IDEAL-D Phase 0 Evaluation of the Avatera System in Robot-Assisted Prostate, Bladder and Renal Surgery.

Purpose: To evaluate the utilization of novel Avatera system in urological operations according to the IDEAL-D framework recommendations for high-risk invasive surgical devices. Materials and Methods: Three surgeons attempted to perform 23 upper and lower urinary tract operations on human cadavers and in live porcine models using the Avatera system. Total operative time and the duration of the substeps were evaluated. Surgical performance was assessed with the Global Evaluative Assessment of Robotic Skills (GEARS) score. Suturing was rated using the technical checklist for the assessment of suturing in robotic surgery. Attending surgeons rated their satisfaction with the Avatera system on a scale of 1-5. Results and Limitation: Seventeen out of 18 operations performed on cadavers were completed, while one pyeloplasty was discontinued. All five operations performed in porcine models were completed. Although 1 pig was euthanized on the fifth postoperative day, its symptoms were unrelated to surgery. Mean GEARS and Suturing scores in the upper urinary tract were 29 ± 0.7 and 29.5 ± 0.95, respectively, and in the lower urinary 28.5 ± 1.2 and 29.5 ± 0.5, respectively. Surgeons' satisfaction was high or very high for all procedures. Conclusions: The Avatera system was associated with good surgical performance and high surgeons' satisfaction rates. All urological procedures performed were shown to be feasible, with comparable risks to other robot-assisted surgery systems.

Assessment of different continence definitions in the context of the randomized multicenter prospective LAP-01 trial-Does the best definition change over time?

BACKGROUND: A uniform definition of continence is urgently needed to allow the comparison of study results and to estimate patient outcomes after radical prostatectomy (RP). To identify a practical definition that includes both objective and subjective aspects in a tangible way, we assessed different continence definitions and evaluated which best reflects the patients' subjective perception of continence. METHODS: Our analyses included 718 patients that underwent either robot-assisted radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) in a multicenter randomized patient-blinded trial. Continence was assessed through patient questionnaires prior to and at 3, 6 and 12 months after surgery which included the number of pads used per day, the ICIQ-SF and the question "Do you suffer from incontinence? (yes/no)" to assess subjective continence. We used Krippendorff's Alpha to calculate the agreement of different continence definitions with the subjective perception. RESULTS: At 3 months, the "0/safety pad" definition shows the highest agreement by alpha = 0.70 (vs. 0.63 for "0 pads" and 0.37 for "0-1 pad"). At 6 and 12 months "0 pads" is the better match, with alpha values of 0.69 (vs. 0.62 and 0.31) after 6 months and 0.70 (vs. 0.65 and 0.32) after 12 months. The ICIQ-SF score shows good correlation with the subjective continence at 3 months (alpha = - 0.79), the coefficient then decreasing to - 0.69 and - 0.59 at 6 and 12 months. CONCLUSION: The best continence definition according to the patients' perspective changes over time, "0 pads" being the superior criterion in the long-term. We recommend using the 0-pad definition for standardized continence reporting, as it is simple yet as accurate as possible given the inevitably high subjectivity of continence perception. Trial registration The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

Robot-assisted Versus Conventional Laparoscopic Radical Prostatectomy: A Systematic Review and Meta-analysis of Randomised Controlled Trials.

CONTEXT: Robot-assisted radical prostatectomy (RARP) has largely replaced conventional laparoscopic radical prostatectomy (LRP) even though the costs are significantly higher. Justification for this change is the hope for better postoperative functional results because of better dissection of the neurovascular bundle. OBJECTIVE: To perform a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing RARP and LRP for the primary outcome of continence (use of 0 pads or 1 safety pad) at 12 mo after surgery. EVIDENCE ACQUISITION: We searched the CENTRAL, MEDLINE, and Web of Science databases for RCTs comparing RARP versus LRP for adults with localised prostate cancer (PC). Where possible, individual-patient data were obtained. Secondary outcomes were potency for patients potent at baseline; a trifecta of patients continent and potent and no recurrence/further treatment; positive surgical margins; biochemical recurrence; and further treatment for PC. The systematic review was registered prospectively (reviewregistry1190 on www.researchregistry.com/). EVIDENCE SYNTHESIS: Five RCTs were identified. Three trial teams provided data. For another trial, only published data were available. The fifth trial was terminated prematurely because of insufficient recruitment and thus could not be included. Overall, data for 1205 randomised patients were available. At 12 mo, there was no significant difference between the two groups regarding continence (odds ratio [OR] 1.95, 95% confidence interval [CI] 0.67-5.62). However, at 3 mo and 6 mo there were significant differences in favour of RARP. Significantly more patients who were potent at baseline and underwent a robot-assisted nerve-sparing approach were potent at 12 mo (OR 4.05, 95% CI 1.63-10.09). CONCLUSION: At 12 mo after surgery there are no differences in continence between RARP and LRP. Short-term continence benefits of RARP were observed. Potent patients undergoing RARP consistently show better potency postoperatively. PATIENT SUMMARY: We analysed differences between robot-assisted removal of the prostate and conventional keyhole surgery for removal of the prostate. At 12 mo after surgery, there were no differences in continence outcomes between the two approaches. However, patients who were potent at baseline and underwent robot-assisted surgery were more likely to be potent at 12 mo.

Extended Pelvic Lymph Node Dissection Does Not Affect Functional Outcomes during Bilateral Nerve-Sparing Radical Prostatectomy.

INTRODUCTION: A possible association between extended pelvic lymph node dissection (ePLND) in radical prostatectomy (RPE) and functional outcomes such as erectile function (EF) and continence recovery has been previously considered. This association stems from the direct proximity of ePLND to the pelvic plexus. In this paper, we aimed to critically examine an association of ePLND with functional outcomes in patients who underwent bilateral nerve-sparing RPE. METHODS: 272 out of 782 patients from a randomized, patient-blinded, multicenter trial were retrospectively classified into two groups based on the D'Amico criteria: 114 had no PLND and 158 had ePLND. Continence (no pad/safety pad) and EF (Index of Erectile Function-5 [IIEF-5] questionnaire ≥17; sufficient erection for sexual intercourse) were assessed at 3, 6, and 12 months as well as postsurgical complications (Clavien-Dindo Classification). RESULTS: After 12 months of follow-up, no significant difference for potency could be found between men without and subjected to ePLND: IIEF-5 ≥17 (23.2% vs. 27.2%; p = 0.55) and sufficient erection for intercourse (44.1% vs. 45.6%; p = 0.84). A multiple linear regression analysis demonstrated that while preoperative EF (p < 0.001), pathological tumor stage (p = 0.027), and robot-assisted bilateral nerve-sparing RPE (p < 0.001) were independent predictors of EF recovery, the same did not apply to ePLND. No association was detected for continence recovery (94.2% vs. 89.7%; p = 0.22) and complications of any grade after surgery (11.4% vs. 16.5%; p = 0.24). CONCLUSION: ePLND is not associated with increased risk of erectile dysfunction, incontinence or complications after bilateral nerve-sparing RPE.

Quality of life after robotic-assisted and laparoscopic radical prostatectomy: Results of a multicenter randomized controlled trial (LAP-01).

BACKGROUND: To explore cross-sectional and longitudinal differences in general health-related and prostate cancer-specific quality of life (QoL) after robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy and to analyze predictive variables for QoL outcomes. METHODS: In this multicenter, randomized controlled trial, prostate cancer patients were randomly assigned 3:1 to undergo either RARP or LRP. Patient-reported outcomes were prospectively collected before and 1, 3, 6, 12 months after radical prostatectomy and included QoL as a secondary outcome. Validated questionnaires were used to assess general health-related (EORTC QLQ-C30) and prostate cancer-specific (QLQ-PR25) QoL. Cross-sectional and longitudinal contrasts were analyzed through linear mixed models. Predictive variables for QoL outcomes were identified by general linear modeling. RESULTS: Of 782 randomized patients, QoL was evaluable in 681 patients. In terms of general QoL, the cross-sectional analysis showed only small differences between study arms, whereas longitudinal comparison indicated an advantage of RARP on recovery: RARP patients reported an earlier return to baseline in global health status (3 vs. 6 months) and social functioning (6 vs. 12 months). In role functioning, only the RARP arm regained baseline scores. Regarding prostate-specific QoL, LRP patients experienced more urinary symptoms and reported 3.2 points (95% confidence interval 0.4-6, p = 0.024) higher mean scores at 1-month follow-up and in mean 2.9 points (0.1-5, p = 0.042) higher urinary symptoms scores at 3-month follow-up than RARP patients. There were no other significant differences between treatment groups. Urinary symptoms, sexual activity, and sexual function remained significantly worse compared with baseline at all time points in both arms. CONCLUSIONS: Compared with LRP, the robotic approach led to an earlier return to baseline in several domains of general health-related QoL and better short-term recovery of urinary symptoms. Predictive variables such as the scale-specific baseline status and bilateral nerve-sparing were confirmed.

Robotic-assisted Versus Laparoscopic Radical Prostatectomy: 12-month Outcomes of the Multicentre Randomised Controlled LAP-01 Trial.

BACKGROUND: Recently, our LAP-01 trial demonstrated superiority of robotic-assisted laparoscopic radical prostatectomy (RARP) over conventional laparoscopic radical prostatectomy (LRP) with respect to continence at 3 mo. OBJECTIVE: To compare the continence, potency, and oncological outcomes between RARP and LRP in the 12-mo follow-up. DESIGN, SETTING, AND PARTICIPANTS: In this multicentre, randomised, patient-blinded controlled trial, patients referred for radical prostatectomy to four hospitals in Germany were randomly assigned (3:1) to undergo either RARP or LRP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Continence was assessed as a patient-reported outcome through validated questionnaires. Secondary endpoints included potency and oncological outcomes. Data were statistically analysed by bivariate tests and multivariable models. RESULTS AND LIMITATIONS: At 12 mo, follow-up data were available for 701 of 782 patients. Continence at 6 and 12 mo after surgery was better in RARP patients, however no longer statistically significant (p = 0.068 and 0.38, respectively). Patients who were potent at baseline and underwent nerve-sparing surgery reported significantly higher potency after RARP, as defined by the capability to maintain an erection sufficient for intercourse at 3 (p = 0.005), 6 (p = 0.018), and 12 mo (p = 0.013). There were no statistically significant differences in oncological outcomes at 12 mo. It is a limitation that the influence of different anastomotic techniques was not investigated in this study. CONCLUSIONS: Both LRP and RARP offer a high standard of therapy for prostate cancer patients. However, robotic assistance offers better functional outcomes in specific areas such as potency and early continence in patients who are eligible for nerve-sparing RP. PATIENT SUMMARY: We compared outcomes 12 mo after radical prostatectomy between robotic-assisted and conventional laparoscopy. Both methods were equivalent with respect to oncological outcomes. Better recovery of continence in patients with robotic-assisted surgery, which was observed at 3 mo, blurred up to 12 mo. A benefit of robotic-assisted surgery was also observed in potency.

Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose?

OBJECTIVE: Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives. MATERIALS AND METHODS: LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads. RESULTS: 310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038). CONCLUSION: From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective. TRIAL REGISTRATION: The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01).

BACKGROUND: The LAP-01 trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy. OBJECTIVE: To compare the functional and oncological outcomes between RARP and LRP at 3 mo of follow-up. DESIGN, SETTING, AND PARTICIPANTS: In this multicentre, randomised, patient-blinded controlled trial, patients referred for radical prostatectomy to four hospitals in Germany were randomly assigned (3:1) to undergo either RARP or LRP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was time to continence recovery at 3 mo based on the patient's pad diary. Secondary outcomes included continence and potency as well as quality of life in addition to oncological outcomes for up to 3 yr of follow-up. Time to continence was analysed by log-rank test and depicted by the Kaplan-Meier method. Continuous measurements were analysed by means of linear mixed models. RESULTS AND LIMITATIONS: A total of 782 patients were randomised. The primary endpoint was evaluable in 718 patients (547 RARPs; full analysis set). At 3 mo, the difference in continence rates was 8.7% in favour of RARP (54% vs 46%, p = 0.027). RARP remained superior to LRP even after adjustment for the randomisation stratum nerve sparing and age >65 yr (hazard ratio = 1.40 [1.09-1.81], p = 0.008). A significant benefit in early potency recovery was also identified, while similar oncological and morbidity outcomes were documented. It is a limitation that the influence of different anastomotic techniques was not investigated in this study. CONCLUSIONS: RARP resulted in significantly better continence recovery at 3 mo. PATIENT SUMMARY: In this randomised trial, we looked at the outcomes following radical prostate surgery in a large German population. We conclude that patients undergoing robotic prostatectomy had better continence than those undergoing laparoscopic surgery when assessed at 3 mo following surgery. Age and the nerve-sparing technique further affected continence restoration.

Comparison of various continence definitions in a large group of patients undergoing radical prostatectomy: a multicentre, prospective study.

BACKGROUND: Due to the usage of various measurement methods and definitions, comparing continence rates after radical prostatectomy is a challenging task. This study compares continence rates based on different methods and aims to identify the definition for continence which agrees best with the patients' subjective assessment of continence. Additionally, continence was controlled for multiple influencing factors. METHODS: This prospective multicentre study was carried out in seven hospitals throughout Germany. Before and at 3, 6, and 12 months after surgery self-reporting questionnaires were completed and returned by 329 (84.4%) of 390 eligible patients. The questionnaires were independently evaluated and analysed by a third party. Association of continence with demographic, operative, and tumour factors in an ongoing comprehensive prostate cancer database was evaluated. RESULTS: The continence rate drops substantially for patients undergoing radical prostatectomy but increases again with time. Concrete numbers vary considerably depending on definition - 44% at 3 months and 68% at 12 months after surgery (0 pads) vs. 71 and 90% (0-1 pads). Significant confounding variables regarding continence rate are nerve-sparing procedure, categorized Gleason score, rehabilitative cure treatment, and pelvic floor training. The definition of 0 pads for continence coincides greater than 0-1 pads with the patients' self-assessment of being continent. CONCLUSION: A standardized definition for continence would be desirable, as it is one of the most important preconditions to guarantee sound comparison of continence rates. Since there are enough other factors that make comparison difficult, we suggest using the definition of "0 pads". It is easily measured objectively, leaves no room for interpretation, and agrees best with the patients' self-assessment.

Cancer-related fatigue in patients before and after radical prostatectomy. Results of a prospective multi-centre study.

PURPOSE: A multi-centre, longitudinal study was conducted to assess the prevalence of fatigue amongst men with localized prostate cancer, to describe several dimensions of fatigue and to explore the predictability of fatigue by psychological distress and physical function. METHODS: The prevalence of fatigue was evaluated using the Multidimensional Fatigue Inventory in 329 prostate cancer patients before, 3, 6 and 12 months after surgery. Psychological distress was assessed using the Hospital Anxiety and Depression Scale. Physical function was measured using the EORTC QLQ-C30. RESULTS: After surgery, about 14 % of the patients were screened with chronic fatigue. For all dimensions of fatigue, only small longitudinal changes could be observed. Psychological distress could be identified as a good predictor of fatigue after but not before surgery. CONCLUSIONS: Radical prostatectomy has no or little impact on the prevalence of fatigue. However, about 14 % of patients with chronic fatigue could possibly benefit from psychosomatic interventions. Interventions should consider the simultaneous appearance of fatigue and psychological distress and a reduced physical function.

Evaluating the learning curve of experienced laparoscopic surgeons in robot-assisted radical prostatectomy.

BACKGROUND AND PURPOSE: Radical prostatectomy is the gold standard surgical treatment for organ-confined prostate cancer. There is no consensus on the impact of previous laparoscopic experience on the learning curve of robot-assisted laparoscopic prostatectomy (RALP). We compared the perioperative complications and early patient outcomes from our initial 100 cases of RALP with laparoscopic prostatectomy (LRP) cases performed well beyond the learning curve. PATIENTS AND METHODS: Between July 2011 and January 2012, 110 RALP were performed by one of two surgeons, each with previous experience of more than 1000 LRP. The cases were pair matched from among the last 208 patients who had undergone LRP by the same surgeons at the same time. The clinical parameters, operative details, postoperative complications, and short-term outcomes from these patients, collected prospectively, were compared between the two groups. RESULTS: The prostate-specific antigen (PSA) level and age of the two groups was similar. The operative time (128.4 vs 153.9 min; P=0.01) and blood loss (200 vs 254 mL; P=0.01) was significantly less for the LRP group, but the duration of catheterization was similar (5.89 vs 6.2 days). The complication rate was low. No procedures needed conversions, and no patient had a visceral injury or blood transfusion. Twenty-three patients in the LRP group and 33 patients in the RALP group had extraprostatic disease, and the positive margin rate was 14% and 19% for these respective groups. At 3 months, PSA level was undetectable in 94% of LRP and 92% RALP patients, while 56% and 65% (P=0.062) patients in these groups were using 0 to 2 pads per day. CONCLUSIONS: The initial results of the outcome of RALP are at least at par with those of LRP and with those of previously published RALP series. This suggests the lack of a steep learning curve for experienced laparoscopic surgeons in performing RALP.

Early continence in patients with localized prostate cancer. A comparison between open retropubic (RRPE) and endoscopic extraperitoneal radical prostatectomy (EERPE).

OBJECTIVE: The study examined and compared continence rates in prostate cancer patients who had undergone either open retropubic prostatectomy (RRPE) or endoscopic extraperitoneal radical prostatectomy (EERPE). The core question was whether the surgical approach had an effect on the patients' continence status 3 months after surgery. METHODS: We conducted a multicentric, longitudinal study in 7 German hospitals. Three hundred fifty prostate cancer patients (166 EERPE, 184 RRPE) were asked to self-assess symptoms associated with urinary incontinence (UI) 1 day before and 3 months after prostatectomy. Symptoms of UI were assessed using the EORTC QLQ-PR25 questionnaire. Urinary continence was defined according to (1) the use of no protective pad, (2) the use of up to a single protective pad in a 24-hour period, and (3) according to the patient's self-assessment. A binary regression model was employed to predict early continence status. RESULTS: Three months after prostatectomy, 44% of patients who underwent EERPE and 40% of patients who underwent RRPE were completely continent. Patients who underwent nerve-sparing prostatectomy and patients younger than 65 years had a better chance of regaining urinary continence earlier. The surgical approach had no significant impact on the patients' continence status. Limitations of the study are a drop-out rate of 39% and sociodemographic and clinical differences between both treatment groups. CONCLUSIONS: Three months after prostatectomy, there were no significant differences between both treatment groups regarding urinary continence. The surgical approach had no significant effect on the patients' continence status. Higher age and non-nerve-sparing surgery are associated with a longer period of convalescence.

Comments on the extraperitoneal approach for standard laparoscopic radical prostatectomy: what is gained and what is lost.

Laparoscopic extraperitoneal radical prostatectomy (LERP) is considered the standard care treatment option for the management of localized and locally advanced prostatic cancer (PCa) in many institutes worldwide. In this work, the main advantages and disadvantages of LERP approach are reviewed with regard to its outcomes, the complication management, the learning curve, and the extend of pelvic lymph node dissection (PLND). It is concluded that LERP demonstrates comparable cancer control, urinary continence, and potency outcomes with the open and the robot-assisted radical prostatectomy, while offering advantages in complication management in comparison to the transperitoneal approach. Learning curve of LERP is considered long and stiff and significantly affects perioperative outcomes and morbidity, cancer control, and functional results. Thus, close mentoring especially in the beginning of the learning curve is advised. Finally, LERP still has a role in the limited or modified PLND offered in intermediate risk PCa patients.

[The assessment of therapy success after radical prostatectomy]. / Die Beurteilung des Behandlungserfolges nach Radikaler Prostatektomie.

OBJECTIVES: Patient satisfaction plays an important role in the outcome quality of treatment for localized prostate carcinoma. This paper identifies factors that impact patients' assessment of therapy success one year after surgery. METHODS: Patient assessment of therapy success was measured with the Hamburger Fragebogen zum Krankenhausaufenthalt (Lecher et al. 2002). Also, several sociodemographic, clinical and quality-of-life factors were tested for their impact on the patient assessment of therapy success. RESULTS: 25 % of patients gave a negative assessment of therapy success. Factors with the strongest impact were urinary incontinence, sexual impotence, younger age and higher risk of recidive. CONCLUSIONS: Especially the prevention of urinary continence and sexual dysfunction may lead to a better assessment of therapy. Moreover, the patients' expectations have a great impact on the assessment of therapy success.