Orthotopic Robot-assisted Kidney Transplantation: Surgical Technique and Preliminary Results.

BACKGROUND AND OBJECTIVE: Orthotopic kidney transplantation (KT) has been proposed as an option for patients ineligible for heterotopic KT. In this scenario, orthotopic robot-assisted KT (oRAKT) represents a novel, minimally invasive alternative to the open approach. Here we describe the largest oRAKT series of patients, with a focus on the surgical technique, perioperative surgical outcomes, and functional results. METHODS: We queried prospectively maintained databases from three referral centers to identify patients who underwent oRAKT and evaluated surgical and functional outcomes. KEY FINDINGS AND LIMITATIONS: Overall, 16 oRAKT procedures were performed between January 2020 and August 2023. These involved four donors after cardiovascular death, five donors after brain death, and seven living donors. All oRAKT procedures were carried out in the left renal fossa. The indication for oRAKT was extensive calcification of the external iliac vessels (100%), frequently associated with prior KT (31%). The median operative time was 295 min (interquartile range [IQR] 268-360) and the median rewarming time 48 min (IQR 40-54). Conversion to open surgery occurred in two cases (12%), and delayed graft function was observed in two cases (12%). Postoperative complications occurred in 11 patients (69%) and three (18%) experienced Clavien-Dindo grade >II complications. At median follow-up of 9 mo (IQR 7-17), 14 patients had a functioning graft and median creatinine of 1.49 mg/dl (IQR 1.36-1.72). CONCLUSIONS AND CLINICAL IMPLICATIONS: Although oRAKT is a challenging procedure, it represents a feasible option for individuals ineligible for heterotopic KT and yields favorable perioperative and mid-term functional outcomes. PATIENT SUMMARY: We evaluated outcomes of orthotopic robot-assisted kidney transplantation (KT), in which the native kidney is removed and the donor kidney is transplanted into its place, in patients who are not eligible for heterotopic KT, in which the native kidney is left in place and the donor kidney is transplanted into a new location. We found that robot-assisted surgery is a safe and feasible alternative to traditional open surgery for orthotopic KT.

Robotic kidney transplantation.

Kidney transplantation is the best treatment option for patients with end-stage renal disease owing to improved survival and quality of life compared with dialysis. The surgical approach to kidney transplantation has been somewhat stagnant in the past 50 years, with the open approach being the only available option. In this scenario, evidence of reduced surgery-related morbidity after the introduction of robotics into several surgical fields has induced surgeons to consider robot-assisted kidney transplantation (RAKT) as an alternative approach to these fragile and immunocompromised patients. Since 2014, when the RAKT technique was standardized thanks to the pioneering collaboration between the Vattikuti Urology Institute and the Medanta hospital (Vattikuti Urology Institute-Medanta), several centres worldwide implemented RAKT programmes, providing interesting results regarding the safety and feasibility of this procedure. However, RAKT is still considered an alternative procedure to be offered mainly in the living donor setting, owing to various possible drawbacks such as prolonged rewarming time, demanding learning curve, and difficulties in carrying out this procedure in challenging scenarios (such as patients with obesity, severe atherosclerosis of the iliac vessels, deceased donor setting, or paediatric recipients). Nevertheless, the refinement of robotic platforms through the implementation of novel technologies as well as the encouraging results from multicentre collaborations under the umbrella of the European Association of Urology Robotic Urology Section are currently expanding the boundaries of RAKT, making this surgical procedure a real alternative to the open approach.

Robot-assisted radical cystectomy and ileal conduit with Hugo™ RAS system: feasibility, setting and perioperative outcomes

ABSTRACT Introduction: Robotic approach has shown its feasibility and safety with respect to open approach for radical cystectomy (1). The performances of Hugo™ RAS system (Medtronic, Minneapolis, USA) have been demonstrated in several clinical scenarios (2-5). We report the feasibility and surgical settings of the first series of robot-assisted radical cystectomy (RARC) with intracorporeal ileal-conduit performed with Hugo™ RAS system. Methods: Two patients were submitted to RARC with ileal conduit at our institution. The trocar placement scheme and the operating room setting with docking angles of the four arms were already described (6). A 12-mm and a 5-mm trocar for the assistant were placed. In both cases, an ileal-conduit with a Wallace type-1 uretero-enteric derivation was performed intra-corporeally. Results: The first patient was a 71-year-old male with a very-high risk non-muscle invasive bladder cancer(BC), and the second patient was a 64-year-old male with a diagnosis of T2 high-grade BC. Operative times were 360 and 420 minutes with a docking time of 12 and 9 minutes, respectively. No intraoperative complications occurred. The estimated blood loss was 200ml and 400ml, respectively. The second patient developed an ileus on postoperative day 4 (Clavien-Dindo grade 2). No positive surgical margins were recorded. No recurrence nor progression occurred during follow-up. Conclusion: RARC with intracorporeal ileal conduit urinary diversion is feasible with Hugo™ RAS system. We provided insight into the surgical setting using this novel robotic platform to help new adopters to face this challenging procedure. These findings may help a wider distribution of robotic programs for BC treatment.

Robot-assisted oncologic pelvic surgery with Hugo™ robot-assisted surgery system: A single-center experience.

Objective: To report the outcomes of intra- and extra-peritoneal robot-assisted radical prostatectomy (RARP) and robot-assisted radical cystectomy (RARC) with Hugo™ robot-assisted surgery (RAS) system (Medtronic, Minneapolis, MN, USA). Methods: Data of twenty patients who underwent RARP and one RARC at our institution between February 2022 and January 2023 were reported. The primary endpoint of the study was to report the surgical setting of Hugo™ RAS system to perform RARP and RARC. The secondary endpoint was to assess the feasibility of RARP and RARC with this novel robotic platform and report the outcomes. Results: Seventeen patients underwent RARP with a transperitoneal approach, and three with an extraperitoneal approach; and one patient underwent RARC with intracorporeal ileal conduit. No intraoperative complications occurred. Median docking and console time were 12 (interquartile range [IQR] 7-16) min and 185 (IQR 177-192) min for transperitoneal RARP, 15 (IQR 12-17) min and 170 (IQR 162-185) min for extraperitoneal RARP. No intraoperative complications occurred. One patient submitted to extraperitoneal RARP had a urinary tract infection in the postoperative period that required an antibiotic treatment (Clavien-Dindo Grade 2). In case of transperitoneal RARP, two minor complications occurred (one pelvic hematoma and one urinary tract infection; both Clavien-Dindo Grade 2). Conclusion: Hugo™ RAS system is a novel promising robotic platform that allows to perform major oncological pelvic surgery. We showed the feasibility of RARP both intra- and extra-peritoneally and RARC with intracorporeal ileal conduit with this novel platform.

The importance of second-look ureteroscopy implementation in the conservative management of upper tract urothelial carcinoma.

PURPOSE: The purpose of the study was to evaluate the effect of second-look ureteroscopy (SU) in the endoscopic operative work-up of patients with upper tract urothelial carcinoma (UTUC). MATERIALS AND METHODS: Patients with UTUC who underwent SU between 2016 and 2021 were included. Cancer detection rate (CDR) at SU was defined as endoscopic visualization of tumor. The effect of SU on recurrence-free survival (RFS), radical nephroureterectomy-free survival (RNU-FS), bladder cancer-free survival (BC-FS), and cancer-specific survival (CSS) was estimated using the Kaplan-Meier method. Multivariate logistic regression analysis (MLR) assessed predictors of negative SU. Finally, we evaluated the effect of SU timing on oncological outcomes, classifying SUs as "early" (≤ 8 weeks) and "late" (> 8 weeks). RESULTS: Overall, 85 patients underwent SU. The CDR at SU was 44.7%. After a median follow-up was 35 (IQR: 15-56) months, patients with positive SU had a higher rate of UTUC recurrence (47.4% vs 19.1%, p = 0.01) and were more frequently radically treated (34.2% vs 8.5%, p = 0.007). Patients with high-grade disease (hazard ratio [HR]: 3.14, 95% CI 1.18-8.31; p = 0.02) had a higher risk of UTUC recurrence, while high-grade tumor (HR: 3.87, 95%CI 1.08-13.77; p = 0.04) and positive SU (HR: 4.56, 95%CI 1.05-22.81; p = 0.04) were both predictors of RNU. Low-grade tumors [odds ratio (OR): 5.26, 95%CI 1.81-17.07, p = 0.003] and tumor dimension < 20 mm (OR: 5.69, 95%CI 1.48-28.31, p = 0.01) were predictors of negative SU. Finally, no significant difference emerged regarding UTUC recurrence, RNU, BC-FS, and CSM between early vs. late SUs (all p > 0.05). CONCLUSIONS: SU may help in identifying patients with UTUC experiencing an early recurrence after conservative treatment. Patients with low-grade and small tumors are those in which SU could be safely postponed after 8 weeks.

A new machine-learning model to predict long-term renal function impairment after minimally invasive partial nephrectomy: the Fundació Puigvert predictive model.

PURPOSE: To provide a new model to predict long-term renal function impairment after partial nephrectomy (PN). METHODS: Data of consecutive patients who underwent minimally invasive PN from 2005 to 2022 were analyzed. A minimum of 12 months of follow-up was required. We relied on a machine-learning algorithm, namely classification and regression tree (CART), to identify the predictors and associated clusters of chronic kidney disease (CKD) stage migration during follow-up. RESULTS: 568 patients underwent minimally invasive PN at our center. A total of 381 patients met our inclusion criteria. The median follow-up was 69 (IQR 38-99) months. A total of 103 (27%) patients experienced CKD stage migration at last follow-up. Progression of CKD stage after surgery, ACCI and baseline CKD stage were selected as the most informative risk factors to predict CKD progression, leading to the creation of four clusters. The progression of CKD stage rates for cluster #1 (no progression of CKD stage after surgery, baseline CKD stage 1-2, ACCI 1-4), #2 (no progression of CKD stage after surgery, baseline CKD stage 1-2, ACCI ≥ 5), #3 (no progression of CKD stage after surgery and baseline CKD stage 3-4-5) and #4 (progression of CKD stage after surgery) were 6.9%, 28.2%, 37.1%, and 69.6%, respectively. The c-index of the model was 0.75. CONCLUSION: We developed a new model to predict long-term renal function impairment after PN where the perioperative loss of renal function plays a pivotal role to predict lack of functional recovery. This model could help identify patients in whom functional follow-up should be intensified to minimize possible worsening factors of renal function.

Is There an Impact of Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted Biopsy in Clinically Significant Prostate Cancer Detection Rate? A Systematic Review and Meta-analysis.

CONTEXT: It is unclear whether a magnetic resonance imaging (MRI)-targeted transperineal (TP) biopsy can improve the detection of clinically significant prostate cancer (csPCa). OBJECTIVE: To compare the MRI-targeted TP and transrectal (TR) approaches for csPCa detection. EVIDENCE ACQUISITION: A literature search was conducted using the PubMed/Medline, Embase, and Web of Science databases to identify reports published until February 2023. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were followed to identify eligible studies. The primary outcome was the detection of csPCa (Gleason grade group ≥2). Sensitivity analyses were performed to investigate csPCa detection rates according to tumor location, Prostate Imaging Reporting and Data System (PI-RADS) score, and type of fusion (cognitive or software based). EVIDENCE SYNTHESIS: Eleven studies met our inclusion criteria, and data from 3522 and 5140 patients who underwent, respectively, TR and TP MRI-targeted biopsies were reviewed. No statistically significant difference in the detection of csPCa was observed between the TR and TP approaches (odds ratio [OR] 1.11, 95% confidence interval [CI] 0.98-1.25; p = 0.1). When stratifying patients according to lesion location, the TP approach was associated with higher csPCa detection in case of anterior (OR 2.17, 95% CI 1.46-3.22; p < 0.001) and apical (OR 1.86, 95% CI 1.14-3.03; p = 0.01) lesions. In the subgroup analysis based on PI-RADS score, the TP approach was associated with higher csPCa detection (OR 1.57, 95% CI 1.07-2.29; p = 0.02) in PI-RADS 4 lesions. Conversely, no difference was found in PI-RADS 3 and 5 lesions (p > 0.05). The main limitation was the retrospective design of most included studies. CONCLUSIONS: No significant association was found between the prostate biopsy approach and csPCa detection rate when we considered all biopsy indications. The TP approach provides a detection advantage in anterior and apical tumors, arguing for a preferred use of the TP approach in these lesion locations. PATIENT SUMMARY: The transperineal magnetic resonance imaging-targeted prostate biopsy approach appears to be more effective only for selected lesions. No clear benefit was seen for the transperineal approach in the overall population.

Robot-assisted radical cystectomy and ileal conduit with HugoTM RAS system: feasibility, setting and perioperative outcomes.

INTRODUCTION: Robotic approach has shown its feasibility and safety with respect to open approach for radical cystectomy (1). The performances of HugoTM RAS system (Medtronic, Minneapolis, USA) have been demonstrated in several clinical scenarios (2-5). We report the feasibility and surgical settings of the first series of robot-assisted radical cystectomy (RARC) with intracorporeal ileal-conduit performed with HugoTM RAS system. METHODS: Two patients were submitted to RARC with ileal conduit at our institution. The trocar placement scheme and the operating room setting with docking angles of the four arms were already described (6). A 12-mm and a 5-mm trocar for the assistant were placed. In both cases, an ileal-conduit with a Wallace type-1 uretero-enteric derivation was performed intra-corporeally. RESULTS: The first patient was a 71-year-old male with a very-high risk non-muscle invasive bladder cancer(BC), and the second patient was a 64-year-old male with a diagnosis of T2 high-grade BC. Operative times were 360 and 420 minutes with a docking time of 12 and 9 minutes, respectively. No intraoperative complications occurred. The estimated blood loss was 200ml and 400ml, respectively. The second patient developed an ileus on postoperative day 4 (Clavien-Dindo grade 2). No positive surgical margins were recorded. No recurrence nor progression occurred during follow-up. CONCLUSION: RARC with intracorporeal ileal conduit urinary diversion is feasible with HugoTM RAS system. We provided insight into the surgical setting using this novel robotic platform to help new adopters to face this challenging procedure. These findings may help a wider distribution of robotic programs for BC treatment.

Long-Term Oncologic Outcomes of Endoscopic Management of High-Risk Upper Tract Urothelial Carcinoma: The Fundació Puigvert's Experience.

Objectives: Many patients with upper tract urothelial carcinoma (UTUC) outside of the low-risk criteria may possess low absolute risks of distant progression. Herein, we hypothesized that careful selection of high-risk patients undergoing an endoscopic approach could result in acceptable oncologic outcomes. Materials and Methods: Patients with high-risk UTUC managed endoscopically between 2015 and 2021 were retrospectively identified from a prospectively maintained single academic institution database. Elective and imperative indications for endoscopic treatment were considered. Regarding elective indications, the decision to perform endoscopic treatment was systematically proposed to high-risk patients in whom macroscopically complete ablation was deemed feasible, excluding invasive appearance on CT scan, and without histologic variant. Results: A total of 60 patients with high-risk UTUC met our inclusion criteria (29 imperative and 31 elective indications). The median follow-up in patients without any event was 36 months. At 5 years, the estimated overall survival, cancer-specific survival, metastasis-free survival, UTUC recurrence-free survival, radical nephroureterectomy-free survival, and bladder recurrence-free survival were 57% (41-79), 75% (57-99), 86% (71-100), 56% (40-76), 81% (70-93), and 69% (54-88), respectively. All oncologic outcomes were similar between patients with elective and imperative indications (all log-rank p > 0.05). Conclusions: In conclusion, we report the first large series of endoscopic treatment in patients with high-risk UTUC, arguing that promising oncologic outcomes can be achieved in properly selected candidates. We encourage multi-institutional collaborative work as a large cohort of high-risk patients treated endoscopically may allow subgroup analyses to define the best candidates.

Sequential Treatment With Bacillus Calmette-Güerin (BCG) and Mitomycin C Administered With Electromotive Drug Administration (EMDA) in Patients With High-Risk Nonmuscle Invasive Bladder Cancer After BCG Failure.

BACKGROUND: Nowadays, there is no standard non-surgical treatment for patients with nonmuscle invasive bladder cancer (NMIBC) in whom Bacillus Calmette-Güerin (BCG) therapy has failed. OBJECTIVES: To assess the clinical and oncological outcomes of sequential treatment with Bacillus Calmette-Guerin (BCG) and Mitomycin C (MMC) administered with Electromotive Drug Administration (EMDA) in patients with high-risk NMIBC who fail BCG immunotherapy. MATERIAL AND METHODS: We retrospectively studied patients with NMIBC who failed BCG and received alternating BCG and Mitomycin C with EMDA between 2010 and 2020. Treatment schedule consisted in an induction therapy with 6 instillations (BCG, BCG, MMC + EMDA, BCG, BCG, MMC + EMDA) and a 1-year maintenance. Complete response (CR) was defined as the absence of high-grade (HG) recurrences during follow-up, and progression was defined as the occurrence of muscle invasive or metastatic disease. CR rate was estimated at 3, 6, 12, and 24 months. Progression rate and toxicity were also assessed. RESULTS: Twenty-two patients were included with a median age of 73 years. Fifty percent of tumors were single, 90% were smaller than 1.5cm, 40% were GII (HG) and 40% were Ta. CR rate was 95.5%, 81% and 70% at 3 and 6 months, 12 months and 24 months, respectively. With a median follow-up of 28.8 months, 6 patients (27%) presented HG recurrence and only 1 patient (4.5%) progressed and ended in cystectomy. This patient died due to metastatic disease. Treatment was well tolerated and 22% of the patients presented adverse effects, being dysuria the most frequent one. CONCLUSION: Sequential treatment with BCG and Mitomycin C with EMDA achieved good responses and low toxicity in selected patients who did not respond to BCG. Only 1 patient ended in cystectomy and died due to metastatic disease, therefore, cystectomy was avoided in most cases.

Initial experience of robot-assisted partial nephrectomy with Hugo™ RAS system: implications for surgical setting.

PURPOSE: Hugo™ RAS system is one of the most promising new robotic platforms introduced in the field of urology. To date, no data have been provided on robot-assisted partial nephrectomy (RAPN) performed with Hugo™ RAS system. The aim of the study is to describe the setting and report the performance of the first series of RAPN performed with Hugo™ RAS system. METHODS: Ten consecutive patients who underwent RAPN at our Institution between February and December 2022 were prospectively enrolled. All RAPN were performed transperitoneally with a modular four-arm configuration. The main outcome was to describe the operative room setting, trocar placement and the performance of this novel robotic platform. Pre, intra and post-operative, variables were recorded. A descriptive analysis was performed. RESULTS: Seven patients underwent RAPN for right-side and three for left-side masses. Median tumor size and PADUA score were 3 (2.2-3.7) cm and 9 (8-9), respectively. Median docking and console time were 9.5 (9-14) and 138 (124-162) minutes, respectively. Median warm ischemia time was 13 (10-14) minutes, and one case was performed clamp-less. Median estimated blood loss was 90 (75-100) mL. One major complication (Clavien-Dindo 3a) occurred. No case of positive surgical margin was recorded. CONCLUSION: This is the first series to prove the feasibility of Hugo™ RAS system in the setting of RAPN. These preliminary results may help new adopters of this surgical platform to identify critical steps of robotic surgery with this platform and explore solutions before in-vivo surgery.

Epidemiology, Diagnosis and Management of Penile Cancer: Results from the Spanish National Registry of Penile Cancer.

INTRODUCTION: Penile cancer (PC) is a rare malignancy with an overall incidence in Europe of 1/100,000 males/year. In Europe, few studies report the epidemiology, risk factors, clinical presentation, and treatment of PC. The aim of this study is to present an updated outlook on the aforementioned factors of PC in Spain. MATERIALS AND METHODS: A multicentric, retrospective, observational epidemiological study was designed, and patients with a new diagnosis of PC in 2015 were included. Patients were anonymously identified from the Register of Specialized Care Activity of the Ministry of Health of Spain. All Spanish hospitals recruiting patients in 2015 were invited to participate in the present study. We have followed a descriptive narration of the observed data. Continuous and categorical data were reported by median (p25th-p75th range) and absolute and relative frequencies, respectively. The incidence map shows differences between Spanish regions. RESULTS: The incidence of PC in Spain in 2015 was 2.55/100,000 males per year. A total of 586 patients were identified, and 228 patients from 61 hospitals were included in the analysis. A total of 54/61 (88.5%) centers reported ≤ 5 new cases. The patients accessed the urologist for visually-assessed penile lesions (60.5%), mainly localized in the glans (63.6%). Local hygiene, smoking habits, sexual habits, HPV exposure, and history of penile lesions were reported in 48.2%, 59.6%, 25%, 13.2%, and 69.7%. HPV-positive lesions were 18.1% (28.6% HPV-16). The majority of PC was squamous carcinoma (95.2%). PC was ≥cT2 in 45.2% (103/228) cases. At final pathology, PC was ≥pT2 in 51% of patients and ≥pN1 in 17% of cases. The most common local treatment was partial penectomy (46.9% cases). A total of 47/55 (85.5%) inguinal lymphadenectomies were open. Patients with ≥pN1 disease were treated with chemotherapy in 12/39 (40.8%) of cases. CONCLUSIONS: PC incidence is relatively high in Spain compared to other European countries. The risk factors for PC are usually misreported. The diagnosis and management of PC are suboptimal, encouraging the identification of referral centers for PC management.

Implementing a Checklist for Transurethral Resection of Bladder Tumor to Standardize Outcome Reporting: When High-quality Resection Could Influence Oncological Outcomes.

Several randomized controlled trials (RCTs) comparing en bloc resection of bladder tumor (ERBT) to conventional transurethral resection of bladder tumor (cTURBT) have reported controversial results. In particular, the 1-yr recurrence rate ranged from 5% to 40% for ERBT and from 11% to 31% for cTURBT. We provide an updated analysis of an RCT comparing the 1-yr recurrence rate for ERBT versus cTURBT for a cohort of 219 patients comprising 123 (56.2%) in the ERBT group and 96 (43.8%) in the cTURBT group. At 1 yr, 11 patients in the ERBT group and 12 in the cTURBT group experienced recurrence. The heterogeneity in recurrence observed in other RCTs could be explained by the scarce and heterogeneous adoption of tools and techniques that have been proved to lower the recurrence rate, supporting the need for implementation of a TURBT checklist. This prompted us to create a checklist of items for RCTs to standardize how TURBT is performed in trials, facilitate comparison between studies, assess the applicability of results in real-life practice, and provide a push towards high-quality resections to improve oncological outcomes. The checklist could have utility as a user-friendly guide for reporting TURBT procedures to improve our understanding of trials involving this procedure. Patient summary: We compared the recurrence rate at 1 year for bladder cancer treated with two different approaches to remove bladder tumors in our center. The rates were comparable for the two groups. Other studies have found widely differing recurrence rates, so we propose use of a checklist to standardize these procedures and provide more consistent outcomes for patients.

Energy source comparison in en-bloc resection of bladder tumors: subanalysis of a single-center prospective randomized study.

PURPOSE: Different energy sources are employed to perform en-bloc transurethral resection of bladder tumor (ERBT). No study compared different energy sources in ERBT. The aim is to compare the different ERBT sources in terms of pathological, surgical and postoperative outcomes. METHODS: This is a sub-analysis of a prospective randomized trial enrolling patients submitted to ERBT vs conventional TURBT from 03/2018 to 06/2021 (NCT04712201). 180 patients enrolled in ERBT group were randomized 1:1:1 to receive monopolar (m-ERBT), bipolar (b-ERBT) or thulium laser (l-ERBT). Endpoints were the comparison between energies in term of pathological analysis, intra, and post-operative outcomes. RESULTS: 49 (35%) m-ERBT, 45 (32.1%) b-ERBT, and 46 (32.9%) l-ERBT were included in final analysis. The rate of detrusor muscle (DM) presence was comparable between the energies used (p = 0.796) or the location of the lesion (p = 0.662). Five (10.2%), 10 (22.2%) and 0 cases of obturator nerve reflex (ONR) were recorded in m-ERBT, b-ERBT and I-ERBT groups, respectively (p = 0.001). Conversion to conventional TURBT was higher for lesions located in the anterior wall/dome/neck (p < 0.001), irrespective from the energy used. The presence of artifact in the pathological specimen was higher for lesions at the posterior wall (p = 0.03) and trigone (p = 0.03). CONCLUSIONS: In our study, no difference in staging feasibility among energies was found. Laser energy might be beneficial in lateral wall lesions to avoid ONR. Since there is an increased risk of ERBT conversion to conventional TURBT for lesions of the anterior wall, electrocautery might be preferred over laser to avoid waste of material.

The DEpth of Endoscopic Perforation scale to assess intraoperative perforations during transurethral resection of bladder tumor: subgroup analysis of a randomized controlled trial.

PURPOSE: Bladder perforation (BP) is the most important intraoperative adverse event of transurethral resection of bladder tumor (TURBT). It is frequently underreported despite its impact on the postoperative course. There is no standardized classification of BP. The study aims to develop a classification of the depth of endoscopic bladder perforation during TURBT. METHODS: This is a sub-analysis of a prospective randomized trial enrolling 248 patients submitted to en-bloc vs conventional TURBT from 03/2018 to 06/2021. The DEpth of Endoscopic Perforation (DEEP) scale is as follows: "0" visible muscular layer with no perivesical fat; "1" visible muscle fibers with spotted perivesical fat; "2" exposition of perivesical fat; "3" intraperitoneal perforation. Logistic and linear regression models were used to investigate predictors of high-grade perforations (DEEP 2-3) and to assess whether the DEEP scale independently predicted patients' postoperative outcomes. RESULTS: A total of 146/248 (58.9%), 56/248 (22.6%), 41/248 (16.5%), 5/248 (2.0%) patients presented DEEP grade 0, 1, 2, and 3, respectively. Female gender [B coeff. 0.255 (95% CI 0.001-0.513); p = 0.05], tumor location [B coeff. 0.188 (0.026-0.339); p = 0.015], and obturator-nerve reflex [B coeff. 0.503 (0.148-0.857); p = 0.006] were independent predictors of DEEP. The scale predicted independently major complications [Odd Ratio (OR) 2.221 (1.098-4.495); p = 0.026], no post-operative chemotherapy intravesical instillation [OR 9.387 (2.434-36.200); p = 0.001], longer irrigation time [B coeff. 0.299 (0.166-0.441); p < 0.001] and hospital stay [B coeff. 0.315 (0.111-0.519); p = 0.003]. CONCLUSION: The DEEP scale provides a visual tool for grading bladder perforation during TURBT, which can help physicians standardize complication reporting and plan postoperative management accordingly.

Topical instillation of BCG immunotherapy for biopsy-proven primary upper urinary tract carcinoma in situ: A single institution series and systematic review.

Primary upper tract carcinoma in situ (UTcis) is a rare disease whose diagnosis and natural history are poorly understood. Radical nephroureterectomy is the standard of care but in imperatives or selected cases, topical instillations of Bacillus Calmette-Guérin (BCG) may represent a good alternative. The aim of this study was to report the histologic response to BCG instillations for the treatment of biopsy-proven UTcis and to systematically assess the current evidence on topical BCG instillation for the treatment of UTcis. This is a retrospective analysis of patients with biopsy-proven UTcis treated with BCG instillation between 1995 and 2020 in an expert center. The initial diagnosis was performed by a standardized random biopsy scheme during ureterorenoscopy (URS) in patients with positive cytology but negative CT and bladder biopsies. BCG course consisted of 6 weekly instillation of 81 mg Immucyst (Sanofi Pasteur MSD AG, Baar, Switzerland). Administration techniques were single-J, double-J and nephrostomy tube. The primary outcome was the rate of complete histological response at the 3-month 2nd-look-URS. Kaplan-Meier analysis curves assessed recurrence- and progression-free survival. A total of 22 patients (23 renal units) were included. Twenty-one (91.3%) patients completed the planned 6-week instillation cycle. Only one major complication was recorded (renal tuberculosis). Twenty patients had a 3-month 2nd-look-URS, with a complete histological response achieved in 17/20 cases (85%). After a median time of follow-up of 40 months (30-62), 8/20 patients harbored disease recurrence, including 5 cases of disease progression (≥pT2). The main limitations are the retrospective and non-comparative design of the study. Our systematic review (CRD42022324876) identified 15 studies (289 renal units). UTcis suffers from the lack of a standardized definition, and considerable heterogeneity has been found in making the diagnosis and assessing the response to treatment. Our study is the first to propose a histological diagnosis of UTcis as well as a histological re-evaluation of the response to treatment. Topical instillations of BCG appear to be a promising alternative, avoiding radical treatment in the majority of cases.

Three-dimensional Augmented Reality-guided Robotic-assisted Kidney Transplantation: Breaking the Limit of Atheromatic Plaques.

BACKGROUND: Robotic-assisted kidney transplantation (RAKT) has shown solid results as a minimally invasive alternative to the standard open approach (open kidney transplantation [OKT]). However, RAKT is still limited in those cases where the recipient's iliac vessels present atherosclerotic plaques, frequently found in elder patients and in those subjected to long-term hemodialysis. Unlike OKT, where the surgeon can palpate the arterial plaques, in minimally invasive surgery the haptic feedback is missing, making the vascular clamping and arteriotomy unsafe. OBJECTIVE: To employ three-dimensional (3D) imaging reconstruction using augmented reality (AR) to intraoperatively locate the plaques during the crucial steps of kidney transplantation. DESIGN, SETTING, AND PARTICIPANTS: Our study was conducted according to the Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) model for surgical innovation. Three-dimensional virtual models were obtained from high-accuracy computed tomography scan imaging and superimposed on the vessels during RAKT using the Da Vinci console software. SURGICAL PROCEDURE: Three-dimensional AR-guided robotic-assisted kidney transplantation. MEASUREMENTS: The correspondence of virtual models with the real anatomy of patients was assessed comparing vessels' and plaques' measures. RESULTS AND LIMITATIONS: We tested the possibility of using the AR in the setting of vascular surgery by checking the correspondence of the virtual models to the real vessels. During the accuracy assessment, we investigated the anatomy of the iliac plaques and the capacity of the virtual models to correctly represent them. Finally, we tested the efficacy of the virtual model superimposition on the real vessels with plaques during RAKT in the recipients of living donor grafts. The main limitation consists in training needed to correctly superimpose virtual models on the real field. CONCLUSIONS: The employment of 3D AR allowed surgeons to overcome one of the main limitations of RAKT, setting the foundation to expand its indications to patients with advanced atheromatic vascular disease. PATIENT SUMMARY: The use of three-dimensional augmented reality guidance during kidney transplantation (KT) has the potential to "navigate" the surgeon during KT, allowing a safer procedure in patients with atheromatic vascular disease.

En Bloc Versus Conventional Transurethral Resection of Bladder Tumors: A Single-center Prospective Randomized Noninferiority Trial.

BACKGROUND: It has been proposed that en bloc resection of bladder tumor (ERBT) improves the quality of tumor resection. A recent international collaborative consensus statement on ERBT underlined the lack of high-quality prospective studies precluding the achievement of solid conclusion on ERBT. OBJECTIVE: To compare conventional transurethral resection of bladder tumor (cTURBT) and ERBT. DESIGN, SETTING, AND PARTICIPANTS: This study (NCT04712201) was a prospective, randomized, noninferiority trial enrolling patients diagnosed with bladder cancer (BC) undergoing endoscopic intervention. Inclusion criteria were: tumor size ≤3 cm, three or fewer lesions, and no sign of muscle invasion and/or ureteral involvement. For a noninferiority rate in BC staging of 5% (α risk 2.5%; ß risk 20%), a total of 300 subjects were randomized to ERBT treatment at a 1:1.5 allocation ratio. INTERVENTION: TURBT and ERBT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the presence of detrusor muscle at final histology. Secondary outcomes include BC staging, T1 substaging, artifacts, complications, the rate of adjuvant treatment, and oncological outcomes. RESULTS AND LIMITATIONS: From April 2018 to June 2021, 300 patients met the inclusion criteria. Of these, 248 (83%) underwent the assigned intervention: 108 patients (44%) underwent cTURBT and 140 (57%) underwent ERBT. The rate of detrusor muscle presence for ERBT was noninferior to that for TURBT (94% vs 95%; p = 0.8). T1 substaging was feasible in 80% of cTURBT cases versus 100% of ERBT cases (p = 0.02). Complication rates, rates of postoperative adjuvant treatment, catheterization time, and hospital stay were comparable between the two groups (p > 0.05). The recurrence rate at median follow-up of 15 mo (interquartile range 7-28) was 18% for cTURBT versus 13% for ERBT (p = 0.16). Limitations include the single high-volume institution and the short-term follow-up. CONCLUSIONS: Our study has the highest level of evidence for comparison of ERBT versus TURBT. ERBT was noninferior to TURBT for BC staging. The rate of T1 substaging feasibility was significantly higher with ERBT. PATIENT SUMMARY: We compared two techniques for removing tumors from the bladder. The en bloc technique removes the tumor in one piece and is not inferior to the conventional method in terms of the quality of the surgical resection and cancer staging assessment.