Weight Loss
Conditions
Keywords
Gastric plication
Brief summary
Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.
Detailed 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.
Interventions
DEVICEPlication
Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.
Sponsors
Tenet Healthcare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | at least 1 year | Weight loss 4 weeks post surgical:20% additional than without plication, 3months post surgical: 30% additional than without plication, 6 months post surgical:30-40% additional than without plication, 1 year post surgical = 30-40% additional than without plication & at 1 year patient will require 50% fewer adjustments than without plication. |
Countries
United States
Outcome results
None listed