Clinical trial NCT00327912: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Diabetes
Hypertension
Keywords: Obesity
Surgery
Gastric bypass
Biliopancreatic diversion with Duodenal switch
Laparoscopy
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2006-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: BMI
timeFrame: 5 y
measure: Metabolic normalization
timeFrame: 5y
measure: Gastro-intestinal side effects
timeFrame: 5y
Secondary outcomes:
measure: Health economics
timeFrame: 5y
measure: Vitamin/mineral deficiencies
timeFrame: 5y
measure: Body composition
timeFrame: 5y
measure: Quality of life
timeFrame: 5y
measure: Eating pattern
timeFrame: 5y
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Surgery, Aker University Hospital
city: Gothenburg
country: Sweden
facility: Dept of Surgery, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Hans H Lönroth, MD, PhD
role: STUDY_CHAIR
affiliation: Aker University Hospital, Oslo, Norway
name: Tom Mala, MD, PhD
role: STUDY_CHAIR
affiliation: Aker University Hospital, Oslo, Norway
name: Jon Kristinsson, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.