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Morbid ObesityAGBNCT01041534

Adjustable Gastric Band Survey Study

An observational study of Morbid Obesity, run by University of Washington at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Morbid Obesity
What is being tested?
Survey
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2009to Sep 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • All patients that have undergone Adjustable gastric band (AGB bariatric surgery) and those with diagnoses of morbid obesity will be included. All patients having a AGB bariatric operation between April 1, 2007 and July 1, 2008 will be included in this analysis except for those with exclusionary diagnoses.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington

    Seattle, Washington, 98119

Other trials in United States

About this study

Official title: Data Investigation of Bariatric Surgery and Economic Savings: Adjustable Gastric Band (AGB) Survey Study

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.

Read the detailed description

While there has been considerable energy focused on the costs and effectiveness of bariatric surgery, there has been little systematically-gathered evidence on the non-surgical care and healthcare expenditures for similarly burdened patients. The economic burden and clinical impact of both need to be more carefully defined to help guide DOD decision making regarding obesity care. Understanding the cost effectiveness of obesity treatments is also critical given the cost of treatment procedures, their potential for saving future costs related to co-morbid health conditions and worker productivity and the growing population of operative candidates.

This study will provide a comprehensive assessment of the burden and costs of operative and non-operative obesity care across all regions in the U.S. where the Department of Defense (DOD) authorizes care. The development of economic assessment tools will allow health policy experts, purchasers and payers of healthcare, clinicians and patients to determine the utility and cost-effectiveness of available treatment strategies. These economic considerations are relevant to the competing crises of spiraling health care costs and the loss of productivity related to obesity.

The specific purpose of this study is to provide a comprehensive assessment of the burden and costs of operative and non-operative obesity care to develop a set of economic assessment tools that will allow health policy experts, purchasers and payers of healthcare, clinicians and patients to determine the utility and cost-effectiveness of available treatment strategies for managing obesity. Utility refers to qualitative components affected by clinical conditions such as individual's perceptions of quality of life, ability to take care of one-self, or ability to work/be productive. We anticipate that utility changes greatly for people who are able to achieve weight loss, but the differences or degree to which operative and non-operative weight loss treatments affects utility is not well known.

In particular, less is known about the effect of Adjustable Gastric Band (AGB) surgery on utility because it has only emerged as a predominant form of surgical treatment in the United States approximately within the last five years - for example, the first AGB surgery at UWMC was only performed in April 2007. In addition, assessment of cost-effectiveness of treatments requires understanding healthcare use after treatment (i.e. how many follow-up visits do you have with a doctor because of your surgical treatment) and AGB requires frequent follow-up visits in the first three years to make the surgical treatment effective. There is little information or research reporting the actual frequency of which patients are receiving follow-up care after AGB surgery, the cost for that care (is it a patient cost or insurance covered), or whether frequency of follow-up care affects long-term weight loss or health outcomes.

While the original procedures of our related study (IRB #35310, Committee E/A) only included secondary analysis of existing datasets, we have found very little information about qualitative utility or use/frequency of follow-up care for AGB patients and feel these are important aspects for modeling treatment choices for patients considering AGB. By adding a survey component, we will capture these data elements that are otherwise not found in literature or administrative datasets.

Conditions
Morbid Obesity
Being tested
Survey
Keywords
Adjustable gastric band, morbid obesity, bariatric surgery
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

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

Study groups in NCT01041534
Study groupRoleWhat they receive
Adjustable Gastric Band (AGB) surgeryPatients 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.
Receives: Other: Survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2011
  4. Study completionSep 2012

Why it stopped: This study did not enroll any participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041534
Sponsor's protocol ID
36720
Other IDs
BA-08-01/Log 2, FA7014-08-2-0002
Acronym
AGB
Status last verified
Dec 2022
First submitted
29 Dec 2009
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Morbid Obesity, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.

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