Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Jacksonville Surgical Associates
Sponsor:
Information provided by (Responsible Party):
Robert Cywes, M.D., PhD, Jacksonville Surgical Associates
ClinicalTrials.gov Identifier:
NCT01497028
First received: November 22, 2011
Last updated: December 21, 2011
Last verified: December 2011
  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 Jacksonville Surgical Associates:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 244
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Primary Completion Date: November 2011 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497028

Locations
United States, California
Ventura Advanced Surgical Associates Recruiting
Ventura, California, United States, 93003
Contact: Helmuth T Billy, M.D.    805-676-9100      
Principal Investigator: Helmuth T Billy, M.D.         
United States, Florida
Jacksonville Surgical Associates Recruiting
Jacksonville, Florida, United States, 32216
Contact: Robert Cywes, M.D., PhD    904-399-4004    robert@jaxchildren.com   
Contact: Melissa B Brown    904-399-4004 ext 104    melissab@jsapa.com   
Principal Investigator: Robert Cywes, M.D., PhD         
Sponsors and Collaborators
Jacksonville Surgical Associates
  More Information

No publications provided

Responsible Party: Robert Cywes, M.D., PhD, Prinicipal Investigator, Jacksonville Surgical Associates
ClinicalTrials.gov Identifier: NCT01497028     History of Changes
Other Study ID Numbers: PLAGB
Study First Received: November 22, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Jacksonville Surgical Associates:
Co-morbid disease resolution

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

ClinicalTrials.gov processed this record on July 22, 2014