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LAGB Versus VBG: 7-Year Results

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840736
First Posted: February 10, 2009
Last Update Posted: February 10, 2009
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.
Information provided by:
Maastricht University Medical Center
  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
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

Further study details as provided by Maastricht University Medical Center:

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

Secondary Outcome Measures:
  • co-morbidity [ Time Frame: 84 months ]
  • complications [ Time Frame: 84 months ]
  • reoperations / revisions / conversions [ Time Frame: 84 months ]
  • Quality of life [ Time Frame: 84 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jan Willem M. Greve, MD PhD, Atrium Medical Centre Parkstad
ClinicalTrials.gov Identifier: NCT00840736     History of Changes
Other Study ID Numbers: LAGBvsVBG7y
First Submitted: February 9, 2009
First Posted: February 10, 2009
Last Update Posted: February 10, 2009
Last Verified: February 2009

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

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


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