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Bariatric Outcomes Longitudinal Database (BOLD)
This study is currently recruiting participants.
Verified by Surgical Review Corporation, November 2009
First Received: October 26, 2009   Last Updated: November 2, 2009   History of Changes
Sponsor: Surgical Review Corporation
Information provided by: Surgical Review Corporation
ClinicalTrials.gov Identifier: NCT01002352
  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: Cohort, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 160000
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 have signed an approved informed consent document who 1) have bariatric surgery performed at an American Society for Bariatric Surgery designated Bariatric Surgery Center of Excellence, including centers which have Provisional Status designation, and 2) have bariatric surgery performed by a Fellow of the American Society for Bariatric Surgery, regardless of whether the surgery is performed at a designated Bariatric Surgery Center of Excellence. Patients under 18 years of age will be included if an informed consent document is signed by an authorized legal representative.

Informed consent will be obtained by the surgeon performing the surgery or a designee. The informed consent document and information pertaining to the BOLD study will be provided to the patient at the first pre-operative visit. The informed consent document must be signed by the surgeon or designee and the patient or the patient's authorized legal representative. The original signed informed consent document will be retained by the surgeon in a study file. A copy of the signed consent will be placed in the patient's medical record, and a copy of the signed consent will be provided to the patient.

Upon obtaining a signed informed consent document, the surgeon will collect initial data including date of consent, name, date of birth, height, weight, gender, race, ethnicity, and known comorbidities as of the date of the first pre-operative visit.

The following pre-operative data elements will be collected at the last visit prior to surgery. This information includes data collected at the first pre-operative visit which may have changed over time:

  • Weight
  • Comorbidities including diabetes, functional status, and various cardiovascular, metabolic, pulmonary, gastrointestinal, musculoskeletal, reproductive and psychosocial conditions
  • Medications
  • Prior bariatric and non-bariatric surgeries
  • History of smoking
  • Other conditions possibly affecting outcomes
  • Whether the planned procedure is a revision or reversal of a prior bariatric surgery

The following operative data elements will be collected:

  • Admit date
  • Date of surgery
  • Last weight before surgery
  • Operative time
  • Anesthesia time
  • Procedure performed
  • Surgical approach
  • Whether concurrent procedures were performed
  • DVT prophylaxis
  • Whether intra-operative fluids were received, and amounts
  • Anesthesia risk classification
  • Adverse pre-discharge events
  • Discharge date
  • Discharged to location

The following post-discharge data elements will be collected at each post-operative visit:

  • Weight
  • Rehospitalizations
  • Reoperations
  • Other events requiring intervention
  • Status of comorbidities
  • Status of medications

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002352

Contacts
Contact: Deborah Winegar, Ph.D. (919) 239-8194 debbie.winegar@surgicalreview.org

Locations
United States, North Carolina
Surgical Review Corporation Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Deborah Winegar, PH.D.     919-239-8194     debbie.winegar@surgicalreview.org    
Sponsors and Collaborators
Surgical Review Corporation
Investigators
Principal Investigator: Deborah Winegar, PH.D. Surgical Review Corporation
Principal Investigator: Eric J DeMaria, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Surgical Review Corporation ( D. Winegar, Ph.D. )
Study ID Numbers: BOLD
Study First Received: October 26, 2009
Last Updated: November 2, 2009
ClinicalTrials.gov Identifier: NCT01002352     History of Changes
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on February 09, 2010