Laparoscopic Roux-en-Y Gastric Bypass
    Intervention: Procedure: Laparoscopic Roux-en-Y Gastric Bypass

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
NCT00327912
SU688-02
Not Provided
Göteborg University
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
Göteborg University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP