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Laparoscopic Gastric Bypass Versus Sleeve Gastrectomy to Treat Morbid Obesity (SLEEVEPASS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793143
First Posted: November 19, 2008
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Vaasa Central Hospital, Vaasa, Finland
Helsinki University Central Hospital
Information provided by (Responsible Party):
Paulina Salminen, Turku University Hospital
  Purpose
Bariatric surgery in the treatment of morbid obesity is associated with long-term weight-loss and decreased overall mortality. Long-term results have been reported for laparoscopic gastric bypass procedures but the long-term results of laparoscopic sleeve gastrectomy are yet unavailable. As sleeve gastrectomy is a rapid and less traumatic procedure with good short-term results of weight loss and resolution of comorbidities, the investigators initiated a prospective randomized two-center study comparing laparoscopic sleeve gastrectomy (LSG)with laparoscopic gastric bypass (LGB) in the treatment of morbid obesity. Study hypothesis: As sleeve gastrectomy is less traumatic, easier and faster to perform compared with gastric bypass,LSG could become the procedure of choice to treat morbid obesity if the long-term results of weight loss and resolution of comorbidities are comparable with laparoscopic gastric bypass.

Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Prospective Three-center Study: Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity

Further study details as provided by Paulina Salminen, Turku University Hospital:

Primary Outcome Measures:
  • Excessive weight loss [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ]

Secondary Outcome Measures:
  • Resolution of comorbidities [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ]
  • Mortality [ Time Frame: 0 - 15 years ]
  • Morbidity [ Time Frame: 0 - 15 years ]
  • QOL (15D and BAROS) [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ]

Biospecimen Retention:   Samples With DNA
Tissue samples

Enrollment: 240
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sleeve
Bypass

Detailed Description:

In addition to comparing the outcomes between sleeve gastrectomy and gastric bypass, the study project includes a PET trial conducted in Turku. The objectives of this PET study are to measure effect of obesity on food-stimuli mediated brain activation response and on hormones affecting both feeding and energy balance. In the second part the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. In addition the effect of weight loss due to bariatric surgery on glucose uptake and free fatty acid metabolism is measured. The objective is also to study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the risk factors between these two surgical procedures. Regional glucose uptake and free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver and brain are studied with PET at baseline before bariatric surgery and post-operatively on the 3rd month. Changes in body fat distribution, in ectopic fat and fat content of key organs are investigated with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). Brain reward system response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter volumes using diffusion tensor imaging (DTI).

The study consists of 80 morbidly obese adults, BMI ≥ 40 kg/m2 or if there is additional risk factor BMI ≥ 35 kg/m2. From these subjects, 40 are further studied with positron emission tomography (PET) and magnetic resonance imaging (MRI). In addition functional MRI (fMRI) will be performed for 40 subjects. For fMRI, a control group is recruited consisting of 20 lean and healthy subjects. Subjects are physically examined and anthropometric data are measured along with blood sampling.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients rederred to three tertiary referral hospitals (Turku University Central Hospital, Vaasa Central Hospital and Peijas Hospital)for treatment of morbid obesity
Criteria

Inclusion Criteria:

  • BMI > 40 or BMI > 35 with a comorbidity associated with obesity
  • Age 18 - 60 years
  • Failed prior effective and controlled conservative treatments of morbid obesity

Exclusion Criteria:

  • BMI > 60
  • Difficult psychiatric conditions or lack of co-operation
  • Difficult eating disorder (binge eating, bulimia etc.)
  • Alcohol abuse
  • Gastric ulcer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793143


Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Department of Surgery, Turku University Central Hospital
Turku, Finland, 20520
Turku University Hospital, PET-center
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland
Sponsors and Collaborators
Turku University Hospital
Vaasa Central Hospital, Vaasa, Finland
Helsinki University Central Hospital
Investigators
Principal Investigator: Paulina Salminen, MD, PhD Turku Univeristy Central Hospital
Principal Investigator: Jari Ovaska, Md, PhD University of Turku
Principal Investigator: Mikael Victorzon, MD, PhD Vaasa Central Hospital, Vaasa, Finland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paulina Salminen, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00793143     History of Changes
Other Study ID Numbers: SLEEVEPASS
First Submitted: November 17, 2008
First Posted: November 19, 2008
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paulina Salminen, Turku University Hospital:
morbid obesity
laparoscopic sleeve gastrectomy
LSG
laparoscopic gastric bypass
LGB
comorbidities
diabetes
excessive weight loss
weight loss

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms