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

This study has been completed.

Sponsor:

Collaborator:

Alberta Health Services

Information provided by (Responsible Party):

Daniel Birch, University of Alberta

ClinicalTrials.gov Identifier:

NCT01149512

First received: June 21, 2010

Last updated: December 20, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 21, 2010
Last Updated Date	December 20, 2011
Start Date ^ICMJE	September 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01149512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
Official Title ^ICMJE	Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Morbid Obesity
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	250
Completion Date	September 2011
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01149512
Other Study ID Numbers ^ICMJE	Pro00014271
Has Data Monitoring Committee	No
Responsible Party	Daniel Birch, University of Alberta
Study Sponsor ^ICMJE	University of Alberta
Collaborators ^ICMJE	Alberta Health Services
Investigators ^ICMJE	Not Provided
Information Provided By	University of Alberta
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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