Bariatric Outcomes Longitudinal Database (BOLD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Surgical Review Corporation
ClinicalTrials.gov Identifier:
NCT01002352
First received: October 26, 2009
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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
Obesity
Overweight
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bariatric Outcomes Longitudinal Database (BOLD)

Resource links provided by NLM:


Further study details as provided by Surgical Review Corporation:

Primary Outcome Measures:
  • Improvement of comorbidities [ Time Frame: Within 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality, weight loss, surgical complications [ Time Frame: Within 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600000
Study Start Date: June 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by Surgical Review Corporation

Additional 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
Study First Received: October 26, 2009
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014