Stesura Seveso Archivio Italiano di Urologia e Andrologia 2024; 96(3):12531 1 ORIGINAL PAPER approach, which allowed for nerve-sparing, that the pro- cedure gained popularity (4). The retropubic open approach was considered the gold standard for more than two decades, until about 25 years ago when the first laparoscopic radical prostatectomy was performed (5). Further innovations were to follow, and soon after, in 2002, the first reports of robot-assisted procedures start- ed to emerge (6). Since then, the surgical management of prostate cancer has changed drastically. Nevertheless, the uptake of robotic systems varies even today from country to country and mostly depends on cost, insurance cover- age, and government healthcare approval (7). Still, the market share of RARP is extremely high, with up to 85% in the USA and more than 92% in England (8), which does not leave much room for ORP. Considering the immense expansion of robotics in urology, justified ques- tions emerged: should this open surgical technique be performed at all in the robotics era? While RARP is gen- erally accepted to have a shorter hospital stay, there is conflicting evidence regarding functional outcomes and no reliable data on oncological outcomes (9) when the two techniques are compared. The main goal of this prospective study was to assess the safety, functional out- comes, and oncological outcomes after ORP and RARP performed by two experienced surgeons at one institu- tion. METHODS We prospectively analyzed the records of patients who underwent radical prostatectomy at our institution between August 2021 and July 2023. The ethics committee of the State Medical Chamber of Baden-Württemberg approved the project (F-2023-120). The data were obtained from the patient data manage- ment software (CGM Clinical®), in which all relevant data such as preoperative staging, external imaging findings, therapy-relevant parameters, and complication rates are prospectively updated. The main criterion for surgical technique selection was patient preference. Patients were informed about the available surgical options for their condition during their preoperative consultations with their respective referring urologists. During these consul- tations, patients were provided with comprehensive information about each surgical approach, including its benefits, risks, and potential outcomes. Patients were Introduction: To determine the very early functional as well as oncological outcomes after robot-assisted radical prostatectomy (RARP) and open rad- ical prostatectomy (ORP) at a single institution. Methods: We identified patients who underwent RARP or ORP at our institution between August 2021 and July 2023. The main criterion for surgical technique selection was patient preference. Primary endpoints included anastomosis leakage rate, very early continence rate reported by standardized pad-test, and positive surgical margin rate. Furthermore, we analyzed opera- tion time, hospital stay, postoperative analgesia, and complica- tion rates. Results: In this prospective study, we analyzed data from 222 radical prostatectomies (111 RARP and 111 ORP). There were no significant differences in preoperative age, prostate size, and risk stratification among the groups. Patients who underwent RARP had lower anastomosis leakage rates (8.1% vs. 18.9%) and slightly lower early continence rates (76.6% vs. 78.4%) when compared to patients who underwent ORP. Positive surgi- cal margin rates were similar, and complication rates were also comparable. Operation time was similar for both techniques, but the hospital stay was significantly shorter in the RARP group (6.3 vs. 9.1 days, p = 0.03). The ORP group experienced signifi- cantly higher opioid administration postoperatively (p < 0.001). Conclusions: From a functional and oncological point of view, both techniques are safe and provide excellent outcomes when performed by experienced surgeons. Nevertheless, patients are likely to benefit from a shortened hospital stay and reduced postoperative pain after RARP. KEY WORDS: Robot-assisted radical prostatectomy; Open radical prostatectomy; Functional outcomes; Oncological outcomes. Submitted 1 April 2024; Accepted 11 April 2024 INTRODUCTION Prostate cancer is a major health concern and represents the second most commonly diagnosed cancer in men, with an estimated 1.4 million new cases worldwide in 2020; incidence is mainly dependent on age (1). The main goal of radical prostatectomy by any approach is the eradication of cancer while, whenever possible, preserv- ing pelvic organ function (2). The initial transperineal open technique was described more than 100 years ago (3), but it was not until the '80s with the retropubic The impact of surgical technique on very early functional outcomes after radical prostatectomy Mladen Stankovic Department of Urology, Salem Hospital, Academic Hospital, University of Heidelberg, Heidelberg, Germany. DOI: 10.4081/aiua.2024.12531 Summary Archivio Italiano di Urologia e Andrologia 2024; 96(3):12531 M. Stankovic 2 encouraged to express their preferences based on their individual medical history, personal preferences, and understanding of the procedures. We obtained data from 263 patients but excluded 41 to standardize surgical vari- ables, resulting in a final cohort of 222 patients treated by two highly experienced surgeons, each having performed over 2000 procedures in representive technique. During ORP, the retropubic access was used, the endopelvic fas- cia was incised, and the prostate dissected in ascending order. The vesicourethral anastomosis was performed using six independent single sutures. During RARP, the transperitoneal approach was used, the endopelvic fascia was also incised, but the prostate was dissected in descending order. The vesicourethral anastomosis was performed using one running suture with two needles. Standard lymphadenectomy was performed using anatomical landmarks, regardless of the surgical approach. The catheter was removed directly after the cystography was performed (day 5-6 after RARP and day 7-8 after ORP) given no urinary leakage was evident. In case of leakage, the catheter remained for another 1-2 days, depending on the leakage severity. Upon catheter removal, patients had one day for pelvic floor muscle exercises, explained and taught by a physical therapist. The very early continence was then documented using a standardized pad test. This test measures the amount of involuntary urine loss while performing predefined phys- ical activities with a full bladder within 1h. The urine pad was weighed before and after the test. Full continence was defined as urine loss of 0-10g and one urine pad per day. Mild urinary incontinence grade I and grade II were defined as urine loss of 10-25 g and 25-50 g, respective- ly. Urine loss of > 50 g represented severe incontinence. The pathologist graded the tumors according to the Gleason system (10), analyzing the entire prostate includ- ing every tumor focus. The complication rates were doc- umented using the Clavien-Dindo classification (11). The statistics were performed using SPSS Software v23. The significance level was set at 0.05. RESULTS Between August 2021 and July 2023, 222 men with his- tologically proven prostate cancer underwent radical prostatectomy, of whom 111 underwent ORP and 111 underwent RARP. The main patient characteristics are list- ed in Table 1. There were no significant differences in pre- operative age, PSA, and IPSS between the RARP and ORP groups. Based on D’Amico's (12) risk classification of prostate cancer, 13 patients (11.7%) had intermediate- risk and 98 patients (88.3%) had high-risk cancer in the ORP group, as represented in Figure 1. In the RARP group, 6 patients (5.4%) and 105 patients (94.6%) had intermediate- and high-risk cancer, respectively. Figures 2 and 3 show the disease spread and Gleason score among the groups. Most of the patients had a pre- operative prostate volume of ≤ 70 ml on the transrectal ultrasound (RARP 84.6% vs. ORP 86.1%) as shown in Figure 4. Nerve sparing was able to be performed on 37.8% of patients in the RARP group and on 39.6% of patients in the ORP group. Pelvic lymph node dissection (PLND) was performed on all patients. The duration of Figure 1. D’Amico Risk stratification. Table 1. Patient characteristics. Variable RARP n, (%) ORP n, (%) p value Age (median, years) 69.9 70.3 0.24 pPSA (median, ng/ml) 7.2 7.7 0.66 IIEF 5 (median) 12.2 11.8 0.71 IPSS(median) 18.5 19.1 0.69 TRUS (median, cm3) 45.1 46.3 0.81 pT stage 0.16 pT2 69 (62.2) 79 (71.2) pT3a 29 (26.1) 21 (18.9) pT3b 13 (11.7) 11 (9.9) Nerve sparing 0.64 unilateral 19 (17.1) 18 (16.2) bilateral 23 (20.7) 26 (23.4) without 69 (62.2) 67 (60.4) Positive surgical margins 15 (13.6) 17 (15.3) 0.54 Clavien Dindo 0.74 n.a. 104 (93.7) 101 (91) 2 6 (5.4) 5 (4.5) 3a 1 (0.9) 3 (2.7) 3b n.a. 1 (0.9) 4 n.a. 1 (0.9) Gleason score 0.27 ≤ 7 96 (86.5) 89 (80.2) ≥ 8 15 (13.5) 22 (19.8) Lymph nodes removed (median) 16.1 15.4 0.36 Leakage at contrast cystography 9 (8.1) 21 (18.9) 0.59 Very early full continence rate 85 (76.6) 87 (78.4) 0.72 Operation time (median, minutes) 141.3 151.9 0.79 Hospital stay (median, days) 6.3 9.1 0.03 Epidural analgesia 1 (0.9) 81 (72.9) < 0.001 Overlapping opioids 1 (0.9) 72 (64.9) < 0.001 Patient-controlled analgesia pump 4 (3.6) 18 (16.2) < 0.001 Archivio Italiano di Urologia e Andrologia 2024; 96(3):12531 3 Functional outcomes after radical prostatectomy the procedure was similar among the groups, as were the positive surgical margin rates (13.6% RARP vs. 15.3% ORP). Patients who underwent RARP had lower anasto- mosis leakage rates (8.1% vs. 18.9%) and slightly lower early full continence rates (76.6% vs. 78.4%) when com- pared to patients who underwent ORP, though the differ- ences were not significant (Figure 5). Nevertheless, the hospital stay was significantly shorter in the RARP group (6.3 vs. 9.2 days, p = 0.03) and the ORP group experi- enced significantly higher opioid administration rates postoperatively (1 vs. 81 patients, p < 0.001). Finally, the complication rates were assessed and the vast majority of patients in both groups (93.7% for RARP and 91% for ORP) did not experience any deviation from the normal postoperative course. DISCUSSION Despite the paucity of data on anastomosis leakage rates following radical prostatectomy due to many institutions no longer performing contrast cystography, our depart- ment remains one of the few that continues this practice. Additionally, we have consistently employed a standard- ized pad test for the past two decades. This allows us to confidently present our radiologically obtained leakage Figure 2. Diasease spread. Figure 4. Distribution of prostate size among groups. Figure 3. Distribution of Gleason Score among groups. Figure 5. Early continence rates based on standardized Pad-Test. Archivio Italiano di Urologia e Andrologia 2024; 96(3):12531 M. Stankovic 4 results as a reliable measure. Contrary to a prominent meta-analysis suggesting superior early functional out- comes for RARP compared to ORP (13), our research did not corroborate this. We discovered no significant dis- crepancies regarding the early continence rate between the two procedures. Continence is typically evaluated 12 months post-surgery, with average late continence rates generally being around 80% (14, 15). However, our find- ings demonstrate exceptionally high early continence rates upon catheter removal of 76.6% for RARP and 78.4% for ORP (16). Furthermore, our severe early incontinence rates barely reached 6% for both tech- niques, markedly lower than the average 15% cited in existing literature (17, 18). Mirroring another meta-analy- sis (19), our study detected no significant divergence in positive surgical margin rates between the two tech- niques. Notably, surgical margin status is a crucial prog- nostic indicator for biochemical recurrence (20), and pos- itive surgical margin rates can fluctuate considerably, from 7% to 44%, depending on the surgeon's experience (21- 23). Regardless of factors such as patient and tumour characteristics and the size of lymph node packets removed, which influence the number of lymph nodes reported in histology (24, 25), our study found an insignificant difference in the number of lymph nodes removed per procedure (median 15.4 vs. 16.1; ORP vs. RARP). All patients underwent the same tissue processing and blocking procedures in the same laboratory. The dis- parity in preoperative prostate size, which can act as a predictive factor for functional outcomes, was not a con- cern as the majority of patients exhibited a preoperative prostate volume of ≤ 70 ml on transrectal ultrasound (RARP 84.6% vs. ORP 86.1%). Additionally, both proce- dures consumed similar operative time. Hospital stay was significantly shorter after RARP and ORP group experienced significantly higher opioid administration rates postoperatively, Our data showed that patients undergoing RARP had a significantly shorter hospital stay and fewer postoperative opioid requirements than the ORP group, proving the benefit of minimally invasive surgical approach, as already in literature reported (26). Nonetheless, the vast majority of patients in both groups did not experience any deviation from the normal postoperative course. We acknowledge that our study has its limitations. Single centre study with just two surgeons evaluated and lack of randomisation being some of them, so that the results might not generalise to other settings. Lack of intraoper- ative blood loss data and missing potency data being the other limitations. It should be mentioned that no patient required an intraoperative blood transfusion in either group. However, despite these limitations, our study has its strengths. We were able to prospectively analyse two almost identical patient groups who underwent two dif- ferent surgical techniques. Furthermore, in addition to minimising variability by having standardised proce- dures, we were also able to have somewhat of a surgeon heterogenity by having one expert in the respective surgi- cal approach, performing all the procedures. As some authors have already stated, the patients should be ancouraged to choose an experianced surgen rather that a specific surgical approach (27). Our study can be interpreted as a small contribution to a never ending-debate. CONCLUSIONS The two techniques yield very similar early functional and oncological outcomes when performed by very expe- rienced surgeons. ORP will probably continue to be per- formed in institutions with financial limitations and lim- ited access to robotics. Nevertheless, patients are likely to benefit from a shortened hospital stay and reduced post- operative pain after RARP. REFERENCES 1. 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