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: August 29, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 18, 2006

Last Updated Date

August 29, 2012

Start Date ^ICMJE

April 2006

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

BMI
Metabolic normalization
Gastro-intestinal side effects

Change History

Complete list of historical versions of study NCT00327912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Health economics
Vitamin/mineral deficiencies
Body composition
Quality of life
Eating pattern

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial

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).

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Obesity
Diabetes
Hypertension

Intervention ^ICMJE

Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
Procedure: Laparoscopic Roux-en-Y Gastric Bypass

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00327912

Other Study ID Numbers ^ICMJE

SU688-02

Has Data Monitoring Committee

Not Provided

Responsible Party

Göteborg University

Study Sponsor ^ICMJE

Göteborg University

Collaborators ^ICMJE

Helse Sor-Ost

Investigators ^ICMJE

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

Information Provided By

Göteborg University

Verification Date

August 2012

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

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