Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes

• Weight Loss
• Co-morbid disease resolution

Inclusion Criteria:

Subjects must meet the following criteria to be eligible for study entry:

• Age between 18 - 80 years, and

• Severely or Morbidly obese:

  • BMI > 35, or
  • BMI > 30 + co-morbid obesity related disease condition

• Without any contraindications to bariatric surgery, and

• Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)

• Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain

Exclusion Criteria:

Subjects meeting the following criteria will be excluded from study entry:

• Any patient not meeting the inclusion criteria
• Patients with any major medical problems contraindicating surgery
• Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
• Patients who elect to undergo a surgery other than a PLAGB or SLAGB
• Pregnant or planning pregnancy within 12 months
• Alcohol or drug addiction
• Established infection anywhere in the body at the time of surgery
• Previous history of other bariatric surgery (except LAGB)
• Family or patient history of autoimmune disease