NCT00434655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

1.9 years

First QC Date

February 9, 2007

Last Update Submit

December 14, 2009

Conditions

Morbid Obesity

Keywords

Morbid obesityBariatric surgeryObesity surgeryGastric bandingSleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Short and long term clinical outcomes

    5 years

Secondary Outcomes (4)

  • Metabolic outcomes

    5 years

  • Esophago-gastric physiology

    2 years

  • Hormonal physiology

    5 years

  • Procedure costs

    5 years

Study Arms (2)

1 LAP BAND

ACTIVE COMPARATOR
Procedure: Laparoscopic restrictive procedure

2 Sleeve gastrectomy

EXPERIMENTAL
Procedure: Laparoscopic restrictive procedure

Interventions

Laparoscopic restrictive procedurePROCEDURE

Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.

1 LAP BAND2 Sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA North Texas

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esteban Varela, MD

    VA North Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

US(1)