Back to resultsLAGB Versus VBG: 7-Year Results
Primary Purpose
Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Laparoscopic adjustable gastric banding
vertical banded gastroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring VBG, LAGB, long term results, Weight loss, Complications, Reoperations, Conversion
Eligibility Criteria
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)
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Laparoscopic adjustable gastric banding
vertical banded gastroplasty
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
co-morbidity
complications
reoperations / revisions / conversions
Quality of life
Full Information
NCT ID
NCT00840736
First Posted
February 9, 2009
Last Updated
February 9, 2009
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00840736
Brief Title
LAGB Versus VBG: 7-Year Results
Official Title
Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty, Laparoscopic Adjustable Gastric Banding, Long Term Results
Keywords
VBG, LAGB, long term results, Weight loss, Complications, Reoperations, Conversion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Laparoscopic adjustable gastric banding
Arm Title
2
Arm Type
Active Comparator
Arm Description
vertical banded gastroplasty
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic adjustable gastric banding
Other Intervention Name(s)
LAGB, AGB, LB, lap-band, SAGB
Intervention Description
Laparoscopic adjustable gastric banding
Intervention Type
Procedure
Intervention Name(s)
vertical banded gastroplasty
Other Intervention Name(s)
VBG, Mason, gastroplasty
Intervention Description
vertical banded gastroplasty
Primary Outcome Measure Information:
Title
weight loss
Time Frame
84 months
Secondary Outcome Measure Information:
Title
co-morbidity
Time Frame
84 months
Title
complications
Time Frame
84 months
Title
reoperations / revisions / conversions
Time Frame
84 months
Title
Quality of life
Time Frame
84 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Willem M Greve, Md PhD
Organizational Affiliation
Atrium Medical Centre Parkstad
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ruben Schouten, MD
Organizational Affiliation
Atrium Medical Centre Parkstad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
LAGB Versus VBG: 7-Year Results
We'll reach out to this number within 24 hrs