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Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

NCT01703546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2016-01-14

No results posted yet for this study

Summary

The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

Conditions

  • Morbid Obesity

Interventions

PROCEDURE

LAGB & LGCP

All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band \& Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Robert Ward, MD · North Shore LIJ Health System, Syosset Hospital, Director of Surgery

  • Allison Barrett, MD · North Shore LIJ Health System Syosset Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT01703546 on ClinicalTrials.gov