LAGB Versus VBG: 7-Year Results

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00840736
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : February 10, 2009
Information provided by:
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Bariatric Surgery Vertical Banded Gastroplasty Laparoscopic Adjustable Gastric Banding Long Term Results Procedure: Laparoscopic adjustable gastric banding Procedure: vertical banded gastroplasty Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
Study Start Date : May 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. weight loss [ Time Frame: 84 months ]

Secondary Outcome Measures :
  1. co-morbidity [ Time Frame: 84 months ]
  2. complications [ Time Frame: 84 months ]
  3. reoperations / revisions / conversions [ Time Frame: 84 months ]
  4. Quality of life [ Time Frame: 84 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00840736

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

Responsible Party: Jan Willem M. Greve, MD PhD, Atrium Medical Centre Parkstad Identifier: NCT00840736     History of Changes
Other Study ID Numbers: LAGBvsVBG7y
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by Maastricht University Medical Center:
long term results
Weight loss

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