ObesityBOLDNCT01002352
Bariatric Outcomes Longitudinal Database (BOLD)
An observational study of Obesity and Overweight, run by Surgical Review Corporation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Overweight, Diabetes
- How many people
- 600,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who qualify for bariatric surgery
Who may be able to join
- Bariatric surgery patients
- Males and Females
- All races
Who cannot join
- Negative psychological evaluation
- Surgeon's evaluation that patient is not a candidate for surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Surgical Review Corporation
Raleigh, North Carolina, 27609
About this study
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.
Read the 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.
- Conditions
- Obesity, Overweight, Diabetes
- Keywords
- obesity, bariatric, BOLD, weightloss, database, data registry
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of comorbidities
Measured: Within 1 year
Secondary outcomes (1)
Mortality, weight loss, surgical complications
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJun 2007
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surgical Review Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Winegar, PH.D., Principal investigator, Surgical Review Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002352
- Sponsor's protocol ID
- BOLD
- Acronym
- BOLD
- Status last verified
- Nov 2011
- First submitted
- 26 Oct 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Li W, Gorecki P, Semaan E, Briggs W, Tortolani AJ, D'Ayala M. Concurrent prophylactic placement of inferior vena cava filter in gastric bypass and adjustable banding operations in the Bariatric Outcomes Longitudinal Database. J Vasc Surg. 2012 Jun;55(6):1690-5. doi: 10.1016/j.jvs.2011.12.056. Epub 2012 Feb 22.
PubMed 22360915
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Outcomes Longitudinal Database (BOLD)
- ClinicalTrials.gov ID
- NCT01002352
- Acronym / sponsor ID
- BOLD / BOLD
- Conditions
- Obesity, Overweight, Diabetes
- Keywords
- obesity, bariatric, BOLD, weightloss, database, data registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600,000 participants (estimated)
- Lead sponsor
- Surgical Review CorporationUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who qualify for bariatric surgery
Key inclusion criteria (3 listed)
- Bariatric surgery patients
- Males and Females
- All races
Key exclusion criteria (2 listed)
- Negative psychological evaluation
- Surgeon's evaluation that patient is not a candidate for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement of comorbidities
Time frame: Within 1 year
1 secondary outcome
Mortality, weight loss, surgical complications
Time frame: Within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Derived from this study: PubMed 22360915Li W, Gorecki P, Semaan E, Briggs W, Tortolani AJ, D'Ayala M. Concurrent prophylactic placement of inferior vena cava filter in gastric bypass and adjustable banding operations in the Bariatric Outcomes Longitudinal Database. J Vasc Surg. 2012 Jun;55(6):1690-5. doi: 10.1016/j.jvs.2011.12.056. Epub 2012 Feb 22.
- Surgical Review CorporationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Winegar, PH.D. principal investigator
Surgical Review Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Surgical Review Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of comorbidities (time frame: Within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.