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Completed

NCT Number: NCT00840736

LAGB Versus VBG: 7-Year Results

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.

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Key information

Conditions

Morbid Obesity Bariatric Surgery Body Weight Body Weight Changes Laparoscopic Adjustable Gastric Banding Long Term Results Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertical Banded Gastroplasty Weight Loss

Age range

19 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Laparoscopic Adjustable Gastric Banding

Procedure

Laparoscopic adjustable gastric banding

Other names: LAGB, AGB, LB, lap-band, SAGB

vertical banded gastroplasty

Procedure

vertical banded gastroplasty

Other names: VBG, Mason, gastroplasty

Primary outcomes

  1. weight loss

    Time frame: 84 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 10, 2009
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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