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

Primary Purpose

Obesity, Diabetes, Hypertension

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Laparoscopic Biliopancreatic diversion with Duodenal switch
Laparoscopic Roux-en-Y Gastric Bypass
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Surgery, Gastric bypass, Biliopancreatic diversion with Duodenal switch, Laparoscopy

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Surgery, Aker University Hospital
  • Dept of Surgery, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Laparoscopic Biliopancreatic diversion with Duodenal switch

Laparoscopic Roux-en-Y Gastric Bypass

Outcomes

Primary Outcome Measures

BMI
Metabolic normalization
Gastro-intestinal side effects

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2006
Last Updated
February 1, 2017
Sponsor
Göteborg University
Collaborators
Helse Sor-Ost
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1. Study Identification

Unique Protocol Identification Number
NCT00327912
Brief Title
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity
Acronym
ASGARD
Official Title
Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Helse Sor-Ost

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Hypertension
Keywords
Obesity, Surgery, Gastric bypass, Biliopancreatic diversion with Duodenal switch, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Laparoscopic Biliopancreatic diversion with Duodenal switch
Arm Title
2
Arm Type
Active Comparator
Arm Description
Laparoscopic Roux-en-Y Gastric Bypass
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Biliopancreatic diversion with Duodenal switch
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Roux-en-Y Gastric Bypass
Primary Outcome Measure Information:
Title
BMI
Time Frame
5 y
Title
Metabolic normalization
Time Frame
5y
Title
Gastro-intestinal side effects
Time Frame
5y
Secondary Outcome Measure Information:
Title
Health economics
Time Frame
5y
Title
Vitamin/mineral deficiencies
Time Frame
5y
Title
Body composition
Time Frame
5y
Title
Quality of life
Time Frame
5y
Title
Eating pattern
Time Frame
5y

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans H Lönroth, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tom Mala, MD, PhD
Organizational Affiliation
Aker University Hospital, Oslo, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jon Kristinsson, MD, PhD
Organizational Affiliation
Aker University Hospital, Oslo, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Surgery, Aker University Hospital
City
Oslo
Country
Norway
Facility Name
Dept of Surgery, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25650964
Citation
Risstad H, Sovik TT, Engstrom M, Aasheim ET, Fagerland MW, Olsen MF, Kristinsson JA, le Roux CW, Bohmer T, Birkeland KI, Mala T, Olbers T. Five-year outcomes after laparoscopic gastric bypass and laparoscopic duodenal switch in patients with body mass index of 50 to 60: a randomized clinical trial. JAMA Surg. 2015 Apr;150(4):352-61. doi: 10.1001/jamasurg.2014.3579.
Results Reference
derived
PubMed Identifier
21893621
Citation
Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005.
Results Reference
derived
PubMed Identifier
20035530
Citation
Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, Schou CF, Lonroth H, Mala T, Olbers T. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg. 2010 Feb;97(2):160-6. doi: 10.1002/bjs.6802.
Results Reference
derived
PubMed Identifier
19439456
Citation
Aasheim ET, Bjorkman S, Sovik TT, Engstrom M, Hanvold SE, Mala T, Olbers T, Bohmer T. Vitamin status after bariatric surgery: a randomized study of gastric bypass and duodenal switch. Am J Clin Nutr. 2009 Jul;90(1):15-22. doi: 10.3945/ajcn.2009.27583. Epub 2009 May 13. Erratum In: Am J Clin Nutr. 2010 Jan;91(1):239-40.
Results Reference
derived

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

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