Laparoscopic Gastric Bypass Versus Sleeve Gastrectomy to Treat Morbid Obesity - Full Text View

Sponsored by:	Turku University Hospital
Information provided by:	Turku University Hospital
ClinicalTrials.gov Identifier:	NCT00793143

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

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Randomized Prospective Two-Center Study: Laparoscopic Gastric Bypass vs. Laparoscopic Sleeve Gastrectomy in the Treatment of Morbid Obesity

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:

Resolution of comorbidities [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Excessive weight loss [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 0 - 15 years ] [ Designated as safety issue: Yes ]
Morbidity [ Time Frame: 0 - 15 years ] [ Designated as safety issue: Yes ]
QOL (15D and BAROS) [ Time Frame: 3,6,12,18 months, 2,3,5,7,10,15 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Tissue samples

Enrollment:	160
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2025
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Sleeve
Bypass

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients rederred to two tertiary referral hospitals (Turku University Central Hospital and Vaasa Central Hospital)for treatmnet 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793143

Locations

Finland
Department of Surgery, Turku University Central Hospital
Turku, Finland, 20520
Vaasa Central Hospital
Vaasa, Finland

Sponsors and Collaborators

Turku University 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

More Information

Responsible Party:	Turku University Central Hospital, Department of surgery ( Paulina Salminen )
Study ID Numbers:	SLEE-PASS
Study First Received:	November 17, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793143
Health Authority:	Finland: Ethics Committee

Keywords provided by Turku University Hospital:

morbid obesity
laparoscopic sleeve gastrectomy
LSG
laparoscopic gastric bypass
LGB

comorbidities
diabetes
excessive weight loss
weight loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Diabetes Mellitus

Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 15, 2009