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: October 1, 2014
Last verified: October 2014
  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 2015
Estimated Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 1, 2014
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
Body Weight
Cardiovascular Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014