Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity
NCT ID: NCT00327912
Last Updated: 2017-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2006-04-30
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Laparoscopic Biliopancreatic diversion with Duodenal switch
Laparoscopic Biliopancreatic diversion with Duodenal switch
2
Laparoscopic Roux-en-Y Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass
Interventions
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Laparoscopic Biliopancreatic diversion with Duodenal switch
Laparoscopic Roux-en-Y Gastric Bypass
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior major abdominal surgical procedure
* Severe disabling cardiopulmonary disease
* Malignancy
* Oral steroid treatment
* Condition associated with poor compliance
20 Years
50 Years
ALL
No
Sponsors
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Helse Sor-Ost
OTHER_GOV
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Hans H Lönroth, MD, PhD
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Tom Mala, MD, PhD
Role: STUDY_CHAIR
Aker University Hospital, Oslo, Norway
Jon Kristinsson, MD, PhD
Role: STUDY_CHAIR
Aker University Hospital, Oslo, Norway
Locations
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Dept of Surgery, Aker University Hospital
Oslo, Oslo County, Norway
Dept of Surgery, Sahlgrenska University Hospital
Gothenburg, Gothenburg, Sweden
Countries
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References
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Salte OBK, Olbers T, Risstad H, Fagerland MW, Sovik TT, Blom-Hogestol IK, Kristinsson JA, Engstrom M, Mala T. Ten-Year Outcomes Following Roux-en-Y Gastric Bypass vs Duodenal Switch for High Body Mass Index: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414340. doi: 10.1001/jamanetworkopen.2024.14340.
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.
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.
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.
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.
Other Identifiers
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SU688-02
Identifier Type: -
Identifier Source: org_study_id
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