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| 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) |
| 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) |
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:
The following operative data elements will be collected:
The following post-discharge data elements will be collected at each post-operative visit:
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 |
All patients who qualify for bariatric surgery
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Deborah Winegar, Ph.D. | (919) 239-8194 | debbie.winegar@surgicalreview.org |
| 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 | |
| Principal Investigator: | Deborah Winegar, PH.D. | Surgical Review Corporation |
| Principal Investigator: | Eric J DeMaria, MD | Duke University |
More Information
| 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 |
|
obesity bariatric BOLD weightloss database |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |