Plicated Laparoscopic Adjustable Gastric Banding Study

Study Overview
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Brief Summary
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Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

Detailed Description
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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.

Official Title
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Prospective Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Conditions
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Weight Loss

Intervention / Treatment
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* Device: Plication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plication<br>Prospective clinical trial comparing Standard Adustable Gastric Banding versus experimental Adjustable Gastric Banding | Device: Plication<br>* 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.<br>* Other names: Adjustable gastric Banding with Plication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | 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. | at least 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric plication