Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

NCT01497028 | Terminated DMC

• 1 other identifier: PLAGB
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Weight Loss

Keywords

Co-morbid disease resolution

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  3 years

Study Arms (2)

Plicated Gastric Banding

Procedure: 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.

Interventions

PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. PROCEDURE

PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.

Plicated Gastric Banding; Standard Gastric Banding

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jacksonville Surgical Associates: lead

Study Sites (2)

Ventura Advanced Surgical Associates

Ventura, California, 93003, United States

Location

Jacksonville Surgical Associates

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 22, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2011-12

Locations

US (2)