Clinical trial NCT01002352: Bariatric Outcomes Longitudinal Database (BOLD)
Official title: Bariatric Outcomes Longitudinal Database (BOLD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Overweight
Diabetes
Keywords: obesity
bariatric
BOLD
weightloss
database
data registry
Lead sponsor: Surgical Review Corporation
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 600000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who qualify for bariatric surgery

Brief 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, peri-operative and post-operative care and treatment.

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.

Eligibility criteria: Inclusion Criteria:

* Bariatric surgery patients
* Males and Females
* All races

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement of comorbidities
timeFrame: Within 1 year
Secondary outcomes:
measure: Mortality, weight loss, surgical complications
timeFrame: Within 1 year
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Surgical Review Corporation
state: North Carolina
Study officials:
affiliation: Surgical Review Corporation
name: Deborah Winegar, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.