Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Jacksonville Surgical Associates

Status: Terminated

Conditions: Weight Loss

Treatments: Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

Study type: Observational

Funder types: Other

Identifiers

NCT01497028

PLAGB

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Plicated Gastric Banding

Treatment:

Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

Standard Gastric Banding

Treatment:

Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.