LAGB Versus VBG: 7-Year Results | NCT00840736

Studies
LAGB Versus VBG: 7-Year Results

NCT00840736

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 10, 2009Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

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

Interventions

Laparoscopic adjustable gastric banding
vertical banded gastroplasty

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Feb 9, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2009

Last Update Posted Date

Feb 10, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Laparoscopic adjustable gastric banding	Procedure: Laparoscopic adjustable gastric banding
2	Active Comparator	vertical banded gastroplasty	Procedure: vertical banded gastroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic adjustable gastric banding	Procedure	Laparoscopic adjustable gastric banding	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss		84 months

Secondary Outcomes

Measure	Description	Time Frame
co-morbidity		84 months
complications		84 months
reoperations / revisions / conversions

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Willem M Greve, Md PhD	Atrium Medical Centre Parkstad	Study Director
Ruben Schouten, MD	Atrium Medical Centre Parkstad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre		Maastricht	Limburg	6202 AZ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D015431	Weight Loss

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015391	Gastroplasty

Ancestor Terms

ID	Term
D050110	Bariatric Surgery
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided