Adjustable Gastric Band Survey Study

NCT01041534 | Withdrawn DMC

• 3 other identifiers: 36720BA-08-01/Log 2FA7014-08-2-0002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to complete a survey study of patients who have undergone Adjustable Gastric Band (AGB) surgery at the University of Washington Medical Center (UWMC) and expanded to other bariatric surgical sites outside the University of Washington (UW), which will obtain a HIPAA waiver and a letter of cooperation) between April 1, 2007 and July 1, 2008. (Please note the University of Washington team will not have access to the site's list of patients, only access to coded returned surveys sent back from patients). Patients will be identified by obtaining operative case lists from the Department of Surgery Quality Improvement Team who maintain monthly records of bariatric procedures performed. We will obtain patient contact information (address) and patients will be contacted by mail with the request that they complete both the Adjustable Gastric Band (AGB) Health Survey and a standard Quality of Life survey (EQ5D). The mailing will include an Information Statement, the AGB Survey, the EQ5D, and a stamped return envelope. As an incentive, a $2 bill will be sent along with the first mailing to cover the costs of completing and returning the surveys. Patients who do not return survey within 30 days will be mailed a second survey. Patients who do not return the second survey within 30 days will be mailed a third survey. Patients who do not return the third survey will not be re-contacted.

Conditions

Morbid Obesity

Keywords

Adjustable gastric band, morbid obesity, bariatric surgery

Study Arms (1)

Adjustable Gastric Band (AGB) surgery

Patients who have undergone adjustable gastric band (AGB) surgery at the UWMC or other sites that have agreed to cooperate with our site (letter of cooperation and HIPAA waiver approved by our IRB) between April 1, 2007 and July 1, 2008.

Other: Survey

Interventions

Survey OTHER

Two surveys are sent to patients: Adjustable gastric band (AGB) Health Survey and a quality of life survey (EQ5D)

Adjustable Gastric Band (AGB) surgery

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

Patients who have undergone adjustable gastric band (AGB) surgery between April 1, 2007 and July 1, 2008 at University of Washington Medical Center (UWMC) or other sites that have been approved by our IRB (all within the Washington State area).

You may not qualify if:

• Current "Longitudinal Assessment of Bariatric Surgery (LABS)" study participation (note: LABS study captures similar information on utility and frequency of healthcare use, but has not yet published data that we could otherwise incorporate into our study. All LABS study sites, as University of Washington Medical Center (UWMC) is, are prohibited from duplicating research efforts in LABS enrolled patients to reduce burden on patients and conflict of interest in research reporting)

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98119, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David R Flum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Surgery

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 31, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2012
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (1)