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

January 12, 2016 updated by: Allison Barrett, Northwell Health

Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syosset, New York, United States, 11791
        • Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike
      • Syosset, New York, United States, 11791
        • Syosset Hospital, Center for Bariatric Surgical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index (BMI) > 35
  • Meet ASMBS and NIH criteria for Weight Loss Surgery
  • ASA Class I - III
  • Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
  • English speaking & comprehension
  • Normal mental caliber.

Exclusion Criteria:

  • Pregnancy, Liver failure or Kidney failure
  • Women of childbearing potential lactating at the time of initial consult or at the time of surgery
  • Any condition which precludes compliance with the study
  • History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAGB & LGCP

All study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB & LGCP).

The percent of Excess Body Weight Loss will be monitored at all post op visits.
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.
Other Names:
  • Laparoscopic Adjustable Gastric Band & Gastric Plication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Excess Body Weight Loss (%EWL)
Time Frame: 6 months post procedure
Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.
6 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HgbA1c
Time Frame: 12 months post procedure
A baseline HgbA1c will be obtained pre-operatively for study patients with a comorbid diagnosis of Type 2 Diabetes. HgbA1C will also be obtained at 6 months and 12 months to evaluate the change from the baseline HgbA1C.
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Study Chair: Robert Ward, MD, North Shore LIJ Health System, Syosset Hospital, Director of Surgery
  • Principal Investigator: Allison Barrett, MD, North Shore LIJ Health System Syosset Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

October 8, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-277A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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