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: February 1, 2017

Last verified: February 2017

History of Changes

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 Intervention Model: Parallel Assignment Masking: No masking 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

Further study details as provided by Göteborg University:

Primary Outcome Measures:

BMI [ Time Frame: 5 y ]
Metabolic normalization [ Time Frame: 5y ]
Gastro-intestinal side effects [ Time Frame: 5y ]

Secondary Outcome Measures:

Health economics [ Time Frame: 5y ]
Vitamin/mineral deficiencies [ Time Frame: 5y ]
Body composition [ Time Frame: 5y ]
Quality of life [ Time Frame: 5y ]
Eating pattern [ Time Frame: 5y ]


Estimated Enrollment:	60
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (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 (Adult)
Sexes Eligible for Study:	All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Risstad H, Søvik TT, Engström M, Aasheim ET, Fagerland MW, Olsén MF, Kristinsson JA, le Roux CW, Bøhmer 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.

Søvik TT, Aasheim ET, Taha O, Engström M, Fagerland MW, Björkman 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.

Søvik TT, Taha O, Aasheim ET, Engström M, Kristinsson J, Björkman S, Schou CF, Lönroth 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.

Aasheim ET, Björkman S, Søvik TT, Engström M, Hanvold SE, Mala T, Olbers T, Bøhmer 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.


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:	February 1, 2017

Keywords provided by Göteborg University:


Obesity Surgery Gastric bypass Biliopancreatic diversion with Duodenal switch Laparoscopy

ClinicalTrials.gov processed this record on July 17, 2017

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