Background
Post-prostatectomy urinary incontinence is an adverse event leading to significant distress. Our aim was to evaluate immediate urinary continence (UC) recovery in a single-surgeon ...prospective randomized comparative study between the traditional robot-assisted laparoscopic radical prostatectomy (TR-RALP) and the Retzius-sparing RALP (RS-RALP), for the treatment of the clinically localized prostate cancer (PCa).
Methods
102 consecutive PCa patients were prospectively randomized to TR-RALP (57) or RS-RALP (45). Postoperative continence was defined as patient-reported absence of leakage or use of 0 pads/day. The immediate continence rate and 95% confidence interval (CI 95%) were calculated for each treatment. Univariable and multivariate logistic regressions were used to assess predictors of immediate continence following RALP. Continence rates from 1 to 6 months were calculated by Kaplan–Meier curves; log-rank test was used for the curve comparison. Two analyses were performed, considering a per-protocol (PP) population regarding all randomized patients that received nerve-sparing RALP and an Intention-To-Treat (ITT) population regarding all randomized patients that received RALP.
Results
In the PP analysis, the rates of immediate continence were 12/40 (30%) (CI 95% 17–47%) for the TR-RALP and 20/39 (51.3%) (CI 95% 35–68%) for the RS-RALP (
p
= 0.05). In the ITT analysis, the corresponding rates were 12/57 (21%) (CI 95% 11–34%) for the TR-RALP and 23/45 (51%) (CI 95% 36–66%) for the RS-RALP (
p
= 0.001). Median time to continence was 21 days for the TR-RALP and 1 day for RS-RALP, respectively (
p
= 0.02). The relative Kaplan–Meier curves regarding continence resulted statistically different when compared with the log rank test (
p
= 0.02). In the multivariate analysis, lower age and the Retzius-sparing approach were significantly associated to earlier continence recovery.
Conclusions
The Retzius-sparing approach significantly reduces time to continence following RALP. Further studies are required to confirm the reproducibility of our results and investigate the role of the RS-RALP as an additional “protective” factor for postoperative continence in the elderly population.
Background
Identifying predictors of positive surgical margins (PSM) and biochemical recurrence (BCR) after radical prostatectomy (RP) may assist clinicians in formulating prognosis. Aim of the study ...was to report the midterm oncologic outcomes, to identify the risk factors for PSM and BCR and assess the impact of the PSM on BCR-free survival following robot-assisted laparoscopic radical prostatectomy (RALP).
Methods
From 2005 to 2010, 1679 consecutive patients underwent transperitoneal RALP. Data was retrospectively collected by an independent statistical company and analyzed in 2014. Median postoperative follow-up was 33.5 mo. BCR was defined as any detectable serum prostate-specific antigen (PSA) ≥ 0.2 ng/mL in two consecutive measurements. BCR-free survival was estimated using the Kaplan–Meier method. Univariate and multivariate analysis were applied to identify risk factors for PSM and BCR.
Results
In pN0/pNx cancers, pathologic stage was pT2 in 1186 patients (71.8%), pT3 in 455 patients (27.6%), and pT4 in 11 patients (0.6%). PSM rate was 17.4% and 36.9% of pT2 and pT3 cancers, respectively. Pathologic Gleason score was < 7, = 7 and > 7 in 42.1%, 53% and 4.9% of the patients, respectively. Overall BCR-free survival was 73.1% at 5 years; the 5-year BCR-free survival was 87.9% for pT2 with negative surgical margins. PSA, Gleason score (both bioptic and pathologic), pathologic stage (pT) and surgeon's volume were significant independent predictors of PSM. PSA, pathologic Gleason score, pT and PSM were significant independent predictors of BCR-free survival. Seminal vesicle-sparing, nerve-sparing approach and the extent of nerve-sparing (intra vs interfascial dissection) did not negatively affect margin status or BCR rates.
Conclusions
PSMs are a predictor of BCR. Being the only modifiable factor influencing the PSM rate, surgical experience is confirmed as a key factor for high-quality oncologic outcomes.
Purpose
To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).
Methods
302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN ...(CLOCK trial—ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.
Results
Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm,
p
< 0.001) and RENAL score (5 vs 6,
p
< 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml,
p
= 0.7), post-operative complications rate (19% vs 26%,
p
= 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%,
p
= 0.9; transfusion rate 3.4% vs 6.3%,
p
= 0.5; re-intervention due to bleeding 1.1% vs 4%,
p
= 0.4), acute kidney injury (4% vs 6%,
p
= 0.8), and positive surgical margins (3.5% vs 8.2%,
p
= 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09–0.52,
p
= 0.008).
Conclusions
The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.
The prostatic urethra (PU) is conventionally resected during robot-assisted radical prostatectomy (RALP). Recent studies demonstrated the feasibility of the extended PU preservation (EPUP).
To ...describe the histologic features of the PU.
The PU was evaluated using cystoprostatectomy and RALP specimens. Cases of PU infiltration by prostate cancer or distortion by benign hyperplastic nodules were excluded. The thickness of the chorion and distance between the urothelium and prostate glands were measured. Prostate-specific antigen expression in the PU epithelium was evaluated with immunohistochemistry. Descriptive statistics were used.
Six specimens of PU were examined. Histologically, the following layers of the PU were observed: (1) urothelium with basal membrane, (2) chorion, and (3) prostatic peri-urethral fibromuscular tissue. The chorion measures between 0.2 and 0.4 mm. There is not a distinct urethral muscle layer, but rather muscular fibers that originate near the prostatic stroma and are distributed around the PU. This muscular tissue appears to be mainly represented in the basal and apical urethra, but not in the middle urethra. The mean distance between the chorion and prostatic glands is 1.74 mm, with significant differences between base of the prostate, middle urethral portion, and apex (2.5 vs. 1.49 vs. 1.23 mm, respectively). PSA-expressing cells are abundant in the PU epithelium, coexisting with urothelial cells.
The exiguity of thickness of the PU chorion, short distance from glandular tissue, and coexistence of PSA-expressing cells in the epithelium raise important concerns about the oncologic safety of EPUP.
Lack of randomized controlled trials (RCTs) that compare pure laparoscopic radical prostatectomy (LRP) with robot-assisted laparoscopic radical prostatectomy (RALRP) is an important gap of the ...literature related to the surgical treatment of the clinically localized prostate cancer (PCa).
To provide the first prospective randomized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinically localized PCa.
Between 2007 and 2008, 128 consecutive male patients were randomized in two groups and treated by a single experienced surgeon with traditional LRP (Group I-64 patients) or RALRP (Group II-64 patients) in all cases with intent of bilateral intrafascial nerve sparing.
Primary end point was to compare the 12 months erectile function (EF) outcomes. Complication rates, continence outcomes, and oncological results were also compared. The sample size of our study was able, with an adequate power (1-beta>0.90), to recognize as significant large differences (above 0.30) between incidence proportions of considered outcomes.
No statistically significant differences were observed for operating time, estimated blood loss, transfusion rate, complications, rates of positive surgical margins, rates of biochemical recurrence, continence, and time to continence. However, the 12-month evaluation of capability for intercourse (with or without phosphodiesterase type 5 inhibitors) showed a clear and significant advantage of RALRP (32% vs. 77%, P<0.0001). Time to capability for intercourse was significantly shorter for RALRP. Rates of return to baseline International Index of Erectile Function (IIEF-6) EF domain score questionnaires (questions 1–5 and 15) (25% vs. 58%) and to IIEF-6>17 (38% vs. 63%) were also significantly higher for RALRP (P=0.0002 and P=0.008, respectively).
Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure. Larger RCTs are needed to confirm if a new gold-standard treatment in the field of RP has risen. Asimakopoulos AD, Pereira Fraga CT, Annino F, Pasqualetti P, Calado AA, and Mugnier C. Randomized comparison between laparoscopic and robot-assisted nerve-sparing radical prostatectomy.
Herein, we provide a systematic review and critical analysis of the current evidence on the applications of near-infrared fluorescence in robotic urologic surgery. Article selection proceeded ...according to Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. Overall, 14 studies were identified and included. Indocyanine green fluorescence imaging system has been tested for several applications, robotic partial nephrectomy representing the most studied one. Available evidence suggests this technology can be of aid in visually defining the surgical anatomy, thus ultimately facilitating the task of the console surgeon. Whether the added cost is justified by better outcomes remains to be determined.
For a given type of ileal neobladder, no standard length of ileum should be harvested; instead, the length should be tailored to the width of the ileum for a given patient. Clinical studies are ...required to confirm our model.
The capacity of a given shape of an orthotopic ileal neobladder (ONB) varies significantly, although the same length of preterminal ileum is utilised.
To investigate the variability of the human ileal width and to create a mathematical formula that calculates its impact on the neobladder capacity.
Design, setting, and participants: During 50 consecutive cases of robotic pelvic surgery, a segment of preterminal ileum was identified and the width was measured. A mathematical formula was created to calculate, for a given ileal length and width, the neobladder capacity and, for a given ileal width and neobladder capacity, the length of the (pre)terminal ileum to harvest. The accuracy of our model was tested on 28 pouches created by swine ileum.
Outcome measurements and statistical analysis: The interindividual variability of the ileal width and its impact on the ileal neobladder capacity was investigated.
The mean hemicircumference of the human distal ileum is 2.43 ± 0.39 cm (range 2–3.5 cm). According to our geometric model and as confirmed in the swine model, an increase of 1 cm in ileal width increases the neobladder capacity by 85%. The Pearson correlation coefficient reported a strong positive relationship between the formula-calculated and effective volumes of the pouch (r = 0.97). Moreover, for the same target capacity, 1 cm of difference in the ileal width implies harvesting 20 cm less ileum. A lack of testing on humans and application only to spheroidal neobladders are the main limits.
The ileal width impacts the capacity of the ONB. For a given type of ONB, no standard length of ileum should be harvested; instead, the length should be tailored to the width of the ileum for a given patient. Clinical studies are required to confirm our model.
We demonstrated the variability of the ileal width among humans, and we provided a mathematical formula tested on swine that evaluates the impact of the ileal width on the capacity of the orthotopic ileal neobladder.
Purpose
There is currently no consensus regarding the optimal treatment strategy for patients presenting with synchronous bilateral renal masses. The decision to perform bilateral procedures on the ...same intervention or in staged procedures is debated. The aim of this manuscript is to analyse the outcomes of simultaneous robot-assisted partial nephrectomy (RAPN) in a series of patients with bilateral renal masses treated at five Italian robotic institutions.
Methods
Data from a prospectively maintained multi-institutional database on patients subjected to simultaneous RAPN between November 2011 and July 2019 were reviewed. RAPNs were performed with da Vinci Si or Xi surgical system by expert robotic surgeons. Baseline demographics and clinical features, peri- and post-operative data were collected.
Results
Overall, 27 patients underwent simultaneous bilateral RAPN, and 54 RAPNs were performed without need of conversion; median operative time was 250 minutes, median estimated blood loss was 200 mL. Renal artery clamping was needed for 27 (50%) RAPNs with a median warm ischemia time of 15 minutes and no case of acute kidney injury. Complications were reported in 7 (25.9%) patients, mainly represented by Clavien 2 events (6 blood transfusions). Positive surgical margins were assessed in 2 (3.7%) of the renal cell carcinoma. At the median follow-up of 30 months, recurrence-free survival was 100%.
Conclusion
Our data showed that, in selected patients and expert hands, simultaneous bilateral RAPNs could be a safe and feasible procedure with promising results for the treatment of bilateral synchronous renal masses.