New Studies Demonstrate Benefits of Minimally Invasive Hysterectomy and Colectomy When Compared to Open Surgery

New Studies Demonstrate Benefits of Minimally Invasive Hysterectomy and
Colectomy When Compared to Open Surgery
Significant Clinical and Economic Benefits Found in Analysis of More than
25,000 Procedures

CINCINNATI, Oct. 26 /PRNewswire/ -- Ethicon Endo-Surgery today announced
results from two newly published studies that demonstrate a minimally invasive
approach in three common procedures resulted in a reduced rate of
complications and lower overall cost of care, including a difference of more
than $15,000 on average for minimally invasive colectomies, when compared to
open surgery. One study compared two types of minimally invasive hysterectomy
procedures to open abdominal hysterectomy(i) and another study analyzed
outcomes of minimally invasive approaches for appendectomy and colectomy
procedures compared to open surgery(ii).

The study titled "Open Abdominal versus Laparoscopic and Vaginal Hysterectomy:
Analysis of a Large United States Payer Measuring Quality and Cost of Care"
showed, in line with previous studies, minimally invasive hysterectomy reduced
rates of postoperative infection and length of stay in the hospital when
compared to open abdominal hysterectomy. Open surgery was also associated with
higher costs than those who underwent laparoscopic and vaginal hysterectomy.
Given these findings, the study authors concluded a substantial opportunity
exists to shift more hysterectomies from an in-patient to an outpatient
setting while maintaining or improving the clinical outcome for patients.

"The clinical and economic outcomes of the study demonstrate the need for
higher adoption of minimally invasive hysterectomy procedures in patients who
are candidates for this approach," said Lori Warren, M.D.,* lead author of the
study and an advanced gynecologic laparoscopic surgeon with Women First of
Louisville. "In this age of comparative effectiveness, this study shows that
when it comes to hysterectomy, a minimally invasive approach gives physicians
the opportunity to increase the quality of care women are receiving while
potentially saving the healthcare system millions of dollars. Clinicians who
have had concerns that minimally invasive procedures may be riskier for
patients should be reassured because this real-world data demonstrates the
overall complication rate is actually higher with the open abdominal
approach."

When compared with patients that underwent an open abdominal hysterectomy, the
vaginal approach was associated with an average cost-savings of more than
$4,000 and laparoscopic hysterectomy an average of $2,000 in cost-savings.
Among the three methods of hysterectomy, open abdominal hysterectomy remains
the most common approach as 70 percent(iii) of procedures are still performed
in this manner, despite the clear benefits of minimally invasive approaches.
The retrospective analysis was performed on 15,404 patients using claims data
from a large U.S. managed care plan. The results of the study, which was
sponsored by Ethicon Endo-Surgery, were published in the September issue of
TheJournal of Minimally Invasive Gynecology.

In similar findings, another study titled "Comparison of the Clinical and
Economic Outcomes Between Open and Minimally Invasive Appendectomy and
Colectomy: Evidence from a Large Commercial Payer Database" concluded
minimally invasive appendectomy and colectomy were associated with lower
infection rates, fewer complications, shorter hospital stays and lower
expenditures than open surgery. The results of the retrospective analysis,
which was also sponsored by Ethicon Endo-Surgery, has been accepted for
publication in the peer-reviewed journal Surgical Endoscopy and is currently
available on the journal's Web site. The data included analysis of 7,532
appendectomy and 2,745 colectomy procedures using a large commercial payer
database.

"This data strongly suggests that if someone needs a colectomy, regardless of
age, a minimally invasive procedure will result in fewer complications, get
them out of the hospital several days sooner and cost the healthcare system
$15,000 less than if the patient underwent open surgery," said Terrence
Fullum, M.D*., Associate Professor of Surgery at Howard University College of
Medicine and lead author of the study. "Unfortunately, there is a great
disparity between the number of colectomy procedures performed with open
surgery compared to minimally invasive procedures. This study is the latest in
a substantial and growing body of clinical and economic evidence that I
believe supports a call to action among the entire healthcare community to
increase access to the benefits of minimally invasive colectomy."

About "Open Abdominal versus Laparoscopic and Vaginal Hysterectomy: Analysis
of a Large United States Payer Measuring Quality and Cost of Care"

Investigators of the study collected data on intraoperative and postoperative
complications, length of stay, rates of readmission, and insurer and patient
payment totals for inpatient and outpatient procedures. Of 15,404 patients,
MIP was performed in 43 percent of subjects, with 23 percent (3,520)
undergoing laparoscopic hysterectomy, and 20 percent (3,130) a vaginal
hysterectomy. The study demonstrated that postoperative infection rates were
higher for patients undergoing open abdominal hysterectomy: 18 percent as
compared with 15 percent of laparoscopic and 14 percent of patients undergoing
vaginal hysterectomy (P<.05). With open abdominal hysterectomy, average length
of stay was 3.7 days versus 1.6 and 2.2 for patients undergoing MIP
laparoscopic and MIP vaginal hysterectomy, respectively.

In addition to the clinical benefits, the data indicated costs associated with
MIP were lower than for patients undergoing open abdominal hysterectomy.
Healthcare spending, represented as the expenditures for inpatient and
outpatient care associated with the procedure, included expenses related to
surgical and medical therapy. Adjusted expenditures associated with outpatient
MIP were markedly lower than expenditures for inpatient open abdominal
hysterectomy, indicating significant savings can be realized when patients can
be treated with an MIP procedure in an outpatient setting rather than
undergoing an inpatient procedure - MIP or open. When adjusting for the
setting, the cost of outpatient laparoscopic hysterectomy averaged $9,426 and
vaginal hysterectomy $7,627 compared to $11,739 for inpatient open
hysterectomy.

About "Comparison of the Clinical and Economic Outcomes Between Open and
Minimally Invasive Appendectomy and Colectomy: Evidence from a Large
Commercial Payer Database"

Investigators analyzed medical and pharmacy claims data from a large U.S.
managed health care insurer and measured post-operative infection rates,
procedure-specific complications, length of hospital stay, readmission rates
and expenditure rates. The data included 2,745 patients who underwent
colectomies; 842 (31 percent) were treated using a minimally invasive approach
whereas 1,903 (69 percent) underwent open surgery. Post-operative infection
rates for those who underwent an MIP were lower (24 percent) than those who
had open surgery (38 percent) as were minor (17 percent vs. 23 percent) and
major bleed rates (4 percent vs. 10 percent). When measuring the predicted
length of stay (with adjustments for factors such as surgical approach,
patient age, and co-morbidities), the data indicated open surgery resulted in
a length of stay four days longer when compared to MIP. Overall, the
investigators concluded minimally invasive colectomy procedures were
associated with a cost of care $15,200 less than open surgery.

When assessing these same outcomes for open and minimally invasive
appendectomies the investigators found similar results. The data on 7,532
patients who underwent appendectomies included 5,304 (70 percent) who
underwent an MIP and 2,228 (30 percent) treated with open abdominal surgery.
Post operative infection rates (16 percent for MIP vs. 20 percent for open)
and overall procedure specific complication rates (2.51 percent for MIP vs.
3.82 for open) were lower for minimally invasive procedures when compared with
open surgery. Additionally, minimally invasive appendectomy was associated
with a lower cost of care ($700) and about a half day shorter hospital stay
(3.27 vs. 3.91 days) than open surgery.

About Ethicon Endo-Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets
advanced medical devices for minimally invasive and open surgical procedures,
focusing on procedure-enabling devices for the interventional diagnosis and
treatment of conditions in general and bariatric surgery, as well as
gastrointestinal health, gynecology and surgical oncology. More information
can be found at www.ethiconendo.com.

*Paid consultant for Ethicon Endo-Surgery

(i) Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open Abdominal versus
Laparoscopic and Vaginal Hysterectomy: Analysis of a Large United States Payer
Measuring Quality and Cost of Care. Journal of Minimally Invasive Gynecol.
2009; 581-587.
(ii) Fullum TM, Ladapo JA, Borah BJ, Gunnarsson CL. Comparison of the clinical
and economic outcomes between open and minimally invasive appendectomy and
colectomy: evidence from a large commercial payer database. Surgical Endoscopy
2009 (published online).
(iii) Babalola E, Bharucha AE, Schleck CD, Gebhart JB, Zinsmeister AR, Melton
LJ 3rd. Decreasing utilization of hysterectomy: a population-based study in
Olmsted County, Minnesota, 1965-2002. Am J Obstet Gynecol. 2007;196:214-217.

SOURCE Ethicon Endo-Surgery

Wendy Dougherty for Ethicon Endo-Surgery, +1-513-337-8281