study presented at SAGES 2011
NORTH HAVEN, Conn., Apr 05, 2011 (BUSINESS WIRE) —
Covidien (NYSE: COV), a leading global provider of healthcare
products, today announced interim results of its multicenter,
international, prospective SILS(TM) Port laparoscopic
cholecystectomy (removal of the gall bladder) post-market clinical
study.
“The interim results of this study show that single-incision
gall bladder surgery appears to be as safe and effective as
standard multi-port cholecystectomy. In addition, patients may view
the cosmetic results as superior when compared to the traditional
four-port laparoscopic approach,” said primary investigator Jeffrey
M. Marks, M.D., FACS. “This prospective study is designed to
confirm that a single-incision procedure is safe and to determine
whether the perceived benefits will hold true across a wider
population of patients. If the final results remain in line with
this interim analysis, I expect a growing number of patients
concerned about the appearance of their abdomens to seek out
surgeons who offer them the choice of a major operation with fewer
incisions.”
Dr. Marks is Associate Professor in the Department of Surgery
and Director of Surgical Endoscopy at University Hospitals at Case
Medical Center in Cleveland, OH. His team presented the interim
topline results of the study during a podium presentation at SAGES
2011, the annual meeting of the Society of American
Gastrointestinal and Endoscopic Surgeons, which took place in San
Antonio, TX from March 30 to April 2.
The prospective, randomized, controlled trial was designed to
assess the feasibility and safety of performing gall bladder
surgery via a single incision through the belly button with the aid
of Covidien’s SILS Port. The study protocol allows participating
surgeons to objectively document the scientific merit and the
perceived advantages using the SILS Port through a single incision
over a traditional laparoscopic technique (four incisions). The
participating surgeons will monitor patients in the study for a
year after the procedure to track their pain, quality of life and
the cosmetic appearance of their abdomens.
All 200 patients have now been enrolled in the study; this data
analysis includes preliminary results of 189 patients.
The 111 patients who underwent gall bladder surgery with the
single incision approach reported significantly better cosmetic
outcomes up to three months after their procedures, compared to the
group whose surgeons used four laparoscopic ports. The pain scores
between the two groups were within one point of each other on a 10
point visual analog scale rendering pain as clinically similar
between the two groups. Surgeons, on average, took 12 minutes
longer to perform the gall bladder surgery with the single-port
approach (57 vs. 45 min., p<0.0001), but there was no difference
in blood loss during the operation.
“Covidien is dedicated to collaborating with the surgical
community to generate evidence that supports the use of its
innovative products to help patients achieve better outcomes,” said
Michael Tarnoff, M.D., Chief Medical Officer, Covidien. “This is
one of the largest prospective studies of the SILS technique
conducted to date in the U.S. Covidien’s surgical devices business
is firmly committed to bring products like the SILS Port to market
that aim to reduce the surgical footprint.”
Covidien’s SILS Port is an advanced surgical product designed to
allow laparoscopic surgery through a single incision. This product
is designed to give surgeons the ability to use multiple
instruments with maximal maneuverability through a single incision
in the patient’s umbilicus (belly button). The SILS Port leaves a
hidden scar when used in the umbilicus and may minimize
postoperative pain when compared to traditional open
procedures.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that
creates innovative medical solutions for better patient outcomes
and delivers value through clinical leadership and excellence.
Covidien manufactures, distributes and services a diverse range of
industry-leading product lines in three segments: Medical Devices,
Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4
billion, Covidien has approximately 42,000 employees worldwide in
more than 65 countries, and its products are sold in over 140
countries. Please visit
www.covidien.com to learn more about our business.
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