Bariatric Outcomes Longitudinal Database (BOLD)

Obesity Clinical Trial

— BOLD  

Official title:

Bariatric Outcomes Longitudinal Database (BOLD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01002352
• Other study ID #: BOLD
• Status: Active, not recruiting
• Phase: N/A
• First received: October 26, 2009
• Last updated: November 21, 2011
• Start date: June 2007
• Est. completion date: June 2017

Study information

• Verified date: November 2011
• Source: Surgical Review Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Overweight

Locations

Country	Name	City	State
United States	Surgical Review Corporation	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Surgical Review Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of comorbidities		Within 1 year	No
Secondary	Mortality, weight loss, surgical complications		Within 1 year	No

External Links

•   Surgical Review Corporation