LAGB Versus VBG: 7-Year Results

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840736
• Other study ID #: LAGBvsVBG7y
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: February 9, 2009
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 59 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery
• Laparoscopic Adjustable Gastric Banding
• Long Term Results
• Morbid Obesity
• Obesity, Morbid
• Vertical Banded Gastroplasty

Intervention

Procedure:
• Laparoscopic adjustable gastric banding
Laparoscopic adjustable gastric banding
• vertical banded gastroplasty
vertical banded gastroplasty

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		84 months	No
Secondary	co-morbidity		84 months	No
Secondary	complications		84 months	No
Secondary	reoperations / revisions / conversions		84 months	No
Secondary	Quality of life		84 months	No