Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty, Laparoscopic Adjustable Gastric Banding, Long Term Results
Conditions
Keywords
VBG, LAGB, long term results, Weight loss, Complications, Reoperations, Conversion
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.
Interventions
Laparoscopic adjustable gastric banding
PROCEDUREvertical banded gastroplasty
vertical banded gastroplasty
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight loss | 84 months |
Secondary
| Measure | Time frame |
|---|---|
| co-morbidity | 84 months |
| complications | 84 months |
| reoperations / revisions / conversions | 84 months |
| Quality of life | 84 months |
Countries
Netherlands
Outcome results
None listed