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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Göteborg University

Additional 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
Study First Received: May 18, 2006
Last Updated: September 20, 2013
Health Authority: Sweden: The National Board of Health and Welfare
Norway: Norwegian Board of Health

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

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014