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ObesityBOLDNCT01002352

Bariatric Outcomes Longitudinal Database (BOLD)

An observational study of Obesity and Overweight, run by Surgical Review Corporation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to assess the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative… Read more about this study

Who is it for?
Any age
Conditions the study is for
Obesity, Overweight, Diabetes
How many people
600,000 participants
Where
1 siteUnited States
Study dates
Jun 2007to Jun 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who qualify for bariatric surgery

Who may be able to join

  • Bariatric surgery patients
  • Males and Females
  • All races

Who cannot join

  • Negative psychological evaluation
  • Surgeon's evaluation that patient is not a candidate for surgery

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Surgical Review Corporation

    Raleigh, North Carolina, 27609

Other trials in United States

About this study

The primary purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to assess the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative and post-operative care and treatment.

Read the detailed description

Participants in the BOLD study include all patients who 1) have their bariatric surgery performed by either a Participant in the American Society for Metabolic and Bariatric Surgery designated Bariatric Surgery Center of Excellence or by a Fellow of the American Society for Metabolic and Bariatric Surgery 2) have been provided with a copy of the BOLD Patient Information Sheet. Patients under 18 years of age are included if a copy of the Patient Information Sheet is provided to an authorized legal representative.

The Patient Information Sheet containing information pertaining to the BOLD study is provided to the patient at the first pre-operative visit. The patient is not required to sign a consent form to participate in the study but must let the bariatric surgeon staff know if he/she does not wish to participate.

The following information will be collected for every bariatric surgery patient:

  • Personal information: gender, race, employment status, insurance status, medical record number, year of birth, height, weight and prior surgeries. The surgeon has the option of entering patient name for internal tracking purposes.
  • Information about surgery: date of admission, date of surgery and date of discharge.
  • Information about medical condition before, during and after surgery.

Patient information is entered into BOLD through a secure website and permanently stored in a database that is managed by Surgical Review Corporation (SRC). This database is secure and meets the requirements for the protection of patient confidentiality as required by the Health Insurance Portability and Accountability Act (HIPAA).

Data that is used for research does not include the patient name or medical record number. Information about the patient's surgery will be combined with data from all other study participants in a separate research database and SRC research staff will analyze this combined information. The results of the study will be reported or published for the total population - no individual patient information will be published.

Surgeons participating in the study will attempt to obtain follow-up data on all patients who had surgery once a year for a minimum of at least five years following the date of surgery. Follow-up data can be obtained by the operating surgeon or designee, or by the patient's primary care physician and reported to the surgeon.

Keywords
obesity, bariatric, BOLD, weightloss, database, data registry
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Weight Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of comorbidities

    Measured: Within 1 year

Secondary outcomes (1)
  1. Mortality, weight loss, surgical complications

    Measured: Within 1 year

Timeline

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

  1. First posted27 Oct 2009 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

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
600,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01002352
Sponsor's protocol ID
BOLD
Acronym
BOLD
Status last verified
Nov 2011
First submitted
26 Oct 2009
Last updated
22 Nov 2011
Results posted
No
Data monitoring committee
No

Publications

  • Li W, Gorecki P, Semaan E, Briggs W, Tortolani AJ, D'Ayala M. Concurrent prophylactic placement of inferior vena cava filter in gastric bypass and adjustable banding operations in the Bariatric Outcomes Longitudinal Database. J Vasc Surg. 2012 Jun;55(6):1690-5. doi: 10.1016/j.jvs.2011.12.056. Epub 2012 Feb 22.

    PubMed 22360915

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Overweight, run by Surgical Review Corporation 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2011. 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?

Results are not available in the source record.

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.

What does the primary outcome measure?

Improvement of comorbidities (time frame: Within 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01002352, which also lists 1 linked publication.

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 22 Nov 2011.

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