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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:


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
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 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, Morbid
Body Weight
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014