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

NCT01149512 | Completed Results

• 1 other identifier: Pro00014271
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Total Body Weight Loss

  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 Outcomes (1)

• % of Excess Body Weight Loss

  baseline to 1 year, baseline to 2 years, baseline to 3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Center for the Advancement of Minimally Invasive Surgery & Weight Wise Program

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Xinzhe Shi
• Organization: Royal Alexandra Hospital

xinzhe.shi@ahs.ca

7807356735

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, MD, FRCSC, FACS

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: September 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 11, 2017
• Results First Posted: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)