Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Weight Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Plicated Gastric Banding

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

Intervention Type PROCEDURE

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

Standard Gastric Banding

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

Intervention Type PROCEDURE

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

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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