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Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00434655
Enrollment
40
Registered
2007-02-13
Start date
2008-01-31
Completion date
2009-12-31
Last updated
2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Morbid obesity, Bariatric surgery, Obesity surgery, Gastric banding, Sleeve gastrectomy

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.

Interventions

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

Sponsors

North Texas Veterans Healthcare System
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Short and long term clinical outcomes5 years

Secondary

MeasureTime frame
Metabolic outcomes5 years
Esophago-gastric physiology2 years
Hormonal physiology5 years
Procedure costs5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026