LAGB Versus VBG: 7-Year Results

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial

Conditions
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Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty, Laparoscopic Adjustable Gastric Banding, Long Term Results

Intervention / Treatment
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* Procedure: Laparoscopic adjustable gastric banding
* Procedure: vertical banded gastroplasty


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Laparoscopic adjustable gastric banding | Procedure: Laparoscopic adjustable gastric banding<br>* Laparoscopic adjustable gastric banding<br>* Other names: LAGB, AGB, LB, lap-band, SAGB;|
| Active Comparator: 2<br>vertical banded gastroplasty | Procedure: vertical banded gastroplasty<br>* vertical banded gastroplasty<br>* Other names: VBG, Mason, gastroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 84 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| co-morbidity |  | 84 months | 
| complications |  | 84 months | 
| reoperations / revisions / conversions |  | 84 months | 
| Quality of life |  | 84 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VBG, LAGB, long term results, Weight loss, Complications, Reoperations, Conversion