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LAGB Versus VBG: 7-Year Results

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

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Jan Willem M. Greve, MD PhD, Atrium Medical Centre Parkstad Identifier: NCT00840736     History of Changes
Other Study ID Numbers: LAGBvsVBG7y
Study First Received: February 9, 2009
Last Updated: February 9, 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 processed this record on July 25, 2017