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View Clinical Trial (Medical Research Study)

Bariatric Outcomes Longitudinal Database (BOLD) - NCT01002352-27609 (Clinical Trial 379258)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy379258.aspx



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City:  Raleigh
State:  
NC
Zip Code: 27609
Conditions: Obesity - Overweight - Diabetes
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.
Study summary: 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: 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
Study is available at: 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
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: ClinicalTrials.gov
Date Processed: November 17, 2009
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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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