Plicated Laparoscopic Adjustable Gastric Banding Study

Phase 1UnknownNCT01944111

Tenet Healthcare Corporation100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Weight Loss

Interventions

PlicationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Des Peres Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: at least 1 year

Data from ClinicalTrials.gov

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