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Bariatric Outcomes Longitudinal Database (BOLD) (BOLD)

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ClinicalTrials.gov Identifier: NCT01002352
Recruitment Status : Unknown
Verified November 2011 by Surgical Review Corporation.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Surgical Review Corporation

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.

Condition or disease
Obesity Overweight Diabetes

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.


Study Type : Observational
Estimated Enrollment : 600000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bariatric Outcomes Longitudinal Database (BOLD)
Study Start Date : June 2007
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017



Primary Outcome Measures :
  1. Improvement of comorbidities [ Time Frame: Within 1 year ]

Secondary Outcome Measures :
  1. Mortality, weight loss, surgical complications [ Time Frame: Within 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who qualify for bariatric surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002352


Locations
United States, North Carolina
Surgical Review Corporation
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Surgical Review Corporation
Investigators
Principal Investigator: Deborah Winegar, PH.D. Surgical Review Corporation

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Surgical Review Corporation
ClinicalTrials.gov Identifier: NCT01002352     History of Changes
Other Study ID Numbers: BOLD
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Surgical Review Corporation:
obesity
bariatric
BOLD
weightloss
database
data registry

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms