Hospital Cost Savings Associated with the Use of an Adhesion Barrier During Cesarean Delivery

Abstract

Objective: The aim of this study was to model the budget impact on a hospital that incorporated use of an adhesion barrier in cesarean section (CS) surgery. Design: The study used an economic model assuming 1000 CS births in the model year, incorporating Gynecare Interceed^® as the standard of care. Materials and Methods: The base case model included the following assumptions (derived from literature and publically available information): presence of adhesions=50%; $50/minute of operating room time; average increase in length of stay of 1.4 days for a CS with complications; mean cost/stay of $7,600 for CS with complications, compared to $5,700 for a CS without complications; cost of Gynecare Interceed^® (Ethicon, West Somerville, NJ)=$250. A two-way sensitivity analysis was performed to test the base case model. Results: Assuming 1000 CS births took place in the model year, with 500 complicated by adhesions, the total cost of adhesions to the facility was $1,807,500/year. The cost of Gynecare Interceed/year was $250,000. Therefore, the cost savings of using Gynecare Interceed was $837,500/year. The results of the sensitivity analysis upheld the original model results. Even using conservative estimates, hospitals would still realize a cost savings of $37,999/year using Gynecare Interceed. Conclusions: This model demonstrates the cost savings to a hospital of incorporating the use of Gynecare Interceed as a standard of care in CS. Even applying conservative view, the results of the model clearly demonstrated the role of Gynecare Interceed as a cost-saving mechanism. (J GYNECOL SURG 28:207)

Introduction

Adhesions are fibrous bands that form between tissues and organs during healing from surgery. Pelvic adhesions can form as a result of inflammation, endometriosis, or surgical trauma.¹ The risk of adhesions after gynecologic surgery is common—adhesions occur in more than 90% of patients following major abdominal surgery and in 55%–100% of women undergoing pelvic surgery.² The likelihood of adhesion formation and the seriousness of its consequences are based on many factors (e.g., type of surgery, number of previous surgeries, surgical technique, and predispositions of individual patients). However, studies have shown consistently that a majority of women who have gynecologic surgery will have some degree of adhesion formation, as this surgery is the most common cause of adhesions.

The Healthcare Cost and Utilization Project (HCUP) data for 2008 (the most recent year with data available) reported that there were 4.2 million births in the United States, and of those births, 33% were by cesarean section (CS). The rate of repeat CS was 14%.³ Adhesion formation in CS is common and increases with the number of CS births, from 24% to 46% after the first delivery to up to 43%–83% following the fourth delivery.^4,5 A recent study found significantly more dense adhesions to the bladder and to the abdominal wall after two or more CSs (46.3% and 48.2, respectively) than after one CS (29.8% and 25.6%, respectively). The adhesions on these areas were also more severe after 2 or more CSs than after one CS.⁶

The high incidence of postsurgical adhesions and their clinical consequences result in high costs to the health care system. A 2005 study reported that 57,005 days of inpatient care and $220 million in additional costs were attributable to female reproductive system adhesiolysis.⁷ Adhesions have also been shown to affect time to birth in cesarean section. When adhesion prevention was not used, adhesions increased operating room time from an average of 8.9 minutes for the first CS to 18 minutes by the fourth CS.⁴ Similarly, Tulandi et al.⁵ found that, compared with a first CS (7.7 minutes), the delivery time was significantly longer at subsequent CSs (second CS=9.4 minutes; third CS=10.6 minutes; ≥4 CSs=10.4 minutes). A latter study found a significant correlation between adhesion severity and the interval between the incision and delivery (r=0.23, p<0.0001) and the operating time (r=0.26, p<0.0001), indicating that the more severe the adhesion was, the longer the CS took to perform.⁶

The incidence of postoperative adhesions can often be reduced. It is important to prevent adhesions, because once they form, they tend to recur, even after they have been surgically removed. The use of a barrier during surgery to protect tissue surfaces as they heal has been shown to be one of the most effective methods of reducing adhesions. The most widely studied strategies include placing synthetic barrier agents between the pelvic structures.⁸ A recent study showed that using an adhesion barrier reduced adhesions during CS, with 74% of women in whom it was used having no adhesions, compared to 22% in patients without use of an adhesion barrier.⁹ In addition, when an adhesion barrier was used and adhesions occurred, they tended to be of a lower grade than the adhesions that formed in the absence of a barrier.

Gynecare Interceed^® (Ethicon, Inc., West Somerville, NJ) is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved.¹⁰ A recent Cochrane Review of 16 randomized controlled trials of adhesion barriers concluded that Gynecare Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy.¹¹

Materials and Methods

Study design

This study modeled the cost savings to a hospital of incorporating use of Gynecare Interceed^® in CS surgery.

CS assumptions

Table 1 shows the assumptions made in the base case model. Our base case model assumed that 1000 CS births were performed in the model year. The presence of adhesions was set at 50%, the approximate midpoint (range=24%–83%) of rates found in the literature.^4,5 Therefore, the base case estimated that 500 CS births complicated by adhesions took place.

Table 1.

Base Case Model Inputs

Variables	Amounts
Hospital inputs
# of CS/year in facility	1000
% of patients with adhesions during CS	50%
# of patients with adhesions during CS	500
# of additional minutes in the OR for CS with adhesions	5.5
Average OR cost/minute	$50.00
Cost per hospitalization
Mean cost/stay—CS without complications	$5,700.00
Mean cost/stay—CS with complications	$7,600.00
Cost of Gynecare Interceed^®a
Average Gynecare Interceed cost per sheet	$250
Number of sheets used per CS	1

Ethicon, Inc., West Somerville, NJ.

CS, cesarean section; OR, operating room.

A study by Chapa et al.⁹ found that the mean time from initial incision to birth decreased with the use of an adhesion barrier, from 10.2 minutes with a barrier to 15.7 minutes without a barrier. Therefore, the base case model assumed an increase of 5.5 minutes in the presence of adhesions.

Cost estimates

Charges for most U.S. operating room services generally depend on the complexity of the particular operation. By convention, there is an initial charge as well as a per-minute charge while the operation is being performed. Operating room costs vary depending on hospital. One study estimated operating room costs to be $20.83/minute at the author's hospital.¹² However, this rate is lower than rates posted on the internet by some hospitals. Cleveland Clinic has posted operating room charges ranging between $1,769 and $3,336 per 30-minute block,¹³ while Ohio Health's charges range from $3,981 to $7,319 per 30 minute block.¹⁴ Therefore, a more-realistic estimate of operating room cost/minute may be anywhere from $59 to $234. The base case model used a conservative rate of $50/minute of operating room time.

In addition to operating room time, length of stay may also be affected by the presence of adhesions. The HCUP data for 2008 found that the average length of stay for a CS without complications was 3.1 days, compared to 4.5 days for a CS with complications.³ In addition, the mean cost per stay for CS without complications was $5,700 while that amount rose to $7,600 for CS with complications.³ These dollar figures were used as inputs to the model base case.

The cost of Gynecare Interceed was set at $250, which is the average sales price for one sheet. The model assumed that only one piece of Interceed would be needed during the CS surgery (Table 1).

Sensitivity analysis

A sensitivity analysis (Table 2) adjusted for the presence of adhesions during CS delivery, using the lower (24%) and upper limits (83%) found in the literature,^4,5 which varied the percentage of CS deliveries from 240 to 830 per year based on a hospital performing 1000 CS surgeries in a given year.

Table 2.

Sensitivity Analysis Model Inputs

Variables	Amounts
Hospital inputs
# of CS/year in facility	1,000
% of patients with adhesions during CS	24–83%
# of patient with adhesions during CS	240 to 830
# of additional minutes in the OR for CS with adhesion	1.7 to 9.1
Average OR cost per minute	$21 to $234
Cost per hospitalization
Mean cost/stay—difference between no complications and complications	$1,425–$2,375
Cost of Gynecare Interceed^®a
Average Gynecare Interceed cost per sheet	$187.50–$312.50
Number of sheets used per CS	1

Ethicon, Inc., West Somerville, NJ.

CS, cesarean section; OR, operating room.

For the sensitivity analysis, the increase in surgical time was also adjusted, with adhesions based on the shortest (1.7 minutes⁵) and longest variances (9.1 minutes⁴) found in the literature. Operating room cost per minute was adjusted from a low of $20¹² to a high of $234¹⁴ for the sensitivity analysis. Mean cost per stay was adjusted during the sensitivity analysis by 25% in each direction (low=$1425; high=$2375). The cost of Gynecare Interceed was also varied during the sensitivity analysis, by 25% in each direction (low=$187.50; high=$312.50). See Table 2.

Results

Base case

Using an operating room cost/minute of $50 and the assumption that nonuse of an adhesion barrier adds 5.5 minutes to each CS delivery, the additional operating room cost attributable to adhesions is $275 per CS (5.5 minutes×$50). The cost per stay of CS with complications was $1,900 more than CS without complications. This amounted to a total of $2,175 in extra cost per CS delivery with adhesions. Assuming that 1000 CS births took place in the model year, with 500 of those births complicated by adhesions, the total cost of adhesions to the facility was $1,807,500/year.

The cost of Gynecare Interceed per year for the hospital was $250,000, assuming that one sheet was used in every CS delivery ($250/sheet for 1000 CS births). Therefore, the cost savings of using Gynecare Interceed was $837,500 per year (Table 3).

Table 3.

Base Case Results

Description	Input
Additional cost of OR time attributable to adhesions	$275
Additional cost of hospital stay with adhesion	$1,900
Additional cost/CS delivery (sum of above 2 lines)	$2,175
Cost of adhesions/year to facility	$1,807,500
Cost of Gynecare Interceed^®a per year	$250,000
Cost savings associated with Gynecare Interceed	$837,500

Ethicon, Inc., West Somerville, NJ.

OR, operating room; CS, cesarean section.

Sensitivity analysis

A two-way sensitivity analysis was performed. A very conservative analysis assumed that 24% of the 1000 CS births would be complicated by adhesions. Using an operating room cost/minute of $21, with adhesions adding an additional 1.7 minutes per CS delivery, the additional operating room cost attributable to adhesions was $35/CS (1.7 minutes×$21). The additional cost per stay of CS with complications was lowered by 25% to $1,425. This amounted to a total of $1,460 in extra cost per CS delivery with adhesions. Assuming 1000 CS births took place in the model year, and 240 (24%) were complicated by adhesions, the total cost of adhesions to the facility would be $350,499/year.

The cost of Gynecare Interceed per year for the hospital was $312,500, assuming that one sheet was used in every CS delivery ($312.50/sheet for 1000 CS births). Even with these very conservative estimates, the hospital would still realize a cost savings of $37,999/year using Gynecare Interceed.

In addition, a high-end variance was also performed. Using an operating cost/minute of $234, with adhesions adding an additional 9.0 minutes per CS delivery, the additional operating room cost attributable to adhesions was $2,106 per CS (9.0 minutes×$234). The additional cost/stay of CS with complications was raised by 25% to $2,375. This amounted to a total of $4,481 in extra cost per CS delivery with adhesions. Assuming 1000 CS births took place in the model year, and 830 (83%) were complicated by adhesions, the total cost of adhesions to the facility would be $3,719,230/year.

The cost of Gynecare Interceed per year for the hospital was lowered by 25% and was $187,500, assuming that one sheet was used in every CS delivery ($187.50 per sheet for 1000 CS births). In this scenario, the hospital would realize a cost savings of $3,531,730 per year using Gynecare Interceed (Table 4).

Table 4.

Sensitivity Analysis Results

Description	Low estimate	High estimate
Additional cost of OR time attributable to adhesions	$35	$2,106
Additional cost of hospital stay with adhesion	$1,425	$2,375
Additional cost/CS delivery (sum of above 2 lines)	$1,460	$4,481
Cost of adhesions per year to facility	$350,499	$2,719,230
Cost of Gynecare Interceed^®a per year	$312,500	$187,500
Cost savings associated with Gynecare Interceed	$37,999	$3,531,730

Ethicon, Inc., West Somerville, NJ.

OR, operating room; CS, cesarean section.

Discussion

HCUP estimated that there were 1.38 million cesarean births in the United States in 2008, and the percentage of births via CS keeps increasing.³ In addition, many CS births are increasing as the rate of vaginal birth after cesarean section is declining over time.³ Adhesion formation with CS is common and increases in both percentage and severity with the number of CS births.⁶ Adhesion barriers have been shown to reduce the presence of adhesions in CS.¹¹

This model demonstrates the cost savings to a hospital of incorporating the use of Gynecare Interceed as a standard of care in CS. Using moderate assumptions in the base case model, a hospital that performs 1000 CS surgeries per year would save $837,500 annually. Even when taking an extremely conservative view, the results of the model demonstrated clearly the role of Gynecare Interceed as a cost-saving mechanism.

Adhesion barriers do not prevent all adhesions. The efficacy of such barriers is limited to surgical situations in which the surgical site can be completely covered. Effective application is limited by technical difficulties, including the need for hemostasis and removal of excess peritoneal fluid. However, numerous studies have demonstrated that Gynecare Interceed is effective in adhesion reduction. A Cochrane review summarized evidence from 16 randomized clinical trials of adhesion prevention methods, and found that the use of Gynecare Interceed was associated with reduced incidence of pelvic adhesion formation, both new formations and reformations following laparoscopic surgery or laparotomy.¹¹ Furthermore, Wiseman et al.¹⁵ found that among Gynecare Interceed/Oxidized Regenerated Cellulose (ORC)–treated patients, more than half did not have further adhesions after adhesiolysis, compared to ∼24% without Gynecare Interceed/ORC treatment. After reviewing the data for all patients in the study, Wiseman et al. concluded that ORC/Gynecare Interceed was 1.6 to 2.5 times more effective than good surgical care alone for preventing adhesions.

Studies of ovarian surgery have also demonstrated efficacy of Gynecare Interceed. One study showed that Gynecare Interceed reduced the occurrence and severity of postsurgical ovarian adhesions significantly.¹⁶ Similarly, an Austrian study found that significantly fewer adhesions formed on ovaries, fallopian tubes, and filmbriae when the organs were covered with Gynecare Interceed.¹⁷ Furthermore, Sawada et al.¹⁸ found that Gynecare Interceed use reduced the rate of adhesion formation significantly following gynecologic surgery with a statistically significant increase in susequent pregnancy rate, compared to the surgical controls.

There are several limitations to this model. First, the assumptions used in this model were based on published literature. Actual utilization at facilities across the United States may or may not reflect what has been published. This model also assumes that 50% of women undergoing CS will get adhesions; therefore, the other 50% of these women would receive Gynecare Interceed unnecessarily. However, there are no clear clinical markers for distinguishing which patients are more likely to get adhesions, except for the presence of adhesions from past surgery, and, therefore, treating the entire population is necessary. The model demonstrates that, although 50% of the women would receive Gynecare Interceed without needing it, cost savings to the system would still be realized. This model assumes further an operating room cost/minute of $50 and the assumption that nonuse of an adhesion barrier adds 5.5 minutes to each CS delivery. Therefore, the additional operating room cost attributable to adhesions is $275 per CS, which is just $25 higher than the cost of Gynecare Interceed itself, and would amount to a small cost savings ($2,500 per year) to the hospital. However, when adding in the other additional costs, such as increased length of stay, a considerable cost savings was demonstrated.

This model also does not address specific complications resulting from adhesions (e.g., bladder injury) and the cost of treating those complications. However, if these costs were factored into the model, the cost savings associated with Gynecare Interceed would be likely to increase. Nor does the model address the cost of treating adhesiolysis adequately, and the effect of adhesions on multiple CS births, but this would also increase the cost savings with Gynecare Interceed. A study published last year found that the presence of adhesions during CS birth added $300 per patient, compared with CS births not complicated by adhesions.¹⁹ This model also does not incorporate specific surgeon concerns, such as the need to reschedule other cases based on complications encountered during a CS. Again, omission of this information probably underestimated the true cost savings for the hospital and surgeon alike.

Cost savings would also be realized for the hospital by a reduction in the number of CS births, as adhesions are not a concern in vaginal birth. However, trends in births show that the rate of CS is actually increasing. The rate of CS births increased from 21% in 1997 to 33% in 2008, while vaginal births decreased during that same time period.³ It is unlikely that a reversal of this trend will take place, so preventing adhesion formation in CS in an imperative if costs to the health care system are to be reduced.

Conclusions

There are upfront costs of acquiring adhesion-barrier products, and these products are not reimbursable on a per-sheet basis in the United States. Instead, these costs are part of the overhead costs a hospital must absorb. Therefore, some hospitals have curbed their use to avoid excess costs. However, as shown in this model, the use of Gynecare Interceed saves a hospital money in the long run by reducing operating room time and lengths of stay.

In this era of health care reform, a greater emphasis is being placed on quality measures as a way to improve cost effectiveness of health care. In the accountable care organization (ACO) model, health care systems will be reimbursed better rates for better outcomes, and will be penalized for hospital-acquired conditions. The use of Gynecare Interceed as a quality-improvement strategy should be investigated and considered.

Footnotes

Disclosure Statement

This article was funded by Ethicon, Inc., manufacturer of Gynecare Interceed.^® Ms. Waters is an employee of Ethicon, Inc., and holds stock in Johnson & Johnson, the parent company of Ethicon Inc. Dr. Chapa is a medical consultant to Ethicon Inc.; however, no financial incentives were given to Dr. Chapa by Ethicon, Inc. for participation in this study.

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