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LAGB Versus VBG: 7-Year Results

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00840736
First received: February 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Morbid Obesity
Bariatric Surgery
Vertical Banded Gastroplasty
Laparoscopic Adjustable Gastric Banding
Long Term Results
 Procedure: Laparoscopic adjustable gastric banding
Procedure: vertical banded gastroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • weight loss [ Time Frame: 84 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • co-morbidity [ Time Frame: 84 months ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 84 months ] [ Designated as safety issue: No ]
  • reoperations / revisions / conversions [ Time Frame: 84 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 84 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Laparoscopic adjustable gastric banding
 Procedure: Laparoscopic adjustable gastric banding
Laparoscopic adjustable gastric banding
Other Name: LAGB, AGB, LB, lap-band, SAGB
Active Comparator: 2
vertical banded gastroplasty
 Procedure: vertical banded gastroplasty
vertical banded gastroplasty
Other Name: VBG, Mason, 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.

  Eligibility

Ages Eligible for Study:   19 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840736

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Jan Willem M Greve, Md PhD Atrium Medical Centre Parkstad
Principal Investigator: Ruben Schouten, MD Atrium Medical Centre Parkstad
  More Information

No publications provided

Responsible Party: Jan Willem M. Greve, MD PhD, Atrium Medical Centre Parkstad
ClinicalTrials.gov Identifier: NCT00840736     History of Changes
Other Study ID Numbers: LAGBvsVBG7y
Study First Received: February 9, 2009
Last Updated: February 9, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
VBG
LAGB
long term results
Weight loss
 Complications
Reoperations
Conversion

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2012