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Plicated Laparoscopic Adjustable Gastric Banding Study

Primary Purpose

Weight Loss

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Plication
Sponsored by
Tenet Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Gastric plication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Des Peres Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Plication

Arm Description

Prospective clinical trial comparing Standard Adustable Gastric Banding versus experimental Adjustable Gastric Banding

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2013
Last Updated
September 16, 2013
Sponsor
Tenet Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01944111
Brief Title
Plicated Laparoscopic Adjustable Gastric Banding Study
Official Title
Prospective Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tenet Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Gastric plication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plication
Arm Type
Experimental
Arm Description
Prospective clinical trial comparing Standard Adustable Gastric Banding versus experimental Adjustable Gastric Banding
Intervention Type
Device
Intervention Name(s)
Plication
Other Intervention Name(s)
Lap Band Plication, Adjustable gastric Banding with Plication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Scott, MD
Organizational Affiliation
Tenet Healthcare Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Des Peres Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States

12. IPD Sharing Statement

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Plicated Laparoscopic Adjustable Gastric Banding Study

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