LAGB Versus VBG: 7-Year Results

NCT ID: NCT00840736

Last Updated: 2009-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-07-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Laparoscopic adjustable gastric banding

Group Type ACTIVE_COMPARATOR

Laparoscopic adjustable gastric banding

Intervention Type PROCEDURE

Laparoscopic adjustable gastric banding

2

vertical banded gastroplasty

Group Type ACTIVE_COMPARATOR

vertical banded gastroplasty

Intervention Type PROCEDURE

vertical banded gastroplasty

Interventions

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Laparoscopic adjustable gastric banding

Laparoscopic adjustable gastric banding

Intervention Type PROCEDURE

vertical banded gastroplasty

vertical banded gastroplasty

Intervention Type PROCEDURE

Other Intervention Names

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LAGB, AGB, LB, lap-band, SAGB VBG, Mason, gastroplasty

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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Atrium Medical Centre Parkstad

Principal Investigators

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Jan Willem M Greve, Md PhD

Role: STUDY_DIRECTOR

Atrium Medical Centre Parkstad

Ruben Schouten, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Medical Centre Parkstad

Locations

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Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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LAGBvsVBG7y

Identifier Type: -

Identifier Source: org_study_id

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