We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497028
First Posted: December 22, 2011
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Cywes, M.D., PhD, Jacksonville Surgical Associates
  Purpose

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

Condition Intervention
Weight Loss Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Resource links provided by NLM:


Further study details as provided by Robert Cywes, M.D., PhD, Jacksonville Surgical Associates:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 3 years ]

Study Start Date: November 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497028


Locations
United States, California
Ventura Advanced Surgical Associates
Ventura, California, United States, 93003
United States, Florida
Jacksonville Surgical Associates
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Jacksonville Surgical Associates
  More Information

Responsible Party: Robert Cywes, M.D., PhD, Prinicipal Investigator, Jacksonville Surgical Associates
ClinicalTrials.gov Identifier: NCT01497028     History of Changes
Other Study ID Numbers: PLAGB
First Submitted: November 22, 2011
First Posted: December 22, 2011
Last Update Posted: April 3, 2015
Last Verified: December 2011

Keywords provided by Robert Cywes, M.D., PhD, Jacksonville Surgical Associates:
Co-morbid disease resolution

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms