Publications by authors named "Stefano Puliatti"

80 Publications

Development and Validation of the Metric-Based Assessment of a Robotic Dissection Task on an Avian Model.

J Surg Res 2022 Apr 30;277:224-234. Epub 2022 Apr 30.

ORSI Academy, Melle, Belgium; Faculty of Life and Health Sciences, Ulster University, Derry, Northern Ireland, UK; Faculty of Medicine, KU Leuven, Leuven, Belgium.

Introduction: The introduction of robot-assisted surgical devices requires the application of objective performance metrics to verify performance levels.

Objective: To develop and validate (face, content, response process, and construct) the performance metrics for a robotic dissection task using a chicken model.

Methods: In a procedure characterization, we developed the performance metrics (i.e., procedure steps, errors, and critical errors) for a robotic dissection task, using a chicken model. In a modified Delphi panel, 14 experts from four European Union countries agreed on the steps, errors, and critical errors (CEs) of the task. Six experienced surgeons and eight novice urology surgeons performed the robotic dissection task twice on the chicken model. In the Delphi meeting, 100% consensus was reached on five procedure steps, 15 errors and two CEs. Novice surgeons took 20 min to complete the task on trial 1 and 14 min during trial two, whereas experts took 8.2 min and 6.5 min. On average, the Expert Group completed the task 56% faster than the Novice Group and made 46% fewer performance errors.

Results: Sensitivity and specificity for procedure errors and time were excellent to good (i.e., 1.0-0.91) but poor (i.e., 0.5) for step metrics. The mean interrater reliability for the assessments by two robotic surgeons was 0.91 (Expert Group inter-rater reliability = 0.92 and Novice Group = 0.9).

Conclusions: We report evidence which supports the demonstration of face, content, and construct validity for a standard and replicable basic robotic dissection task on the chicken model.
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http://dx.doi.org/10.1016/j.jss.2022.02.056DOI Listing
April 2022

Patient's perception of resident's quality of care delivery. A nationwide study.

BJU Int 2022 May 2. Epub 2022 May 2.

Department of Surgery, Urology Section, University of Catania, Catania, Italy.

Introduction: Patients' perceptions about residents could give important information both as feedback to improve the quality of the training itself and the quality of the medical assistance offered to patients in academic hospitals. We present the results of a nationwide survey among urological patients to evaluate their perception of resident's quality of care.

Methods: An anonymous survey was distributed to patients referring to 22 Italian academic Institutions. The survey investigates the professional figure of the resident in urologist perceived by the patient.

Results: A total of 2587 patients were enrolled in this study. The 51.6% of patients correctly identified the urology resident; however, almost 40% of responders discriminated residents from fully trained urologists based exclusively on their young age. Overall, 98.2% patients rated the service provided by the resident as at least sufficient. Urology trainees were considered to have good communication skills, expertise, and willingness by more than the 50% of the patients interviewed. Overall, the patients showed an excellent willingness to be managed by urology residents. In particular, the percentage of patients not available for this purpose showed an increasing trend directly correlated with the difficulty of the procedure. Around 5% to 10% of patients were not willing to be managed by residents for simple procedures such as clinical visit, cystoscopy, or sonography, up to a third is not ready to undergo any surgical procedure performed by residents during steps of major surgery, neither if the residents are adequately tutored.

Conclusions: Our data showed that patients have a good willingness to be managed by residents during their training, especially for medium-low difficulty procedures. Furthermore, the majority of patients interviewed rated sufficient the residents' care delivery. Urology trainees were considered to have good communication skills, expertise, and willingness.
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http://dx.doi.org/10.1111/bju.15768DOI Listing
May 2022

"Augmented reality" applications in urology: a systematic review.

Minerva Urol Nephrol 2022 Apr 6. Epub 2022 Apr 6.

Keck School of Medicine, Catherine and Joseph Aresty Department of Urology, USC Institute of Urology, Los Angeles, CA, USA -

Introduction: Augmented reality (AR) applied to surgical procedures refers to the superimposition of preoperative or intra-operative images onto the operative field. Augmented reality has been increasingly used in myriad surgical specialties including Urology. The following study reviews advances in the use of AR for improvements in urologic outcomes.

Evidence Acquisition: We identified all descriptive, validity, prospective randomized/nonrandomized trials and retrospective comparative/noncomparative studies about the use of AR in Urology up until March 2021. The MEDLINE, Scopus, and Web of Science databases were used for literature search. We conducted the study selection according to the PRISMA (Preferred Reporting Items for Systematic Reviews and meta-analysis statement) guidelines. We limited included studies to only those using AR, excluding all that used virtual reality technology.

Evidence Synthesis: A total of 60 studies were identified and included in the present analysis. Overall, 19 studies were descriptive/validity/phantom studies for specific AR methodologies, 4 studies were case reports, and 37 studies included clinical prospective/retrospective comparative studies.

Conclusions: Advances in AR have led to increasing registration accuracy as well as increased ability to identify anatomic landmarks and improve outcomes during Urologic procedures such as RARP and robot-assisted partial nephrectomy.
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http://dx.doi.org/10.23736/S2724-6051.22.04726-7DOI Listing
April 2022

Assessing pentafecta achievement after robot-assisted radical cystectomy and its association with surgical experience: Results from a high-volume institution.

Urol Oncol 2022 Jun 29;40(6):272.e11-272.e20. Epub 2022 Jan 29.

Department of Urology, OLV Hospital, Aalst, Belgium; ORSI Academy, Melle, Belgium.

Objectives: Radical cystectomy (RC) represents the gold standard treatment for high-risk bladder cancer. Despite evidence suggesting that surgical experience correlates with perioperative and oncologic outcomes of robot-assisted RC (RARC), validated tools to assess its quality objectively are lacking. We aimed to evaluate the impact of RC-Pentafecta (absence of early major complications, absence of urinary diversion related sequelae at ≤12 months, absence of soft tissue surgical margins, ≥16 lymph nodes at final pathology and absence of clinical recurrence at ≤12 months) on oncological outcomes and the role of surgical experience on its achievement.

Materials And Methods: We retrospectively evaluated 366 patients undergoing RARC with intracorporeal urinary diversion in a single tertiary centre with a minimum of 1 year follow-up. Surgeries were performed using the DaVinci Xi system according to a previously described technique. Kaplan-Meier curves were used to investigate 5-years overall survival and cancer specific mortality-free survival (CSS) according to RC-Pentafecta achievement. Multivariable Cox's regressions were performed to evaluate the impact of RC-Pentafecta on overall mortality. Multivariable logistic regressions were performed to explore the effect of surgical experience on RC-pentafecta achievement. Locally weighted scatterplot smoother function was used to graphically explore this relationship.

Results: Patients achieving RC-Pentafecta showed higher 5-year overall survival (71.8% vs. 59.6%, P < 0.001) and CSS (84% vs. 71%, P < 0.001) when compared with patients not achieving it. At multivariable Cox's regression, RC-Pentafecta achievement (HR 0.57, P = 0.03), positive surgical margins (HR 2.48, P = 0.002), pN+ (HR 2.23, P = 0.002), pT≥3 (HR 1.71, P = 0.04) and current smoking status (HR 2.4, P = 0.006) were significant predictors of overall mortality. At multivariable logistic regression surgical experience (OR 1.2, P < 0.001), age (OR 0.93, P = 0.04), previous prostate surgery (OR 0.7, P = 0.02) and pT≥3 (OR 0.8, P = 0.03) were independent predictors of RC-Pentafecta achievement. A linear relationship between surgical experience and RC-Pentafecta achievement, without reaching a plateau, was observed.

Conclusions: RC-Pentafecta is a valuable tool to assess surgical quality of RARC and the experience of the center where the surgery is performed and may be used to identify "referral" centers for treatment of high-risk bladder cancer.
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http://dx.doi.org/10.1016/j.urolonc.2022.01.001DOI Listing
June 2022

Does quality assured eLearning provide adequate preparation for robotic surgical skills; a prospective, randomized and multi-center study.

Int J Comput Assist Radiol Surg 2022 Mar 7;17(3):457-465. Epub 2022 Jan 7.

ORSI Academy, Melle, Belgium.

Purpose: In particular after the onset of the COVID-19 pandemic, there was a precipitous rush to implement virtual and online learning strategies in surgery and medicine. It is essential to understand whether this approach is sufficient and adequate to allow the development of robotic basic surgical skills. The main aim of the authors was to verify if the quality assured eLearning is sufficient to prepare individuals to perform a basic surgical robotic task.

Methods: A prospective, randomized and multi-center study was conducted in September 2020 in the ORSI Academy, International surgical robotic training center. Forty-seven participants, with no experience but a special interest in robotic surgery, were matched and randomized into four groups who underwent a didactic preparation with different formats before carrying out a robotic suturing and anastomosis task. Didactic preparation methods ranged from a complete eLearning path to peer-reviewed published manuscripts describing the suturing, knot tying and task assessment metrics.

Results: The primary outcome was the percentage of trainees who demonstrated the quantitatively defined proficiency benchmark after learning to complete an assisted but unaided robotic vesico-urethral anastomosis task. The quantitatively defined benchmark was based on the objectively assessed performance (i.e., procedure steps completed, errors and critical errors) of experienced robotic surgeons for a proficiency-based progression (PBP) training course. None of the trainees in this study demonstrated the proficiency benchmarks in completing the robotic surgery task.

Conclusions: PBP-based e-learning methodology is an effective training method avoiding critical errors in the suturing and knotting task. Quality assured online learning is insufficient preparation for robotic suturing and knot tying anastomosis skills.

Trial Registration: ClinicalTrials.gov Identifier: NCT04541615.
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http://dx.doi.org/10.1007/s11548-021-02545-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740863PMC
March 2022

Laparoscopic assisted mini-ECIRS for ectopic kidney lithiasis: A case report and literature review.

CEN Case Rep 2022 Jan 4. Epub 2022 Jan 4.

Department of Urology, University Hospitals Leuven, Leuven, Belgium.

Introduction: Ectopic kidney is a rare anatomic variant with an incidence of about 1 in 900. Renal stones can pose a challenge when a standard approach is not possible. Laparoscopic-assisted endourologic procedure can be a feasible and safe choice.

Case Report And Literature Review: We present a case of 32 years old man with spastic quadriplegia, megacolon and pelvic kidney undergoing intervention of laparoscopic-assisted Mini ECIRS for staghorn stone of the left pelvic kidney. To the best of our knowledge, only 59 cases are reported in the literature concerning laparoscopically assisted encdourologic treatment which seems a feasible, safe and adaptable technique in selected complex cases.

Conclusion: Laparoscopic-assisted mini ECIRS is a viable option for the treatment of ectopic kidney stones. This technique should be considered when anatomical anomalies are encountered, to avoid puncture-related complications.
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http://dx.doi.org/10.1007/s13730-021-00683-xDOI Listing
January 2022

Three-dimensional Model Reconstruction: The Need for Standardization to Drive Tailored Surgery.

Eur Urol 2022 02 30;81(2):129-131. Epub 2021 Nov 30.

Uro-technology and SoMe Working Group of the Young Academic Urologists, European Association of Urology, Arnhem, The Netherlands; ORSI Academy, Ghent, Belgium; Department of Urology, OLV Hospital Aalst, Aalst, Belgium.

The clinical utility of three-dimensional virtual models has been widely explored for preoperative planning, patient counseling, surgical training, and intraoperative navigation. There is now a need for standardized methodology for construction of these models so that their utility can be realized in routine practice to achieve the goal of individualized treatment for patients.
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http://dx.doi.org/10.1016/j.eururo.2021.11.010DOI Listing
February 2022

Simplified PADUA renal (SPARE) nephrometry score validation and long-term outcomes after robot-assisted partial nephrectomy.

Urol Oncol 2022 02 22;40(2):65.e1-65.e9. Epub 2021 Nov 22.

Department of Urology, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium; ORSI Academy, Melle, Belgium.

Background: International guidelines suggest the use of anatomic scores to predict surgical outcomes after partial nephrectomy (PN). We aimed at validating the use of Simplified PADUA Renal (SPARE) nephrometry score in robot-assisted PN (RAPN).

Materials And Methods: Three hundred and sixty-eight consecutive RAPN patients were included. Primary endpoints were overall complications, postoperative acute kidney injury (AKI) and TRIFECTA achievement. Secondary endpoint was estimated glomerular filtration rate (eGFR) decrease at last follow-up. Multivariable logistic and linear regression models were used.

Results: Of 368 patients, 229 (62%) vs. 116 (31%) vs. 23 (6.2%) harboured low- vs. intermediate- vs. high-risk renal mass, according to SPARE classification. SPARE score predicted higher risk of overall complications (Odds ratio [OR]: 1.23, 95%CI 1.09-1.39; P < 0.001), and postoperative AKI (OR: 1.20, 95%CI 1.08-1.35; P < 0.01). Moreover, SPARE score was associated with lower TRIFECTA achievement (OR: 0.89, 95%CI 0.81-0.98; P = 0.02). Predicted accuracy was 0.643, 0.614 and 0.613, respectively. After a median follow-up of 40 (IQR: 21-66) months, eGFR decrease ranged from -7% in low-risk to -17% in high-risk SPARE.

Conclusions: SPARE scoring system predicts surgical success in RAPN patients. Moreover, SPARE score is associated with eGFR decrease at long-term follow-up. Thus, the adoption of SPARE score to objectively assess tumor complexity prior to RAPN may be preferable.
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http://dx.doi.org/10.1016/j.urolonc.2021.09.021DOI Listing
February 2022

Concomitant robot-assisted laparoscopic surgeries for upper and lower urinary tract malignancies: a comprehensive literature review.

J Robot Surg 2021 Nov 8. Epub 2021 Nov 8.

Department of Urology, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.

Worldwide, we have witnessed an expansion of robot-assisted laparoscopic surgery (RALS) and thanks to the global adoption of high-resolution diagnostic imaging technologies, an increased incidence of newly diagnosed prostatic, renal and bladder cancers has been recorded with concurrent second primary urological cancer diagnoses increasing by 1.5%. Diverse authors have reported their findings concerning synchronous multi-visceral malignances robotic treatment within the scientific literature. The aim of this study is to comprehensively review all reported articles describing concurrent upper and lower RALS using a singular robotic port scheme within the same intervention for renal malignances and concomitant prostatic or bladder cancers. To the best of our knowledge and vigorous literature search, this is the first study that comprehensively evaluates and reports all combined upper and lower urinary tract surgeries published so far. In carefully selected patients, thanks to multidisciplinary preoperative assessment and surgical planning a combined robotic approach can reduce the morbidity, complications, hospital admissions and the overall length of hospitalization.
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http://dx.doi.org/10.1007/s11701-021-01317-1DOI Listing
November 2021

Robotic-assisted versus open simple prostatectomy: Results from a systematic review and meta-analysis of comparative studies.

Investig Clin Urol 2021 11;62(6):631-640

Department of Urology, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.

Purpose: To review safety and efficacy of robotic-assisted simple prostatectomy (RASP) compared to open simple prostatectomy (OP).

Materials And Methods: A comprehensive literature search was performed to assess the differences in perioperative course and functional outcomes in patients with benign prostatic hyperplasia and surgical indication. The incidences of complications were pooled using the Cochran-Mantel-Haenszel Method and expressed as odds ratio (OR), 95% confidence interval (CI), and p-values. Perioperative course and functional outcomes were pooled using the inverse variance of the mean difference (MD), 95% CI, and p-values. Analyses were two-tailed and the significance was set at p<0.05.

Results: Eight studies were accepted. Meta-analysis showed significantly longer surgical time (MD, 43.72; 95% CI, 30.57-56.88; p<0.00001) with a significantly lower estimated blood loss (MD, -563.20; 95% CI, -739.95 to -386.46; p<0.00001) and shorter postoperative stay (MD, -2.85; 95% CI, -3.72 to -1.99; p<0.00001) in RASP. Catheterization time did not differ (MD, 0.65; 95% CI, -2.17 to 3.48; p=0.65). The risk of blood transfusion was significantly higher in OP (OR, 0.23; 95% CI, 0.17-0.33; p<0.00001). The risk of recatheterization (OR, 1.96; 95% CI, 0.32-11.93; p=0.47), postoperative urinary infections (OR, 0.89; 95% CI, 0.23-3.51; p=0.87) and 30-day readmission rate (OR, 0.96; 95% CI, 0.61-1.51; p=0.86) did not differ. At 3-month follow-up, functional outcomes were similar.

Conclusions: RASP demonstrated a better perioperative outcome and equal early functional outcomes as compared to OP. These findings should be balanced against the longer operative time and higher cost of robotic surgery.
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http://dx.doi.org/10.4111/icu.20210297DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8566792PMC
November 2021

Early Catheter Removal on Postoperative Day 2 After Robot-assisted Radical Prostatectomy: Updated Real-life Experience with the Aalst Technique.

Eur Urol Focus 2021 Oct 19. Epub 2021 Oct 19.

Department of Urology, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium; ORSI Academy, Melle, Belgium.

We evaluated the feasibility and impact on short- and long-term functional outcomes of very early catheter removal on postoperative day (POD) 2 after robot-assisted radical prostatectomy (RARP). To the best of our knowledge, this is the first multisurgeon study with the largest cohort on very early (POD 2) catheter removal after RARP with follow-up of >1 yr. In 255/369 patients (69%) treated with RARP ± pelvic lymph node dissection, the catheter was removed on POD 2. Among the 255 patients, 33 (13%) required recatheterisation because of acute urinary retention after catheter removal. Of these 33 patients, five (2%) also experienced anastomotic leakage after catheter removal. The early (≤3 mo) urinary continence rate was 67% and the median time to urinary continence recovery was 1 mo. After median follow-up of 18 mo (interquartile range 13-24), 236 patients (88%) were continent. No anastomotic strictures occurred. Our observations confirm the feasibility and safety of POD 2 catheter removal after RARP and support its adoption for selected patients. PATIENT SUMMARY: After removal of the prostate for cancer, patients have a urinary catheter inserted. We investigated whether earlier removal of the catheter affects long-term urinary continence. The results show that it may be safe to remove the catheter on postoperative day 2 for selected patients.
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http://dx.doi.org/10.1016/j.euf.2021.10.003DOI Listing
October 2021

Psychological distress among patients awaiting histopathologic results after prostate biopsy: An unaddressed concern.

Urologia 2021 Oct 6:3915603211049889. Epub 2021 Oct 6.

Urology Department, University of Modena & Reggio Emilia, Modena, Italy.

Background: Prostate cancer is the most commonly diagnosed neoplasm in men. From the introduction of PSA testing, an increasing number of men undergoes prostate biopsy (PBX). While the physical side effects of PBx have been well investigated, its psychological impact has been under-evaluated.

Aim: The aim of our study is to investigate the presence of psychological distress (anxiety and depression) in patients waiting for histopathological results after prostate biopsy (PBx).

Methods: From February to April 2019, 51 consecutive patients undergoing prostate biopsies at our institution were included. Age, PSA, DRE, familiarity for prostate cancer, number of previous biopsies, type of anesthesia, number of cores were recorded. All patients filled the Hospital Anxiety and Depression Scale (HADS), a psychometric Likert-scale questionnaire, before receiving the histopathological results of their PBx.

Results: The prevalence of psychological distress among patients awaiting histopathologic results is 41% (21/51 patients), with anxiety being the main component of their distress. On multivariate analysis, PSA, family history, and repeat biopsy were significantly associated with anxiety and depression.

Conclusion: Patients undergoing PBx experience a burden of psychological distress waiting for histopathologic results, especially anxiety. Appropriate counseling should be offered to patients at high risk of developing psychological distress after PBx. Future goals would include technological improvements to shorten the time between biopsy and definitive results.
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http://dx.doi.org/10.1177/03915603211049889DOI Listing
October 2021

New Ultra-minimally Invasive Surgical Treatment for Benign Prostatic Hyperplasia: A Systematic Review and Analysis of Comparative Outcomes.

Eur Urol Open Sci 2021 Nov 22;33:28-41. Epub 2021 Sep 22.

Department of Oncology, Division of Urology, University of Turin, Turin, Italy.

Context: Benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS) is diagnosed in up to 80% of men during their lifetime. Several novel ultra-minimally invasive surgical treatments (uMISTs) for BPH/benign prostatic obstruction (BPO) have become available over the past 5 yr.

Objective: To evaluate the perioperative and functional outcomes of recently introduced uMISTs for BPH/BPO, including Urolift, Rezūm, temporary implantable nitinol device, prostatic artery embolization (PAE), and intraprostatic injection.

Evidence Acquisition: A systematic literature search was conducted in December 2020 using Medline (via PubMed), Embase (via Ovid), Scopus, and Web of Science (registered on PROSPERO as CRD42021225014). The search strategy used PICO criteria and article selection was conducted in accordance with the PRISMA guidelines. The risk of bias and the quality of the articles included were assessed. A dedicated data extraction form was used to collect the data of interest. Pooled and cumulative analyses were performed to compare perioperative and functional outcomes between study groups. A random-effects model using the DerSimonian and Laird method was used to evaluate heterogeneity. Stata version 15.0 software was used for all statistical analyses.

Evidence Synthesis: The initial electronic search identified 3978 papers, of which 48 ultimately met the inclusion criteria and were included in the analysis. Pooled analysis revealed a uMIST benefit in terms of International Prostate Symptom Score (IPSS; -9.81 points, 95% confidence interval [CI] -11.37 to -8.25 at 1 mo; -13.13 points, 95% CI -14.98 to -11.64 at 12 mo), maximum flow rate (from +3.66 ml/s, 95% CI 2.8-4.5 to +4.14 ml/s, 95% CI 0.72-7.56 at 12 mo), and postvoid residual volume (-10.10 ml, 95% CI -27.90 to 7.71 at 12 mo). No negative impact was observed on scores for the International Index of Erectile Function-5, Male Sexual Health Questionnaire-Ejaculatory Dysfunction bother and function scales (overall postintervention change in pooled median score of 1.88, 95% CI 1.34-2.42 at the start of follow-up; and 1.04, 95% CI 0.28-1.8 after 1 yr), or the IPSS-Quality of Life questionnaire.

Conclusions: Novel uMISTs can yield fast and effective relief of LUTS without affecting patient quality of life. Only Rezūm, UroLift, and PAE had a minimal impact on patients' sexual function with respect to baseline, especially regarding preservation of ejaculation.

Patient Summary: We reviewed outcomes for recently introduced ultra-minimally invasive surgical treatments for patients with lower urinary tract symptoms caused by benign prostate enlargement or obstruction. The evidence suggests that these novel techniques are beneficial in terms of controlling symptoms while preserving sexual function.

Take Home Message: Novel ultra-minimally invasive treatments can yield fast and effective relief of lower urinary tract symptoms without affecting a patient's quality of life.
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http://dx.doi.org/10.1016/j.euros.2021.08.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8473553PMC
November 2021

Potential Contenders for the Leadership in Robotic Surgery.

J Endourol 2022 03 26;36(3):317-326. Epub 2021 Oct 26.

ORSI Academy, Melle, Belgium.

To summarize the scientific published literature on new robotic surgical platforms with potential use in the urological field, reviewing their evolution from presentation until the present day. Our goal is to describe the current characteristics and possible prospects for these platforms. A nonsystematic search of the PubMed, Cochrane library's Central, EMBASE, MEDLINE, and Scopus databases was conducted to identify scientific literature about new robotic platforms other than the Da Vinci system, reviewing their evolution from inception until December 2020. Only English language publications were included. The following keywords were used: "new robotic platforms," "Revo-I robot," "Versius robot," and "Senhance robot." All relevant English-language original studies were analyzed by one author (R.F.) and summarized after discussion with an independent third party (E.M., S.Y., S.P., and M.A.). Since 1995, Intuitive Surgical, Inc., with the Da Vinci surgical system, is the leading company in the robotic surgical market. However, Revo-I, Versius, and Senhance are the other three platforms that recently appeared on the market with available articles published in peer-reviewed journals. Among these three new surgical systems, the Senhance robot has the most substantial scientific proof of its capacity to perform minimally invasive urological surgery and as such, it might become a contender of the Da Vinci robot. The Da Vinci surgical platform has allowed the diffusion of robotic surgery worldwide and showed the different advantages of this type of technique. However, its use has some drawbacks, especially its price. New robotic platforms characterized by unique features are under development. Of note, they might be less expensive compared with the Da Vinci robotic system. We found that these new platforms are still at the beginning of their technical and scientific validation. However, the Senhance robot is in a more advanced stage, with clinical studies supporting its full implementation.
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http://dx.doi.org/10.1089/end.2021.0321DOI Listing
March 2022

Development and validation of the metric-based assessment of a robotic vessel dissection, vessel loop positioning, clip applying and bipolar coagulation task on an avian model.

J Robot Surg 2021 Aug 12. Epub 2021 Aug 12.

ORSI Academy, Melle, Belgium.

The evolution of robotic technology and its diffusion does not seem to have been adequately accompanied by the development and implementation of surgeon training programs that ensure skilled and safe device use at the start of the learning curve. The objective of the study is to develop and validate performance metrics for vessel dissection, vessel loop positioning, clip applying and bipolar coagulation using an avian model. Three robotic surgeons and a behavioral scientist characterized the performance metrics of the task according to the proficiency-based progression methodology. Fourteen experienced robotic surgeons from different European countries participated in a modified online Delphi consensus. Eight experienced surgeons and eight novices performed the robotic task twice. In the Delphi meeting, 100% consensus was reached on the performance metrics. Novice surgeons took 26 min to complete the entire task on trial 1 and 20 min on trial 2. Experts took 10.1 min and 9.5 min. On average the Expert Group completed the task 137% faster than the Novice Group. The amount of time to reach the vessel part of the task was also calculated. Novice surgeons took 26 min on trial 1 and 20 min on trial 2. Experts took 5.5 min and 4.8 min. On average the experts reached the vessel 200% faster than the novices. The Expert Group made 155% fewer performance errors than the Novice Group. The mean IRR of video-recorded performance assessments for all metrics was 0.96 (95% confidence intervals (CI) lower = 0.94-upper = 0.98). We report the development and validation for a standard and replicable basic robotic vessel dissection, vessel loop positioning, clip applying and bipolar coagulation task on an avian model. The development of objective performance metrics, based on a transparent and fair methodology (i.e., PBP), is the first fundamental step toward quality assured training. This task developed on the avian model proved to have good results in the validation study.
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http://dx.doi.org/10.1007/s11701-021-01293-6DOI Listing
August 2021

The Unsolved Issue of Reporting of Late Complications in Urology.

Eur Urol 2021 11 3;80(5):527-528. Epub 2021 Aug 3.

Department of Urology, OLV Hospital, Aalst, Belgium; ORSI Academy, Melle, Belgium. Electronic address:

Lack of uniformity in the reporting of late complications hampers the quality of data available on surgical outcomes. Adoption of standardized criteria and a taxonomy for reporting of late complications is urgently needed.
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http://dx.doi.org/10.1016/j.eururo.2021.07.010DOI Listing
November 2021

The Use of Augmented Reality to Guide the Intraoperative Frozen Section During Robot-assisted Radical Prostatectomy.

Eur Urol 2021 10 29;80(4):480-488. Epub 2021 Jul 29.

Division of Urology, IRCCS Azienda Ospedaliero-Universitaria di Bologna; Università degli Studi di Bologna.

Background: Multiparametric magnetic resonance imaging (mpMRI) can guide the surgical plan during robot-assisted radical prostatectomy (RARP), and intraoperative frozen section (IFS) can facilitate real-time surgical margin assessment.

Objective: To assess a novel technique of IFS targeted to the index lesion by using augmented reality three-dimensional (AR-3D) models in patients scheduled for nerve-sparing RARP (NS-RARP).

Design, Setting, And Participants: Between March 2019 and July 2019, 20 consecutive prostate cancer patients underwent NS-RARP with IFS directed to the index lesion with the help of AR-3D models (study group). Control group consists of 20 patients matched with 1:1 propensity score for age, clinical stage, Prostate Imaging Reporting and Data System score v2, International Society of Urological Pathology grade, prostate volume, NS approach, and prostate-specific antigen in which RARP was performed by cognitive assessment of mpMRI.

Surgical Procedure: In the study group, an AR-3D model was superimposed to the surgical field to guide the surgical dissection. Tissue sampling for IFS was taken in the area in which the index lesion was projected by AR-3D guidance.

Measurements: Chi-square test, Student t test, and Mann-Whitney U test were used to compare, respectively, proportions, means, and medians between the two groups.

Results And Limitations: Patients in the AR-3D group had comparable preoperative characteristics and those undergoing the NS approach were referred to as the control group (all p ≥ 0.06). Overall, positive surgical margin (PSM) rates were comparable between the two groups; PSMs at the level of the index lesion were significantly lower in patients referred to AR-3D guided IFS to the index lesion (5%) than those in the control group (20%; p = 0.01).

Conclusions: The novel technique of AR-3D guidance for IFS analysis may allow for reducing PSMs at the level of the index lesion.

Patient Summary: Augmented reality three-dimensional guidance for intraoperative frozen section analysis during robot-assisted radical prostatectomy facilitates the real-time assessment of surgical margins and may reduce positive surgical margins at the index lesion.
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http://dx.doi.org/10.1016/j.eururo.2021.06.020DOI Listing
October 2021

Warm ischemia time length during on-clamp partial nephrectomy: does it really matter?

Minerva Urol Nephrol 2022 Apr 26;74(2):194-202. Epub 2021 Jul 26.

Department of Urology, Hospital S. Bassiano, Bassano del Grappa, Vicenza, Italy.

Background: The impact of warm ischemia time (WIT) on renal functional recovery remains controversial. We examined the length of WIT>30 min on the long-term renal function following on-clamp partial nephrectomy (PN).

Methods: Data from 23 centers for patients undergoing on-clamp PN between 2000 and 2018 were analyzed. We included patients with two kidneys, single tumor, cT1, minimum 1-year follow-up, and preoperative eGFR≥60 mL/min/1.73m. Patients were divided into two groups according to WIT length: group I "WIT≤30 min" and group II "WIT>30 min." A propensity-score matched analysis (1:1 match) was performed to eliminate potential confounding factors between groups. We compared eGFR values, eGFR (%) preservation, eGFR decline, events of chronic kidney disease (CKD) upgrading, and CKD-free progression rates between both groups. Cox regression analysis evaluated WIT impact on upgrading of CKD stages.

Results: The primary cohort consisted of 3526 patients: group I (N.=2868) and group II (N.=658). After matching the final cohort consisted of 344 patients in each group. At last follow-up, there were no significant differences in median eGFR values at 1, 3, 5, and 10 years (P>0.05) between the matched groups. In addition, the median eGFR (%) preservation and absolute eGFR change were similar (89% in group I vs. 87% in group II, P=0.638) and (-10 in group I vs. -11 in group II, P=0.577), respectively. The 5 years new-onset CKD-free progression rates were comparable in the non-matched groups (79% in group I vs. 81% in group II, log-rank, P=0.763) and the matched groups (78.8% in group I vs. 76.3% in group II, log-rank, P=0.905). Univariable Cox regression analysis showed that WIT>30 min was not a predictor of overall CKD upgrading (HR:0.953, 95%CI 0.829-1.094, P=0.764) nor upgrading into CKD stage ≥III (HR:0.972, 95%CI 0.805-1.173, P=0.764). Retrospective design is a limitation of our study.

Conclusions: Our analysis based on a large multicenter international cohort study suggests that WIT length during PN has no effect on the long-term renal function outcomes in patients having two kidneys and preoperative eGFR≥60 mL/min/1.73m.
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http://dx.doi.org/10.23736/S2724-6051.21.04466-9DOI Listing
April 2022

Toward autonomous robotic prostate biopsy: a pilot study.

Int J Comput Assist Radiol Surg 2021 Aug 5;16(8):1393-1401. Epub 2021 Jul 5.

Department of Computer Science, University of Verona, Verona, Italy.

Purpose: We present the validation of PROST, a robotic device for prostate biopsy. PROST is designed to minimize human error by introducing some autonomy in the execution of the key steps of the procedure, i.e., target selection, image fusion and needle positioning. The robot allows executing a targeted biopsy through ultrasound (US) guidance and fusion with magnetic resonance (MR) images, where the target was defined.

Methods: PROST is a parallel robot with 4 degrees of freedom (DOF) to orient the needle and 1 DOF to rotate the US probe. We reached a calibration error of less than 2 mm, computed as the difference between the needle positioning in robot coordinates and in the US image. The autonomy of the robot is given by the image analysis software, which employs deep learning techniques, the integrated image fusion algorithms and automatic computation of the needle trajectory. For safety reasons, the insertion of the needle is assigned to the doctor.

Results: System performance was evaluated in terms of positioning accuracy. Tests were performed on a 3D printed object with nine 2-mm spherical targets and on an anatomical commercial phantom that simulates human prostate with three lesions and the surrounding structures. The average accuracy reached in the laboratory experiments was [Formula: see text] in the first test and [Formula: see text] in the second test.

Conclusions: We introduced a first prototype of a prostate biopsy robot that has the potential to increase the detection of clinically significant prostate cancer and, by including some level of autonomy, to simplify the procedure, to reduce human errors and shorten training time. The use of a robot for the biopsy of the prostate will create the possibility to include also a treatment, such as focal ablation, to be delivered through the same system.
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http://dx.doi.org/10.1007/s11548-021-02437-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295108PMC
August 2021

The Click-On gamma probe, a second-generation tethered robotic gamma probe that improves dexterity and surgical decision-making.

Eur J Nucl Med Mol Imaging 2021 12 25;48(13):4142-4151. Epub 2021 May 25.

Interventional Molecular Imaging-Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.

Purpose: Decision-making and dexterity, features that become increasingly relevant in (robot-assisted) minimally invasive surgery, are considered key components in improving the surgical accuracy. Recently, DROP-IN gamma probes were introduced to facilitate radioguided robotic surgery. We now studied if robotic DROP-IN radioguidance can be further improved using tethered Click-On designs that integrate gamma detection onto the robotic instruments themselves.

Methods: Using computer-assisted drawing software, 3D printing and precision machining, we created a Click-On probe containing two press-fit connections and an additional grasping moiety for a ProGrasp instrument combined with fiducials that could be video tracked using the Firefly laparoscope. Using a dexterity phantom, the duration of the specific tasks and the path traveled could be compared between use of the Click-On or DROP-IN probe. To study the impact on surgical decision-making, we performed a blinded study, in porcine models, wherein surgeons had to identify a hidden Co-source using either palpation or Click-On radioguidance.

Results: When assembled onto a ProGrasp instrument, while preserving grasping function and rotational freedom, the fully functional prototype could be inserted through a 12-mm trocar. In dexterity assessments, the Click-On provided a 40% reduction in movements compared to the DROP-IN, which converted into a reduction in time, path length, and increase in straightness index. Radioguidance also improved decision-making; task-completion rate increased by 60%, procedural time was reduced, and movements became more focused.

Conclusion: The Click-On gamma probe provides a step toward full integration of radioguidance in minimal invasive surgery. The value of this concept was underlined by its impact on surgical dexterity and decision-making.
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http://dx.doi.org/10.1007/s00259-021-05387-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8566398PMC
December 2021

The microbiological profile of patients with Fournier's gangrene: A retrospective multi-institutional cohort study.

Urologia 2021 May 22:3915603211018441. Epub 2021 May 22.

Urology Unit, San Carlo di Nancy Hospital - GVM Care and Research, Rome, Italy.

Objectives: To evaluate the role of the microbiological profile and of disease-related factors in the management of patients affected with Fournier's gangrene (FG).

Patients And Methods: Data regarding patients admitted for FG at nine Italian Hospitals (March 2007-June 2018) were collected. Patients were stratified according to the number of microorganisms documented: Group A - one microorganism; Group B - two microorganisms; Group C - more than three microorganisms. Baseline blood tests, dedicated scoring systems, predisposing risk factors, disease's features, management and post-operative course were analyzed. UpSet technique for visualizing set intersections in a matrix layout and Cuzick's nonparametric test for trend across ordered groups were used.

Results: Eighty-one patients were available for the analysis: 18 included in Group A, 32 in Group B, 31 in Group C. The most common microorganism isolated was Escherichia coli. In Group B-C, Escherichia coli was often associated to Enterococcus faecalis, Pseudomonas aeruginosa, and Klebsiella pneumoniae. Statistically significant positive association was highlighted among the number of pathogens (Group A vs B vs C) and serum C-reactive Protein ( < 0.001), procalcitonin ( = 0.02) and creatinine ( = 0.03). Scoring systems were associated with the number of microorganisms detected ( < 0.02). A significant association between the number of microorganisms and the use of VAC therapy and need of a fecal diversion was found ( < 0.02). The number of microorganisms was positively associated with the length of stay (LOS) ( = 0.02). Ten weeks after initial debridement, wound closure was achieved in 11 (91.7%), 22 (84.6%) and 20 (80%) patients in Group A, B, and C, respectively, with no differences in overall survival.

Conclusion: Polymicrobial infections in FG are positively associated with inflammatory scores, the need for fecal diversion and the LOS. This results may help the counseling and the clinical management of this rare niche of patients.
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http://dx.doi.org/10.1177/03915603211018441DOI Listing
May 2021

Digital Frozen Sections with Fluorescence Confocal Microscopy During Robot-assisted Radical Prostatectomy: Surgical Technique.

Eur Urol 2021 Dec 6;80(6):724-729. Epub 2021 May 6.

Department of Urology, Ospedale Policlinico e Nuovo Ospedale Civile S. Agostino Estense Modena, University of Modena and Reggio Emilia, Modena, Italy.

Background: Robot-assisted radical prostatectomy (RARP) involves a tradeoff between oncological control and functional outcomes. Intraoperative control of surgical margins (SMs) may help in ensuring the safety of the dissection. Fluorescence confocal microscopy (FCM) is an effective method for interpretation of prostate tissue and provides digital images with an appearance similar to hematoxylin-eosin staining.

Objective: To describe an alternative technique to NeuroSAFE for intraoperative evaluation of neurovascular-adjacent margins shaved from ex vivo specimens using FCM analysis.

Design, Setting, And Participants: This was a prospective study of 24 patients undergoing RARP with intraoperative FCM control of margin status.

Surgical Procedure: After surgical dissection, SMs are sectioned from the fresh prostate using the Mohs technique (shaving): three slices from the apex and the right and left posterolateral aspects are obtained. Digital images of the shavings are immediately acquired via FCM and shared with a remote pathologist. In the case of a positive SM, a focal secondary resection of the bundle can be performed owing to the ability of FCM to locate a region of interest on the flat sample.

Measurements: The primary outcome measure was the rate of negative margins at neurovascular-adjacent sites. Oncological and functional outcomes for patients with 1 yr of follow-up are also reported.

Results And Limitations: All patients had negative SMs in shavings from neurovascular-adjacent areas at final histopathology; four underwent a secondary resection with final conversion to negative SM status. Nine of ten patients with 1-yr follow-up are free of biochemical recurrence (prostate-specific antigen persistence in one pN1 case), nine are fully continent, and four of the five with preoperative potency have recovered their sexual function.

Conclusions: Digital frozen sections with FCM during RARP may represent an alternative to NeuroSAFE for possible optimization of functional outcomes without compromising oncological safety.

Patient Summary: We developed a technique to ensure complete removal of cancer tissue during surgical removal of the prostate. Tissue specimens are examined via digital microscopy in real time during the operation. This allows the surgeon to remove more tissue if cancer is detected at the margins of a specimen, while avoiding unnecessary removal of healthy tissue.
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http://dx.doi.org/10.1016/j.eururo.2021.03.021DOI Listing
December 2021

Urinary frequency in COVID-19 patients.

Minerva Urol Nephrol 2022 02 22;74(1):122-124. Epub 2021 Apr 22.

Department of Urology, University of Modena and Reggio Emilia, Modena, Italy.

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http://dx.doi.org/10.23736/S2724-6051.21.04396-2DOI Listing
February 2022
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