Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

August 9, 2017 updated by: Daniel Birch, University of Alberta
The majority of data documenting the outcomes for the adjustable gastric band (LAGB) originate from non-publicly funded surgical centres. The investigators aim to investigate the clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This program recognized obesity as a chronic disease, providing extensive pre-operative multidisciplinary assessment and long term patient follow-up. Patients are selected for surgical management carefully by a multidisciplinary team and the LAGB is presented as one option to surgical management. Further, the investigators will investigate the operational impacts, including direct and indirect costs related the LAGB, to determine long term impacts on publicly funded hospitals within Canada.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

178

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

    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Center for the Advancement of Minimally Invasive Surgery & Weight Wise Program

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

Sampling Method

Non-Probability Sample

Study Population

All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Description

Inclusion Criteria:

  • All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Exclusion criteria:

  • Patients who have undergone selection for surgery outside this process, or who have had surgery elsewhere.

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

Cohorts and Interventions

Group / Cohort
LAGB patients in Weight Wise Program
All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percentage Total Body Weight Loss
Time Frame: baseline to 1 year, baseline to 2 years, baseline to 3 years
the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years
baseline to 1 year, baseline to 2 years, baseline to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of Excess Body Weight Loss
Time Frame: baseline to 1 year, baseline to 2 years, baseline to 3 years
the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years
baseline to 1 year, baseline to 2 years, baseline to 3 years

Collaborators and Investigators

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

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

September 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00014271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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