Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600000 participants
OBSERVATIONAL
2007-06-30
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Males and Females
* All races
Exclusion Criteria
* Surgeon's evaluation that patient is not a candidate for surgery
ALL
No
Sponsors
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Surgical Review Corporation
OTHER
Responsible Party
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Principal Investigators
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Deborah Winegar, PH.D.
Role: PRINCIPAL_INVESTIGATOR
Surgical Review Corporation
Locations
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Surgical Review Corporation
Raleigh, North Carolina, United States
Countries
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References
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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.
Related Links
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Surgical Review Corporation
Other Identifiers
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BOLD
Identifier Type: -
Identifier Source: org_study_id