Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

April 2, 2015 updated by: Robert Cywes, M.D., PhD, Jacksonville Surgical Associates

Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes

  • Weight Loss
  • Co-morbid disease resolution

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Ventura Advanced Surgical Associates
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Surgical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients between the ages of 18-80 years of age who are severly or morbidly obese and meet NIH and FDA criteria for baratric surgery (BMI>30+ co-morbid disease or BMI>35) who are undergoing baratric surgery at Jacksonville Surgical Associates, P.A. or Ventura Advanced Surgical Associates will be returned. All enrolled patients will be assigned to either the SLAGB (control)group or the PLAGB (study) group.

Description

Inclusion Criteria:

Subjects must meet the following criteria to be eligible for study entry:

  • Age between 18 - 80 years, and

  • Severely or Morbidly obese:

    • BMI > 35, or
    • BMI > 30 + co-morbid obesity related disease condition
  • Without any contraindications to bariatric surgery, and
  • Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
  • Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain

Exclusion Criteria:

Subjects meeting the following criteria will be excluded from study entry:

  • Any patient not meeting the inclusion criteria
  • Patients with any major medical problems contraindicating surgery
  • Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
  • Patients who elect to undergo a surgery other than a PLAGB or SLAGB
  • Pregnant or planning pregnancy within 12 months
  • Alcohol or drug addiction
  • Established infection anywhere in the body at the time of surgery
  • Previous history of other bariatric surgery (except LAGB)
  • Family or patient history of autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Plicated Gastric Banding
Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
Standard Gastric Banding
Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacksonville Surgical Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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