Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

Veterans Affairs (VA) North Texas Health Care System

Status and phase: Completed; Phase 3

Conditions: Morbid Obesity

Treatments: Procedure: Laparoscopic restrictive procedure

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00434655

07-010

Details and patient eligibility

About

• 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.

Full description

This is a bariatric surgery Phase 3 prospective trial.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1 LAP BAND

Active Comparator group

Treatment:

Procedure: Laparoscopic restrictive procedure

2 Sleeve gastrectomy

Experimental group

Treatment:

Procedure: Laparoscopic restrictive procedure