- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00840736
LAGB Versus VBG: 7-Year Results
February 9, 2009 updated by: Maastricht University Medical Center
Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One hundred morbidly obese patients were included in the study.
Randomization between the two operative techniques was performed using a computer model.
Fifty patients were included in both groups.
Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202 AZ
- Maastricht University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI of > 40 kg/m2 or > 35 kg/m2 with obesity-related comorbidities
- Failure to achieve sustainable weight loss with proven conservative measures
Exclusion Criteria:
- severe psychiatric and / or eating disorders
- unable to keep to a prescribed postoperative diet
- < 18 or > 60 years
- not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Laparoscopic adjustable gastric banding
|
Laparoscopic adjustable gastric banding
Other Names:
|
Active Comparator: 2
vertical banded gastroplasty
|
vertical banded gastroplasty
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight loss
Time Frame: 84 months
|
84 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
co-morbidity
Time Frame: 84 months
|
84 months
|
complications
Time Frame: 84 months
|
84 months
|
reoperations / revisions / conversions
Time Frame: 84 months
|
84 months
|
Quality of life
Time Frame: 84 months
|
84 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jan Willem M Greve, Md PhD, Atrium Medical Centre Parkstad
- Principal Investigator: Ruben Schouten, MD, Atrium Medical Centre Parkstad
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
February 9, 2009
First Submitted That Met QC Criteria
February 9, 2009
First Posted (Estimate)
February 10, 2009
Study Record Updates
Last Update Posted (Estimate)
February 10, 2009
Last Update Submitted That Met QC Criteria
February 9, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAGBvsVBG7y
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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