Abstract
Introduction:
We compared the cost-effectiveness of laparoscopic simple prostatectomy (LSP) vs open prostatectomy (OP).
Patients and Methods:
A total of 73 men treated for benign prostatic hyperplasia were enrolled for OP and LSP in groups 1 and 2, respectively. The findings were recorded perioperative, including operation time (OT), blood lost, transfusion rate, conversion to the open surgery, and the complications according to the Clavien Classification. The postoperative findings, including catheterization and drainage time, the amount of analgesic used, hospitalization time, postoperative complications, international prostate symptom score (IPSS) and International Index of Erectile Function (IIEF) scores, the extracted prostate weight, the uroflowmeter, as well as postvoiding residual (PVR) and quality of life (QoL) score at the postoperative third month, were analyzed. The cost of both techniques was also compared statistically.
Results:
No statistical differences were found in the preoperative parameters, including age, IPSS and QoL score, maximum flow rate (Qmax), PVR, IIEF score, and prostate volumes, as measured by transabdominal ultrasonography. No statistical differences were established in terms of the OT and the weight of the extracted prostate. No differences were established with regard to complications according to Clavien's classification in groups. However, the bleeding rate was significantly lower in group 2. The drainage, catheterization, and hospitalization times and the amount of analgesics were significantly lower in the second group. The postoperative third month findings were not different statistically. Only the Qmax values were significantly greater in group 2. While there was only a $52 difference between groups with regard to operation cost, this difference was significantly different.
Conclusion:
The use of LSP for the prostates over 80 g is more effective than the OP in terms of OT, bleeding amount, transfusion rates, catheterization time, drain removal time, hospitalization time, consumed analgesic amount, and Qmax values. On the other hand, the mean cost of the LSP is higher than OP. Better effectiveness comes with higher cost.
Introduction
B
Minimally invasive interventions can decrease the negative effects of open surgery for BPH, but are limited by gland size due to the risk of the inadequacy of ablation of the prostatic adenoma. 3 Thus, a new and minimally invasive technique that is potentially equivalent to OP has been developed—laparoscopic adenomectomy. According to the recent studies, laparoscopic simple prostatectomy (LSP) is a feasible and minimally invasive technique. 4 –10 There are many kinds of treatment modalities and types of BPH surgeries such as TURP, OP, holmium laser enucleation (HoLEP), and LSP. We believe that the success rate of treatment depends not only on the methods but also on the ancillary equipment or devices that facilitate the operation and decrease complications—especially in minimally invasive cases. However, the surgical equipment affects the cost of the operation. Thus, the cost of the treatment modality may be important when deciding on the type of treatment as well as its clinical utility. In this study, we aimed to audit the cost of LSP vs OP and to analyze their relative initial outcomes and cost.
Patients and Methods
This study was a retrospective trial. Between 2007 and 2015, a total of 73 men aged 49 to 95 years with lower urinary tract symptoms (LUTSs) were treated by one surgeon (H.V.) who had experience with at least 1000 laparoscopic surgeries, including laparoscopic radical or partial nephrectomy, pyeloplasty, laparoscopic radical prostatectomy, and cystectomy, as well as LSP and OP. The cases were enrolled as two groups: OP and LSP or groups 1 and 2, respectively. Permission to perform the study was given by the Regional Ethics Committee. Informed consent was received from all patients. Our routine investigation methods for patients with LUTSs are digital rectal examination, administration of the international prostate symptom score (IPSS) form, quality of life (QoL) score, International Index of Erectile Function (IIEF) form, urine analysis and urine culture, total and free prostate specific antigen levels, uroflowmetric analysis, and postvoiding residual (PVR), as well as abdominal ultrasonography (USG). The inclusion criteria for surgical treatment are IPSS >10, maximum flow rate <10 mL/second, PVR >200 cc, a history of acute urinary retention more than two times, recurrent urinary tract infection history, and active macroscopic hematuria of prostatic origin. The exclusion criteria were urethral stricture without BPH and prostate cancer.
The perioperative findings included operation time (OT), blood lost, transfusion rate, and conversion to the open surgery. These complications were analyzed according to Clavien Classification. The findings that were recorded in the postoperative follow-up interval include catheterization and drain time, amount of analgesic used, hospitalization time, complications according to the Clavien Classification, postoperative IPSSs and IIEF scores, the extracted prostate weight, uroflowmeter data, and PVR and QoL scores at the third postoperative month.
Cost analysis method
We audited the surgeon's fee, the fee of hotel service during the patient's hospitalization time, the fee of the used blood in case of blood transfusion, and the fee of additional operations such as internal urethrotomy for urethral or bladder neck stenosis if needed during follow-up interval. We also included the irrigation fluid fee, the fee of the used whole laparoscopic devices, and CO2 gas, as well as the items specific to group 1 used in group 2. We did not audit the fee of the used same items in both operations, including the fee of antibiotics and foley catheter. The results were compared statistically.
Statistical analyses
Results are given as mean ± standard deviation. Data were analyzed using SPSS-16 for Windows (SPSS, Inc.). Statistical analyses of the means of continuous variables were performed with Student's t-test and a Mann–Whitney U test in the case of nonhomogenic distribution. Categorical variables were analyzed using chi-square tests, and a probability level of p < 0.05 was considered as significant.
Results
The number of patients was 26 and 45 for groups 1 and 2, respectively. The characteristics are shown in Table 1. No statistical differences were established in terms of all preoperative parameters, including age (year), IPSS and QoL score, Qmax (mL/sn), PVR (cc), IIEF score, and prostate volumes, as counted by transabdominal USG (p > 0.05; Table 1). None of the laparoscopic cases converted to open surgery. OT and the weight of the extracted prostate that were recorded as perioperative findings were not statistically different between groups. OT results were 106.92 ± 29.9 minutes vs 123.22 ± 35.9 minutes for groups 1 and 2, respectively (p = 0.055, Table 1). The results of the extracted prostate weight were 103.15 ± 33.71 g vs 94.43 ± 44.31 g for groups 1 and 2, respectively (p = 0.39, Table 1). No differences were established with regard to complications according to the Clavien Classification. However, the bleeding rate that was a perioperative finding was significantly lower in group 2. The bleeding rates of the groups were 531.54 ± 191.137 cc and 127.78 ± 62.21 cc for groups 1 and 2, respectively (p = 0.001, Table 1). The hemoglobin (Hb) differences and transfusion rates established at the postoperative period were also significantly lower in the second group. The Hb differences for the first and second groups were 2.3 ± 1.24 and 1.2 ± 0.56, respectively (p = 0.001) (Table 1). The transfusion rates for groups 1 and 2 were 10 (38.4%) and 2 (4.4%), respectively (p = 0.001, Table 1). There were no differences between groups with regard to postoperative complications (p = 0.27, Table 1). Drainage, catheterization, and hospitalization times were each significantly lower in the second group. Drainage times were 6.19 ± 2.53 days and 2.25 ± 0.78 days for groups 1 and 2, respectively (p = 0.001, Table 1). Catheterization times were 9.77 ± 2.55 days and 6.34 ± 0.47 days, respectively (p = 0.001, Table 1), and hospitalization times were 7.15 ± 2.76 days vs 5.11 ± 2.06 days for groups 1 and 2, respectively (p = 0.001, Table 1). The amount of analgesics consumed during hospitalization time was also statistically lower in the second group, 308.65 ± 64.7 g and 227.33 ± 56.66 g for groups 1 and 2, respectively (p = 0.001, Table 1).
Hb = hemoglobin; IIEF = International Index of Erectile Function; PVR = postvoiding residual urine volume; Qmax = maximum flow rate.
At 3 months postoperative, no statistically significant differences were recorded with regard to IPSSs, QoL scores, and PVR. The IPSSs were 7.12 ± 2.14 and 6.96 ± 2.21 for groups 1 and 2, respectively (p = 0.76, Table 1), and QoL scores were 1.15 ± 0.46 and 0.91 ± 0.55, respectively (p = 0.06, Table 1). However, the Qmax values were significantly greater in group 2—21.62 ± 3.94 mL/second and 24.04 ± 4.75 mL/second for groups 1 and 2, respectively (p = 0.03, Table 1). No incontinent patients were seen at the third postoperative month.
The costs of the devices used in LSP per case are shown in Table 2. The cost difference between groups is only $52, but significant ($344.23 ± $38.43 vs $396.62 ± $258.24 for groups 1 and 2, respectively; p = 0.001, Table 3).
Discussion
Economic assessment methods such as the cost-effectiveness analysis (CEA) can provide the most efficient distribution of healthcare resources. Indeed, this is one of the first purposes of new interventional procedures. A fundamental view of CEA is essential to achieving a proper balance between good patient care and reasonable cost containment. 11,12 Economic assessments in health services determine the value of the cost associated with new interventions. The CEA is one of many different types of economic assessments, including cost minimization analysis, cost–benefit analysis, and cost–utility analysis. 13 To understand the cost-effectiveness of a new intervention, it must be compared with at least one other procedure. Typically, the new intervention under evaluation is compared with the commonly used intervention, and two estimates must be described: the extra cost and the extra effect of the new modality. This situation has four possibilities when comparing the two modalities. The new method can be more expensive and more effective (1), more expensive and less effective (2), less expensive and less effective (3), and finally less expensive and more effective (4). 14 The second category is dominated by the other alternatives because no one would pay for a less beneficial service. New modalities that fall into the fourth category are considered dominant and offer health gains at a lower cost. The CEA helps assess modalities that fall into the other two categories. The CEA helps with this decision and estimates the additional cost per unit of additional gain. 15
Although there is no strong evidence in the literature regarding the upper size limit of a prostate suitable for TURP, 16,17 OP should be considered when the prostate is estimated to have a volume of more than 80 mL (according to the EAU guideline, OP should be performed for prostates >80 mL 17 ) as well as in some mandatory situations related to patients' comorbidities such as ankylosis of the hip or other orthopedic conditions preventing proper positioning for TURP and in men with recurrent or complex urethral conditions, such as urethral stricture or previous hypospadias repair, to avoid urethral trauma associated with TURP. 2,17 According to our cost analysis, the cost difference is statistically significant, but it is minimal. So, the surgical techniques such as TURP, OP, or LSP depend on surgeon's preference and experience, as well as the conditions of the hospital.
Laparoscopy has recently shown promise in urology. Since Van Velthoven et al. 6 established the feasibility of LSP (Millin's procedure), some centers have started LSP for BPH and published their results related to LSP. 3 –5,7 –10 We believe that a new intervention technique that is candidate as a gold standard for any surgery should be considered with regard to cost of the new techniques as well as its success rates. Our research may be the first to compare initial outcomes and cost of OP and LSP for BPH.
No significant differences were found between the two groups with regard to age, IPSS, quality of life score, Qmax, PVR, IIEF score, and prostate volumes (Table 1, p > 0.05). When we compared the mean prostate volumes with others, 4,5,7,9,18 we found that the mean prostate volumes for OP in our study are the biggest. This can be important in terms of comparing OT, bleeding, and transfusion rates, as well as complications.
There was no significant difference in terms of mean OT between groups (Table 1, p > 0.05). Our mean OT values are nearly similar to others. 4,5,7,9,18 Our OT for OP and LSP (106.92 ± 29.9 minutes and 123.22 ± 35.9 minutes for groups 1 and 2, respectively, p = 0.055) is similar to Porpiglia and colleagues. 4 That is, there was no statistical difference between their groups with regard to OT (95.5 ± 22.5 minutes and 107.25 ± 34.9 minutes for OP and LSP, respectively [p = 0.6]). However, other studies have shown a difference. 7,18 McCullough and coworkers showed that OTs for OP and LSP were 54.7 ± 19.7 minutes and 95.1 ± 32.9 minutes, respectively (p < 0.0001). 7 According to the Garcia-Segui and Gascon-Mir study, the mean values for the same parameter were 101.2 and 135.2 minutes for OP and LSP, respectively (p = 0.022). 18 The differences among these studies may depend on the differences between prostate volume and the number of cases and may be case dependent in terms of anatomical variations.
We found no statistically significant differences in terms of removed prostate weight (g) between groups (p = 0.39, Table 1). Our comparative results were similar to Porpiglia and colleagues, 4 Quan and coworkers, 9 and Garcia-Segui and Gascon-Mir studies. 18
The bleeding amount was significantly lower in group 2 (531.54 ± 191.137 cc and 127.78 ± 62.21 cc for groups 1 and 2, respectively (p = 0.001) (Table 1). Our comparative results were similar to Porpiglia and colleagues, 4 Quan and coworkers, 9 and Garcia-Segui and Gascon-Mir studies. 18 However, McCullough and coworkers showed no statistical difference between OP and LSP (400 cc vs 350 cc, p = 0.387). These differences between different studies may be associated with the operation technique or anatomical variations among the cases and also according to our results; the difference with regard to the bleeding rates between the two techniques can be associated with a technological device such as harmonic scalpel and the dissection underview, as well as surgeon's experience especially for LSP.
According to our postoperative findings at the first week, Hb differences, transfusion rates, catheterization time, drain removal time, and hospitalization time were significantly lower in group 2 (Table 1). Catheterization time was also significantly different according to McCullough and coworkers 7 (6.4 ± 2.9 days and 5.2 ± 2.6 days for OP and LSP, respectively, p = 0.001), Quan and coworkers 9 (5.6 ± 1.1 days and 3.1 ± 0.4 days for OP and LSP, respectively, p = 0.001), and Garcia-Segui and Gascon-Mir 18 (7.5 and 5.52 days for OP and LSP, respectively, p = 0.03). However, Porpiglia and colleagues reported no statistical difference in terms of catheterization time (5.6 ± 1.1 days and 6.3 ± 3.7 days for OP and LSP, respectively, p = 0.9).
Our data for hospitalization time were similar to the literature (7.15 ± 2.76 days and 5.11 ± 2.06 days for OP and LSP, respectively, p = 0.001) in the Quan and coworkers study 9 (7 ± 1.6 days and 3.5 ± 0.8 days for OP and LSP, respectively, p = 0.001) and Garcia-Segui and Gascon-Mir study 18 (6.6 and 3.7 days for OP and LSP, respectively, p = 0.006). Porpiglia and colleagues found no difference in hospital stay, which differs from our result and results of some studies in the literature. 4,9,18 The hospitalization time had not been compared in some comparative studies in the literature. These differences in terms of both p values, catheterization time, and hospitalization time among the studies may depend on surgeon's preferences and may be case dependent. There was no standardization in catheterization time and hospitalization time. This is also valid for drain removal time. This parameter had not been included in other prior comparative studies.
We found that the rate of incontinence was significantly lower in the LSP group (Table 1). This result may be associated with less damage to the external sphincter and tissue because of the dissection underview. The amount of analgesics used had been studied only once, 4 but they found no difference between approaches in contrast to our results (Table 1).
At the third month after surgery, only Qmax was different, the IPSS, QoL score, PVR, and complications were not. The Qmax values for the groups were 21.62 ± 3.94 mL/second and 24.04 ± 4.75 mL/second for groups 1 and 2, respectively (p = 0.03, Table 1). This may depend on the clear dissection of the prostatic tissue under study.
While we did show a cost difference (p = 0.001, Table 3), this result is for our initial outcome. The most important factor that affected this result was the fee for laparoscopic equipment—especially the harmonic scalpel (Ultrascions; Ethicon, J&J) device. The service life of the ultrascions is case dependent. For that reason, the endurance of ultrascions can be changed according to the size of the prostate or difficulty of the operation. The fee of the used devices and other items per case is shown in Table 3. We excluded the fee of the trocars because of their common use in other laparoscopic surgeries.
Some advantages of LSP are seen and understood when we take a general aspect. The parameters, including OT, bleeding amount, transfusion rates, catheterization time, drain removal time, hospital stay, and consumed analgesic amount, were lower in the laparoscopic surgery group. We performed an LSP after the 26th case of OP. Although we did not find any statistically significant difference in terms of complications between groups, we believe that the complication rates may increase if the OP number increases. In addition, the decrease in bleeding amount and transfusion rates decreases the complications that result from blood transfusion. This situation can automatically affect hospitalization time. In addition, catheterization time, drain removal time, and hospitalization time can affect the infection rates and indirectly the cost. The cost and psychology of the patients can be affected by these situations. Patients in this population do not want to stay in the hospital for a long time. Thus, we must also consider the psychological implications.
According to the effectiveness model described by Hoch and Dewa, 15 our study falls into the first category, that is, more expensive and more effective. CEA helps with this decision by estimating the additional cost per unit of additional gain.
Lack of study
The first limitation of our study is that we could not analyze long-term complications that require further treatment. The main reason for patients who underwent surgery not coming to the study center unless they have a complaint is the distance between their home and the study center. The second limitation of our study is that the results of our work may not be valid for every situation, hospital, or country because there is no standardization among hospitals (especially for private hospitals) in terms of price policy for these subjects. The third one, the number of patients of our study is small for making significant decisions. Finally, cost analysis was not done by a chartered accountant.
Conclusion
It seems that usage of LSP technique for greater than 80 g prostates is more effective than OP in terms of OT, bleeding amount, transfusion rates, catheterization time, drain removal time, hospitalization time, consumed analgesic amount, and the value of Qmax.. On the other hand, the mean cost of LSP seems to be more expensive than OP. Urologists should consider these parameters before selecting a treatment modality. Higher effectiveness has higher cost. According to our results, we concluded that if the technological equipment of hospitals is suitable, the first choice may be LSP for larger prostates if the surgeon has enough experience.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
