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Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

NCT01564732 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-07-01

Study results available
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Summary

The purpose of this study is to compare plicated laparoscopic adjustable gastric banding (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective randomized clinical trial. We hypothesize the plicated procedure will provide greater short- and long-term excess weight loss than the standard procedure. There exists little prospective randomized data regarding this topic and the recent position statement from the American Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further information on background and design of this study are provided in the detailed description.

Conditions

  • Morbid Obesity

Interventions

DEVICE

Standard-LAGB

The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

DEVICE

Plicated-LAGB

At the time of LAGB placement, plication sutures can be placed along the body \& greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Dana Portenier, MD

    lead OTHER

Principal Investigators

  • Dana D Portenier, MD · Duke University

  • Carol McCloskey, MD · University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564732 on ClinicalTrials.gov