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

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ClinicalTrials.gov Identifier: NCT00793143
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : August 24, 2017
Vaasa Central Hospital, Vaasa, Finland
Helsinki University Central Hospital
Information provided by (Responsible Party):
Paulina Salminen, Turku University Hospital

Brief Summary:
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 or disease
Morbid Obesity

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.

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Study Type : Observational
Actual Enrollment : 240 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010


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

Secondary Outcome Measures :
  1. Resolution of comorbidities [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ]
  2. Mortality [ Time Frame: 0 - 15 years ]
  3. Morbidity [ Time Frame: 0 - 15 years ]
  4. 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

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

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

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

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

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Responsible Party: Paulina Salminen, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00793143    
Other Study ID Numbers: SLEEVEPASS
First Posted: November 19, 2008    Key Record Dates
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
laparoscopic gastric bypass
excessive weight loss
weight loss
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight