Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Terminated

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

• Registration Number: NCT01497028
• Lead Sponsor: Jacksonville Surgical Associates

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-22
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Plicated Gastric Banding	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.	-

Primary Outcome Measures

Name	Time	Method
Weight Loss	3 years

Trial Locations

Locations (2)

Ventura Advanced Surgical Associates; 🇺🇸 Ventura, California, United States

Jacksonville Surgical Associates; 🇺🇸 Jacksonville, Florida, United States