Abstract
Background:
Radical prostatectomy (RP) is the first-line treatment modality for prostate cancer and can be performed using retropubic or minimally invasive techniques. New technologies such as the da Vinci robotic system and three-dimensional (3D) laparoscopic imaging system have been developed to overcome the challenges of conventional laparoscopy. This study aimed to compare the perioperative, oncological, and functional outcomes of robot-assisted laparoscopic RP (RALP) and 3D laparoscopic RP (3D LRP).
Materials and Methods:
The study was approved by the local ethics committee and included 65 patients (38 RALP, 27 3D LRP) who underwent RP with the diagnosis of localized prostate cancer between May 2019 and January 2020. All demographic, clinical, perioperative, pathological, and postoperative variables were recorded.
Results:
There was no statistically significant difference between the two groups in terms of preoperative patient characteristics. The mean operative times of the RALP and 3D LRP groups were 135.74 ± 11.51 and 165.37 ± 15.86 minutes, respectively, with a statistically significant difference between the two groups (P = .001). The mean estimated blood loss was 237 ± 71 mL in the RALP group and 257 ± 54 mL in the 3D LRP group, with no statistically significant difference between the two groups (P = .236). In the 6 months of follow-up, there was no statistically significant difference between the two groups in terms of biochemical recurrence, continence, and potency.
Conclusion:
RALP and 3D LRP have similar perioperative, short-term oncological and functional outcomes other than the operative time. There is a need for prospective, randomized studies with larger populations evaluating long-term oncological and functional outcomes.
Introduction
Prostate cancer is the second most common cancer and the fifth leading cause of death in men. 1 Several treatment options, including radical prostatectomy (RP), are currently available for men diagnosed with clinically localized prostate cancer. RP is recommended as the first-line therapy, especially for patients with a life expectancy of at least 10 years.2,3 Retropubic RP (RRP) is the standard procedure for the treatment of clinically localized prostate cancer; however, this procedure has limitations such as a considerable amount of blood loss, postoperative pain, and prolonged length of hospital stay. To overcome these limitations, Schuessler et al. first reported the results of laparoscopic RP (LRP) in the early 1990s.4,5 Three-dimensional (3D) laparoscopy was developed to overcome the drawbacks of two-dimensional (2D) imaging, one of the major limitations of conventional laparoscopic surgery. Current 3D laparoscopic technology provides an optical experience similar to open surgery, thanks to its high-definition 3D image. 6
Robot-assisted LRP (RALP) was introduced in 2000 to reduce the technical challenges of laparoscopic procedures and shorten the learning time. 7 Over the years, RALP has been widely adopted worldwide as a standard procedure for clinically localized prostate cancer, while LRP remained in the background. 8 In the United States, only 8% of patients undergoing RP were treated with RALP in 2004, while 67% of patients underwent RALP in 2010. 9 However, the major disadvantage of RALP is its cost, and studies have shown that RALP is associated with a significantly higher cost than RRP and LRP.10,11
In the literature, there are studies comparing conventional LRP with 3D LRP, and these studies have shown that 3D LRP provides significant advantages.6,12,13 However, to our knowledge, there is no prospective study in the literature comparing RALP with 3D LRP. In this study, we aimed to compare the perioperative, oncological, and functional outcomes of RALP and 3D LRP.
Materials and Methods
The study protocol was approved by the local Ethics Committee of Ataturk University Faculty of Medicine. The study included 65 patients who underwent RP with the diagnosis of localized prostate cancer between May 2019 and January 2020. Data of 27 patients who underwent 3D LRP by a single surgeon experienced in laparoscopy (more than 300 laparoscopic urological surgeries and more than 50 laparoscopic prostatectomy cases) in the Urology Clinic of Ataturk University and 38 patients who underwent RALP by 2 surgeons experienced in robotic surgery in the Urology Clinic of Erzurum Regional Training and Research Hospital were prospectively collected.
Surgical technique
All RALPs were performed using a four-arm da Vinci Xi Surgical System (Intuitive Surgical, Sunnyvale, CA, USA). RALP was performed transperitoneally with the Frankfurt technique described by Wolfram et al. using five trocars. 14 In brief, these steps were performed sequentially: dissection of the seminal vesicles, development of Retzius space, opening the endopelvic fascia, dorsal venous complex suture, transection of the bladder neck, dissection of the neurovascular bundle, and transection of the dorsal venous complex and urethra. The vesicourethral anastomosis was performed with the Van Velthoven technique using 3/0 V-loc (Covidien, Mansfield, MA, USA) suture.
All 3D LRPs were performed using the 3D Vision System (Wolf, Knittlingen, Germany). The procedure of 3D LRP was transperitoneally performed with the descending technique described by Rhee et al. using five trocars. 15 In brief, these steps were performed sequentially: development of the Retzius space, opening of the endopelvic fascia, dorsal venous complex suture, transection of the dorsal venous complex and urethra, dissection of the neurovascular bundle, dissection of the seminal vesicles, and transection of the bladder neck. The vesicourethral anastomosis was performed with the Van Velthoven technique using 3/0 V-loc (Covidien) suture.
In both procedures, neurovascular bundle sparing was selected according to the tumor location and invasion depth on multiparametric magnetic resonance imaging (mpMRI). As a rule, the patients were discharged after checking the leak by performing cystography before catheter removal. When a urine leak was detected, the urethral catheter was kept for another 5–7 days.
Study data
Digital rectal examination, mpMRI, and bone scan were used for the preoperative evaluation of the patients according to the European Association of Urology Guidelines on Prostate Cancer. For both procedures, the Briganti nomogram was used to decide on lymph node dissection (if the estimated risk for positive lymph nodes exceeds 5%) in moderate-risk disease. 16 All demographic, clinical, perioperative, pathological, and postoperative variables were recorded. The preoperative data included age, body mass index (BMI), serum prostate-specific antigen (PSA), Gleason score obtained from biopsy, D'amico risk group, prostate volume, and the presence of median lobe. The intraoperative data were operative time, the estimated blood loss, and intraoperative complications. Operative time was calculated as the time from the first incision to the removal of the prostate specimen. The postoperative data included the length of hospital stay, catheterization time, final pathology result, and postoperative complications. The Clavien–Dindo classification was used to evaluate postoperative complications. 17
During the follow-up, continence was evaluated immediately and at 3 and 6 months after catheter removal. No pad or one safety pad per day was considered continence. Pelvic floor exercises were recommended to all patients after catheter removal to provide urinary continence rehabilitation. After discharge, all patients were initiated on phosphodiesterase type 5 inhibitor 5 mg once daily. Potency was defined as the presence of erectile function sufficient to achieve sexual intercourse in more than 50% of attempts. Serum PSA was studied to evaluate biochemical recurrence (BCR) at postoperative 3 and 6 months. Two consecutive serum PSA values greater than 0.2 ng/mL were defined as BCR.
Statistical analysis
Statistical analysis was performed with IBM SPSS v20.0 (SPSS, Inc., Chicago, IL, USA) software package. The normality distribution of variables was checked with the Kolmogorov–Smirnov and histogram tests. Descriptive data were expressed as mean ± standard deviation or number. Categorical variables were analyzed using the Pearson chi-square test. Normally distributed data comprising continuous variables were analyzed using the Student's t-test or Fisher's exact test. For the statistical analysis, P < .05 was considered statistically significant.
Results
The mean ages of the RALP and 3D LRP groups were 63.76 ± 6.49 and 63.44 ± 8.26 years, respectively, and their mean BMI values were 26.03 ± 2.60 and 26.22 ± 2.54, respectively. The mean preoperative PSA was 7.55 ± 2.38 in the RALP group and 7.36 ± 1.19 in the 3D LRP group. Of the patients in the RALP group, 23 (61%) had a Gleason score of 3 + 3, 10 (26%) had a Gleason score of 3 + 4, and 5 (13%) had a Gleason score of 4 + 3, and 16 (42%) patients were in the low-risk group and 22 (58%) patients were in the intermediate-risk group. Of the patients in the 3D LRP group, 18 (67%) had a Gleason score of 3 + 3, 6 (22%) had a Gleason score of 3 + 4, and 3 (11%) had a Gleason score of 4 + 3, and 18 (67%) patients were in the low-risk group and 9 (33%) patients were in the intermediate-risk group. Thirty-three (87%) of the patients in the RALP group and 23 (85%) of the patients in the 3D LRP group were preoperatively potent. There was no statistically significant difference between the two groups in terms of preoperative patient characteristics (Table 1).
Comparison of Patients' Characteristics
3D LRP, three-dimensional laparoscopic radical prostatectomy; ASA, American Society of Anesthesiologist; BMI, body mass index; PSA, prostate-specific antigen; RALP, robot-assisted laparoscopic radical prostatectomy; SD, standard deviation.
The mean operative times of the RALP and 3D LRP groups were 135.74 ± 11.51 and 165.37 ± 15.86 minutes, respectively, with a statistically significant difference between the two groups (P = .001). The mean estimated blood loss was 237 ± 71 mL in the RALP group and 257 ± 54 mL in the 3D LRP group, with no statistically significant difference between the two groups (P = .236). None of the patients in both groups had bleeding requiring transfusion. There was no statistically significant difference between the two groups in terms of the number of patients who underwent the nerve-sparing procedure, the hospitalization time, and catheterization time (Table 2). Of the patients in the RALP group, 29 (76%) had pathological stage pT2, 7 (18%) had pT3a, and 2 (5%) had pT3b, while in the 3D LRP group, 21 (78%) patients had pathological stage pT2, 5 (19%) patients had pT3a, and 1 (4%) patient had pT3b. Positive surgical margin was found in 6 (16%) of the patients in the RALP group and in 5 (19%) of the patients in the 3D LRP group. There was no statistically significant difference between the two groups in terms of pathological parameters (Table 2).
Comparison of Surgical and Pathological Parameters
3D LRP, three-dimensional laparoscopic radical prostatectomy; RALP, robot-assisted laparoscopic radical prostatectomy; SD, standard deviation.
P < .05 was considered statistically significant.
None of the patients in both groups required conversion to open surgery. Four (11%) patients in the RALP group and 5 (19%) patients in the 3D LRP group developed complications, and although the 3D LRP group had a slightly higher complication rate than the RALP group, there was no statistically significant difference (P = .440). Six of these complications (67%) were Clavien–Dindo Grade 1 complications. One patient in the RALP group and 2 patients in the 3D LRP group had Clavien–Dindo Grade 3 complications requiring additional intervention (Table 3).
Comparison of Postoperative Complications According to Clavien Classification
3D LRP, three-dimensional laparoscopic radical prostatectomy; RALP, robot-assisted laparoscopic radical prostatectomy.
BCR was detected in 2 (5%) patients in the RALP group at 6 months. In the 3D LRP group, BCR was detected in 1 (4%) patient at 3 months and in 2 (7%) patients at 6 months. Immediate continence after catheter removal was detected in 14 (37%) patients in the RALP group and in 10 (37%) patients in the 3D LRP group and the 6-month continence rate was 92% in the RALP group and 93% in the 3D LRP group. The 6-month potency rate was 63% in the RALP group and 67% in the 3D LRP group. In the 6 months of follow-up, there was no statistically significant difference between the two groups in terms of BCR, continence, and potency (Table 4).
Comparison of Oncological and Functional Outcomes
3D LRP, three-dimensional laparoscopic radical prostatectomy; BCR, biochemical recurrence; RALP, robot-assisted laparoscopic radical prostatectomy.
Discussion
There is a general consensus that the goals of RP are, in order of importance, to cure cancer, maintain urinary continence, maintain erectile function, and minimize complications and perioperative pain. 18 In line with these goals, surgical approaches have undergone rapid changes and significantly evolved over the past two decades. 19 Minimally invasive RP (LRP and RALP) is associated with less bleeding, less transfusion rate, shorter length of hospital stay, less pain with activity in the first week, better physical quality of life at 6 weeks, and less distress at 12 weeks compared to RRP.20,21 Moreover, the improvement of the quality of intraoperative vision by magnifying the image in minimally invasive RP allows a more precise procedure. 22 As a result of all these advantages, as in many surgeries, interest in minimally invasive techniques in RP has increased all over the world and it can be speculated that this interest will continue to increase with the developing technology.
Despite its many advantages, laparoscopy has some technical and ergonomic disadvantages. These are the limited range of motion of laparoscopic instruments, poor depth perception in the 2D laparoscopic imaging system, and the long learning curve. To overcome these disadvantages, new technologies such as laparoscopic robotized needle holders that can mimic the surgeon's hand movements and 3D laparoscopic imaging systems have been developed. 23 The da Vinci robotic system provides 3D visualization, 10–15 times magnification, a wrested instrumentation, intuitive finger-controlled movements, and a comfortable sitting position for the surgeon. It provides optimum visualization and precision, facilitating tissue dissections, and sutures. Thus, it offers a shorter learning curve compared to laparoscopic surgery. 24 The da Vinci robotic system offers significant advantages, especially for RP. The vesicourethral anastomosis is one of the most challenging steps of the procedure due to exposure difficulty in RRP and the requirement for laparoscopic suturing in LRP. However, the da Vinci robotic system greatly facilitates the vesicourethral anastomosis, thanks to the wristed instrumentation. In addition, all steps that affect functional results such as nerve-sparing, bladder neck sparing, leaving a long urethra can be performed more comfortably with the da Vinci robotic system.
Despite the many advantages that the da Vinci robotic system offers in addition to conventional laparoscopy, the most important limitation is the burden on the health care system, with an initial purchase price of ∼$ 1.2 million and an annual maintenance cost of $100,000. Lotan et al. reported a cost advantage of $1239/case with LRP over RALP. 10 Again, Bolenz et al. stated that RALP was the most expensive procedure, even without including the initial purchase and annual maintenance costs of the da Vinci robotic system. They reported that the inclusion of these costs incurred an additional cost of $2698/case. 11 Steinberg et al. concluded that RALP was not financially feasible in low-volume centers with less than 80 RP cases per year. 25 The approximate cost of 3D LRP is $150,000 without the cost of additional consumables. 12 Our aim to conduct this study was to investigate whether 3D LRP offers an experience closer to RALP at less cost, and in our experience, 3D LRP is somewhere between conventional LRP and RALP. To our knowledge, this study is the first prospective study comparing 3D LRP with RALP.
Studies have shown that 3D visualization makes it easier to acquire laparoscopic skills than 2D, it increases speed and reduces the number of performance errors.26–31 Cicione et al. reported that 3D imaging increases surgical performance in residents without laparoscopy training compared to experts. 32 Tanagho et al. found that simple and complex tasks were significantly shorter with 3D than with 2D. In addition, 87.9% of the participants preferred 3D and found no difference between the two imaging systems in terms of side effects. 30 Wagner et al. determined that simple tasks took 25%–30% longer time to complete, while more complex tasks took 75% longer time to complete with 2D than with 3D. 31 We are also of the opinion that the benefits of 3D imaging are more pronounced in complex procedures such as RP. Furthermore, carrying out laparoscopy training with 3D imaging may cause laparoscopy beginners to learn more easily and not be discouraged.
Studies comparing 3D LRP with conventional LRP have shown that 3D visualization provides significant advantages. Studies have shown that 3D LRP is associated with statistically significantly shorter operative time,6,12,13,33 vesicourethral anastomosis time,6,12,13,33 lower amount of bleeding, 12 higher rate of early continence,12,33 and better pentafecta rate at 12 months. 6 In their study comparing 3D LRP with conventional LRP, Kinoshita et al. interestingly found no statistically significant difference in vesicourethral anastomosis time between the two groups. However, in multivariate analysis, they determined that the experience of the surgeon and 3D imaging were independent predictors of shortening vesicourethral anastomosis time. 34 Early results of our study showed that RALP and 3D LRP had similar perioperative, short-term oncological, and functional outcomes other than operative time.
The place and use of the da Vinci robotic system in the health care system is a very important problem that needs to be solved. Although RALP offers a more comfortable operation to the surgeon compared to LRP, does it provide significant perioperative, oncological, and functional contributions to patients? A systematic review, including two randomized controlled studies, comparing RALP and LRP stated that RALP preserved erectile function and continence better than LRP. However, it was noted that given the insufficient number of randomized controlled studies and the varying quality of the available studies, there was no sufficient evidence to wholeheartedly support or refute the use of one technique over another. 35 Nossiter et al. also stated that although a better sexual function score was reported by men with RALP compared to LRP 18 months after the diagnosis, this difference was small and clinically insignificant. 36 Another problem is that can the integration of cheaper technologies such as 3D imaging system and laparoscopic robotized needle holders into conventional laparoscopy reduce the burden of RALP on the health care system by overcoming the long learning curve of LRP? We are of the opinion that 3D LRP can be an alternative to RALP, especially in low-volume centers. Another problem is the expectations of patients from the da Vinci robotic system. Schroeck et al. reported that patients who underwent RALP were more likely to feel regret and dissatisfaction, possibly because of an increased expectation of an “innovative” procedure. 37 It seems a reasonable approach to carefully explain the risks and benefits of all surgical techniques to patients to minimize patients' expectations.
Our study has the following limitations: (1) the small sample size, (2) the lack of randomization, (3) the short oncological and functional follow-up period, and (4) the surgeries were not performed by a single surgeon.
Conclusion
3D LRP has similar perioperative, short-term oncological, and functional outcomes to RALP, other than operative time. 3D LRP can offer a closer experience to RALP than conventional LRP with less cost than RALP. There is a need for prospective, randomized studies with larger populations evaluating long-term oncological and functional outcomes to reach more definitive conclusions.
Footnotes
Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.
