Plicated Laparoscopic Adjustable Gastric Banding Study

Phase 1

• Conditions: Weight Loss
• Interventions: Device: Plication

• Registration Number: NCT01944111
• Lead Sponsor: Tenet Healthcare Corporation

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.

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plication	Plication	Prospective clinical trial comparing Standard Adustable Gastric Banding versus experimental Adjustable Gastric Banding

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Des Peres Hospital; 🇺🇸 St. Louis, Missouri, United States