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RALEIGH, NC — Surgical Review
Corporation (SRC), an independent, non-profit organization that
advances the safety, efficacy and efficiency of bariatric and metabolic
surgery, today announced results from the first analysis of data in its
Bariatric Outcomes Longitudinal Database™ (BOLD™), the
world’s largest dedicated repository of clinical bariatric
surgery patient information. The study validates the safety of
bariatric surgery performed by participants in the Bariatric Surgery
Centers of Excellence® (BSCOE®) program
and represents the first step toward identifying benchmarks for quality
and establishing guidelines for best clinical practices.
“Our results confirm the extraordinarily low risk associated with
bariatric surgery,” said Eric J. DeMaria, M.D., lead study
author, Chairman of SRC’s Research Advisory Committee and Vice
Chair of the Department of Surgery at Duke University Medical Center.
“When compared to national statistics, procedures performed by
BSCOEs are significantly safer than common operations like hip
replacement and gallbladder removal. BOLD provides the type and volume
of data necessary to effectively support these claims, which in turn
underscores the value of the BSCOE program.”
Dr. DeMaria presented the study at the American Society for Metabolic
and Bariatric Surgery (ASMBS) 26th Annual Meeting in Grapevine, Texas.
Results were based on clinical data from 57,918 research-consented
patients, representing the largest bariatric surgery patient population
ever analyzed:
- Procedure: The
most common bariatric procedure
was gastric bypass (54.8%), followed by gastric banding (39.8%), sleeve
gastrectomy (2.3%) and biliopancreatic diversion (0.9%).
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Complications:
Overall, 10.77% of patients
experienced one or more adverse events following surgery. Most
complications were considered relatively minor; nausea/vomiting was the
most frequently reported adverse event post-discharge.
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Mortality: The
total mortality rate across all
procedures was 0.135%, approximately one death per 1,000 patients.
Rates for 90- and 30-day all-cause mortality were 0.112% and 0.089%,
respectively.
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Age: A majority
of patients were between ages
19-65 (94.08%), while a minority were younger than 19 (0.14%) or older
than 65 (5.67%).
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Gender: Females
comprised a significant
majority of the study population (78.76%).
- Race: 78.12% of
patients were identified as
Caucasian, 10.52% African-American, 6.02% Hispanic, 0.2% Asian and
0.46% Native American.
“Our centers of excellence are truly living up to their
designation,” said Deborah A. Winegar, Ph.D., Director of
Research at SRC and a study co-author. “Through BOLD, the safety
of bariatric surgical procedures performed by BSCOEs can now be
substantiated with a meaningful, high quality data source.”
BOLD currently contains information on more than 130,000 bariatric
surgery patients. For this study, SRC analyzed prospective data entered
into BOLD between its launch in June 2007 and May 2009 by participants
in the ASMBS BSCOE program. Participants are required to enter
information into BOLD for all phases of bariatric surgical care,
including procedures, medications, demographic characteristics, weight
loss and maintenance, complications, and comorbidities. To ensure data
quality, SRC continuously verifies information entered into BOLD
through automated data checks and chart reviews conducted during site
inspections.
Unlike other research databases, information is entered into BOLD in
real-time, providing immediate analytical capabilities and a platform
for clinical studies. Users have immediate data access to guide
clinical decisions, and they can compare their own results against
national aggregate benchmark data to continuously strengthen care
delivery.
About Surgical Review
Corporation
Surgical Review Corporation (SRC) is an independent, non-profit
organization governed by industry stakeholders and dedicated to
advancing the safety, efficacy and efficiency of bariatric and
metabolic surgical care worldwide. To accelerate best practices
development for the treatment of morbid obesity and its associated
conditions, SRC launched center of excellence programs for bariatric
surgery and developed the Bariatric Outcomes Longitudinal Database
(BOLD). SRC has already designated nearly 650 surgeons as well as more
than 350 hospitals and freestanding outpatient facilities, and BOLD is
now the world’s largest repository of clinical bariatric surgery
patient data. For more information, visit surgicalreview.org.
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