Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)
This study is currently recruiting participants.
Verified December 2011 by Jacksonville Surgical Associates
Sponsor:
Jacksonville Surgical Associates
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
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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
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 May 21, 2013