A Randomized Controlled Study of Robot-Assisted versus 3D Laparoscopic Radical Prostatectomy in Patients with Carcinoma Prostate

Materials and Methods A prospective randomized comparative study was performed from 1st January 2020 to 30th June 2021. All patients included were diagnosed with localized/locally advanced ca prostate. 60 patients fulfilling the inclusion and exclusion criteria were randomized into 2 groups. Groups A and B included patients who underwent robot-assisted radical prostatectomy and 3D laparoscopic transperitoneal radical prostatectomy, respectively. Various demographic, intraoperative, postoperative, and follow-up parameters were collected. Outcomes were evaluated in the form of the trifecta (continence, potency, and BCR-free status) and pentafecta rates (trifecta with no perioperative complications and negative surgical margins) in between the two groups. Results The mean operative time in Group A was 137.83 mins ± 17.27 compared to 148.20 mins ± 26.16 in Group B. Trifecta rates in Group A and Group B were 43.3%, 63.3%, and 76.6% and 40%, 53.3%, and 70% at 1, 3, and 6 months. Pentafecta rates in Group A and Group B were 36.6%, 53.3%, and 70% and 33.3%, 40%, and 53.3% at 1, 3, and 6 months. Complication rates were 10% in Group A and 13.3% in Group B, respectively. Only one patient in our study (Group B) had a positive surgical margin. Conclusions We conclude from our comparative study, that both robot-assisted and 3D laparoscopic transperitoneal radical prostatectomy are feasible and efficacious treatment modalities for achieving acceptable trifecta and pentafecta rates in managing ca prostate with earlier continence and shorter urethrovesical anastomosis time in the robotic arm.


Introduction
Prostate cancer is the most common urological malignancy in the world. Treatment for prostate cancer depends upon several factors, such as whether the malignancy is localized, locally advanced, or metastatic [1]. Laparoscopic and robotic approaches have largely taken over open radical prostatectomy in recent years [2]. With the 3-dimensional laparoscopy technology, new stereoscopic vision enables better depth perception resulting in faster and safer outcomes, especially with intracorporeal suturing in the form of urethravesical anastomosis [3,4]. However, laparoscopy has many limitations, and a steep learning curve is required for the surgeon. Tese shortcomings have led to the concept that robots may improve the precision and accuracy of anatomical dissection by ofering enhanced freedom and easy maneuverability, thereby improving overall outcomes.
Only a few studies directly compare LRP (laparoscopic radical prostatectomy) and RARP (robot-assisted radical prostatectomy) from a single institution. Tis is the frst Indian single-surgeon series reporting a prospective randomized comparison between 3D laparoscopic and robotassisted radical prostatectomy for prostatic carcinoma.

Materials and Methods
A total of 70 patients were evaluated in this prospective randomized comparative study, which was conducted at our institute from 1 January 2020 to 30 June 2021. 60 patients met the inclusion criteria. Patients were randomized into two groups using the computer-generated randomization table. Group A included patients who underwent robotassisted radical prostatectomy and Group B included patients on whom laparoscopic transperitoneal radical prostatectomy was performed. Patients (age ≤76 years) with a life expectancy of a minimum of 10 years [1] having localized or locally advanced cancer prostate were included. Patients with metastatic, T4 disease, having received radiotherapy or hormonal therapy for prostate cancer and having any comorbidity precluding general anesthesia and laparoscopic surgery were excluded. Various demographic, intraoperative, postoperative, and follow-up parameters were collected. Ethical approval was obtained from the ethics committee (IEC/VMMC/SJH/Tesis/2020-03/CC-06) (Figure 1 fow diagram).
Surgeries were performed by a single urologist having extensive laparoscopic and robotic experience in both the groups. Both 3D (Storz HD) lap and RARP (four-arm da Vinci Xi Robotic System) were carried out using a transperitoneal posterior antegrade approach with the assistant port on the right side ( Figure 2). Te robotic approach required one extra assistant port. Te urethrovesical anastomosis (UVA) was completed using continuous locking vicryl (V-Loc 3-0) ( Figure 3). Extended pelvic lymph node dissection was performed in all cases ( Figure 4). Pelvic drains were removed with a drain output of less than 30 ml/ day. Patients were discharged with per urethral catheter in situ. Catheter removal was performed after 10 days.
Outcomes were evaluated by comparing the trifecta (continence, potency and BCR-free status) and pentafecta rates (trifecta along with no perioperative complications and negative surgical margins) amongst the two groups. Complications were graded using the modifed Clavien−Dindo classifcation [5] with risk stratifcation via the D'Amico risk stratifcation system. Biochemical recurrence (BCR) was defned as two consecutive prostate-specifc antigen (PSA) levels of >0.2 ng/ ml. Functional outcomes were recorded at 1 month, 3 months, and 6 months after surgery. Continence was defned as the use of no pads in the past 1 month, while patients were able to achieve and maintain satisfactory erections for sexual intercourse in more than 50% of the attempts, with or without the use of PDE5 inhibitors, were considered potent. IIEF-5 questionnaire was used to compare the potency outcomes.
Te SPSS-PC-25 version was used for data and statistical analysis. Quantitative data were expressed in mean-± standard deviation, while qualitative data was represented in percentages. Student's t-test (unpaired) or MannWhitney U test was used to test the normality distribution diference. Te chi-square test or Fisher's exact test was used to test the statistical signifcance. P-value of less than 0.05 was considered statistically signifcant.

Results
A total of 60 patients were included and randomized into two groups. Demographic and perioperative comparisons are shown in Table 1. Te mean age in Group A was 58, and in Group B was 60 (p � 0.17). Te mean body mass index (BMI), blood investigations, PSA values, and median lobes were comparable in both the groups. Te mean prostate size on ultrasound in Group A was 52.0 cc, while in Group B, it was 42.90 cc (p � 0.01) and the diference was signifcant. Te mean Gleason's score on transrectal ultrasound (TRUS)    Te complication rate in Group A was 10%; two patients (6.67%) had minor complications (grades 1 and 2), and one patient (3.3%) had grade 3a (major) complication (Table 2).

. Discussion
With its increasing availability, robotic surgery is now becoming the more preferred treatment modality for surgical management of localized/locally advanced carcinoma prostate. Given the signifcantly higher economic burden  Advances in Urology associated with the procedure, it is only imperative that the perioperative, oncological, and functional parameters of RARP, LRP, or open surgery are genuinely compared. Te current 3D laparoscopic systems are comparable to the robotic surgical systems in terms of good depth perception and reduction of surgeon stress. Tey are also more economical and easy to maintain. However, LRP is a technically demanding procedure requiring advanced laparoscopic dissection and suturing skills with a steeper learning curve.
Robot-assisted laparoscopy is now the go-to modality given the 3D vision, thereby increasing the six degrees of freedom, allowing better dexterity with instruments, tremor flters, and an ergonomic surgical console to reduce the surgeon's fatigue [2]. Although claims of superior functional and oncologic outcomes of RARP compared with other approaches are common in the current literature, almost all available data are derived from prospective nonrandomized or retrospective studies that provide low evidence [2,[6][7][8][9].
Tis is the frst prospective randomized study comparing these two groups in terms of their outcomes. Te preoperative and demographic data were comparable in both the groups and is similar to the previous studies. Tere was no signifcant diference in the mean operative time in the two groups; however, the urethrovesical anastomosis time was shorter in Group A. Alenizi et al. [10] reports the mean UVA time of 20 mins for RARP, which is longer in comparison to our study. Bove et al. [11] reports the mean   Te continence rates in Group A were 73%, 83%, and 96% and in Group B were 46.7%, 70%, and 90% at 1, 3, and 6 months, respectively. Te p value for continence between the two groups was signifcant at 1 month. Tese results were comparable with the RCT published by Benelli et al. [14]. Tis may be due to the precise and meticulous dissection using robotic assistance around the neurovascular tissues with a shorter UVA time and a better preservation of the membranous urethral length. BCR-free rates at 1, 3, and 6 months were 100% in all visits for both the groups, which were higher than those of other comparable studies, but a longer follow-up is suggested to establish signifcance.
Pentafecta rates in Group A and Group B were 36.6%, 53.3%, and 70% and 33.3%, 40%, and 53.3% at 1, 3, and 6 months, respectively. Te 3 months pentafecta rates were comparable with Bove [13] LRP (45%); however, higher 6 months pentafecta rates were achieved in our study than those of other 3D LRP and RARP studies. Te previously reported complication rates postrobotic radical prostatectomy have been estimated to be around 10% [16], which is similar to those in our study. In a reverse systematic review performed by Moretti et al. [17], minimally invasive surgery, especially RARP, shows better perioperative and complication results, which are associated with less complex cases, higher annual surgeon volume, and improved performance.
Tis study has limitations. Te prospective nature of the study, the small sample size, and the short follow-up duration could afect the outcomes and alter decision-making. Multicenter randomized control trials with larger sample sizes and diverse study populations are recommended to validate our fndings.

Conclusion
In this single-surgeon comparative study, both the robotassisted and 3D laparoscopic transperitoneal radical prostatectomy are feasible and efcacious options in achieving acceptable pentafecta rates. RARP ofers a signifcant edge in terms of the urethrovesical anastomosis time and the return to early continence with precise safety margins and comparable complications with the laparoscopic approach.

Data Availability
Te data used to support the fndings of this study are available from the corresponding author upon request.

Conflicts of Interest
Te authors declare that they have no conficts of interest.