- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149512
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
-
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Alberta
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Edmonton, Alberta, Canada, T5H 3V9
- Center for the Advancement of Minimally Invasive Surgery & Weight Wise Program
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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 |
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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