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View Clinical Trial (Medical Research Study)
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Bariatric Outcomes Longitudinal Database (BOLD) - NCT01002352-27609 (Clinical Trial 379258)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy379258.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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Raleigh |
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State:
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NC |
| Zip Code: |
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27609 |
| Conditions: |
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Obesity - Overweight - Diabetes |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Surgical Review Corporation
Raleigh, NC 27609
United States
Primary Contact:
Deborah Winegar, PH.D.
Email: debbie.winegar@surgicalreview.org
Phone: 919-239-8194
Secondary Contact:
Deborah Winegar, Ph.D.
Email: debbie.winegar@surgicalreview.org
Phone: (919) 239-8194 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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