Plicated Laparoscopic Adjustable Gastric Banding Study

Tenet Healthcare

Status and phase

Unknown

Phase 1

Conditions

Weight Loss

Treatments

Device: Plication

Study type

Interventional

Funder types

Other

Identifiers

NCT01944111

2315-1

Details and patient eligibility

About

Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

Full description

This is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. All enrolled patients will choose to either standard (control group) banding or plication (study group) banding. Each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and Green Zone Patient Questionnaire at each visit.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age older than 18 years
Morbidly Obese
BMI >40 or
BMI >35 plus co-morbid obesity related disease conditions
Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease
Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi

Exclusion criteria

Any patient not meeting the inclusion criteria
Patients with any major medical problems contraindicating surgery
Patients with a medically treatable cause of obesity
Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding
Alcohol or drug addiction
Established infection anywhere in the body at the time of surgery
Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis
Family or patient history of autoimmune disease