Laparoscopic Adjustable Gastric Banding Versus Laparoscop... | NCT00434655

Studies
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

NCT00434655

Sponsor

North Texas Veterans Healthcare System

Status

Completed

Last Update Posted

Dec 15, 2009Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Morbid Obesity

Interventions

Laparoscopic restrictive procedure

Countries

United States

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

Dec 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

Jan 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 9, 2007

First Submission Date that Met QC Criteria

Feb 9, 2007

First Posted Date

Feb 13, 2007Estimated

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

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Description Module

Brief Summary

The investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with comorbidities or BMI > 40) in VETERANS.
The investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.

Detailed Description

This is a bariatric surgery Phase 3 prospective trial.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 LAP BAND	Active Comparator		Procedure: Laparoscopic restrictive procedure
2 Sleeve gastrectomy	Experimental		Procedure: Laparoscopic restrictive procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic restrictive procedure	Procedure	Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.	1 LAP BAND 2 Sleeve gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Short and long term clinical outcomes		5 years

Secondary Outcomes

Measure	Description	Time Frame
Metabolic outcomes		5 years
Esophago-gastric physiology		2 years
Hormonal physiology

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI > 40)
Age > 18 y/o

Exclusion Criteria:

Pregnancy
Severe uncontrolled medical or psychiatric conditions
Previous bariatric surgery
Multiple previous abdominal surgeries

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Esteban Varela, MD	VA North Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA North Texas		Dallas	Texas	75216	United States

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided