The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial.

PURPOSE: To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN). METHODS: The CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF). The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression. RESULTS: 324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR - 3.7 vs - 7.5 ml/min (p < 0.001); AV-SRF - 1% vs - 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] - 0.52, p = 0.019), age (RC - 0.35, p = 0.001) and baseline eGFR (RC - 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC - 0.30, p = 0.018), baseline SRF (RC - 0.76, p < 0.001) and RENAL score (RC - 0.60. p = 0.028). The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered. CONCLUSIONS: Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.

The IRON Study: Investigation of Robot-assisted Versus Open Nephron-sparing Surgery.

Background: Current literature does not provide large-scale data regarding clinical outcomes of robot-assisted (RAPN) versus open (OPN) partial nephrectomy. Moreover, data assessing predictors of long-term oncologic outcomes after RAPN are scarce. Objective: To compare perioperative, functional, and oncologic outcomes of RAPN versus OPN, and to investigate the predictors of oncologic outcomes after RAPN. Design setting and participants: This study included 3467 patients treated with OPN (n = 1063) or RAPN (n = 2404) for a single cT1-2N0M0 renal mass from 2004 to 2018 at nine high-volume European, North American, and Asian institutions. Outcome measurements and statistical analysis: The study outcomes were short-term postoperative, functional, and oncologic outcomes. Regression models investigated the effect of surgical approach (open vs Robot assisted) on study outcomes, and interaction tests were used for subgroup analyses. Propensity score matching for demographic and tumor characteristics was used in sensitivity analyses. Multivariable Cox-regression analyses identified predictors of oncologic outcomes after RAPN. Results and limitations: Baseline characteristics were similar between patients receiving RAPN and OPN, with only few differences. After adjusting for confounding, RAPN was associated with lower odds of intraoperative (odds ratio [OR]: 0.39, 95% confidence interval [CI]: 0.22, 0.68) and Clavien-Dindo ≥2 postoperative (OR: 0.29, 95% CI: 0.16, 0.50) complications (both p < 0.05). This association was not affected by comorbidities, tumor dimension, PADUA score, or preoperative renal function (all p > 0.05 on interaction tests). On multivariable analyses, we found no differences between the two techniques with respect to functional and oncologic outcomes (all p > 0.05). Overall, there were 63 and 92 local recurrences and systemic progressions, respectively, with a median follow-up after surgery of 32 mo (interquartile range: 18, 60). Among patients receiving RAPN, we assessed predictors of local recurrence and systemic progression with discrimination accuracy (ie, C-index) that ranged from 0.73 to 0.81. Conclusions: While cancer control and long-term renal function did not differ between RAPN and OPN, we found that the intra- and postoperative morbidity-especially in terms of complications-was lower after RAPN than after OPN. Our predictive models allow surgeons to estimate the risk of adverse oncologic outcomes after RAPN, with relevant implications for preoperative counseling and follow-up after surgery. Patient summary: In this comparative study on robotic versus open partial nephrectomy, functional and oncologic outcomes were similar between the two techniques, with lower morbidity-especially in terms of complications-for robot-assisted surgery. The assessment of prognosticators for patients receiving robot-assisted partial nephrectomy may help in preoperative counseling and provides relevant data to tailor postoperative follow-up.

External validation of yonsei nomogram predicting chronic kidney disease development after partial nephrectomy: An international, multicenter study.

OBJECTIVE: To externally validate Yonsei nomogram. METHODS: From 2000 through 2018, 3526 consecutive patients underwent on-clamp PN for cT1 renal masses at 23 centers were included. All patients had two kidneys, preoperative eGFR ≥60 ml/min/1.73 m2, and a minimum follow-up of 12 months. New-onset CKD was defined as upgrading from CKD stage I or II into CKD stage ≥III. We obtained the CKD-free progression probabilities at 1, 3, 5, and 10 years for all patients by applying the nomogram found at https://eservices.ksmc.med.sa/ckd/. Thereafter, external validation of Yonsei nomogram for estimating new-onset CKD stage ≥III was assessed by calibration and discrimination analysis. RESULTS AND LIMITATION: Median values of patients' age, tumor size, eGFR and follow-up period were 47 years (IQR: 47-62), 3.3 cm (IQR: 2.5-4.2), 90.5 ml/min/1.73 m2 (IQR: 82.8-98), and 47 months (IQR: 27-65), respectively. A total of 683 patients (19.4%) developed new-onset CKD. The 5-year CKD-free progression rate was 77.9%. Yonsei nomogram demonstrated an AUC of 0.69, 0.72, 0.77, and 0.78 for the prediction of CKD stage ≥III at 1, 3, 5, and 10 years, respectively. The calibration plots at 1, 3, 5, and 10 years showed that the model was well calibrated with calibration slope values of 0.77, 0.83, 0.76, and 0.75, respectively. Retrospective database collection is a limitation of our study. CONCLUSIONS: The largest external validation of Yonsei nomogram showed good calibration properties. The nomogram can provide an accurate estimate of the individual risk of CKD-free progression on long-term follow-up.

Impact of Metastasectomy on Cancer Specific and Overall Survival in Metastatic Renal Cell Carcinoma: Analysis of the REMARCC Registry.

BACKGROUND: Treatment paradigms for management of metastatic renal cell carcinoma (mRCC) are evolving. We examined impact of surgical metastasectomy on survival across in mRCC stratified by risk-group. METHODS: Multicenter retrospective analysis from the Registry of Metastatic RCC database. The cohort was subdivided utilizing Motzer criteria (favorable-, intermediate-, high-risk). Primary outcome was all-cause mortality (ACM)/overall survival (OS); secondary outcome was cancer-specific mortality (CSM)/cancer-specific survival (CSS). Impact of metastasectomy was analyzed via Cox-Regression analysis adjusting for potential prognostic variables and Kaplan-Meier analysis (KMA) within each risk-group. RESULTS: Four hundred thirty-one patients (59 favorable-risk, 274 intermediate-risk, 98 high-risk; median follow-up 27.2 months) were analyzed. Metastasectomy was performed in 22 (37%), 66 (24%), and 32 (16%) of favorable-, intermediate- and high-risk groups (P = .012). Median number of metastases at diagnosis differed significantly (favorable-risk 2, intermediate-risk 3.4, high-risk 5.1, P < .001). On Cox-regression, high-risk (HR = 1.72, P = .002) was associated with worsened ACM, while metastasectomy was associated with improved ACM (HR = 0.56, P = .005). On KMA, median OS (months) was longer with metastasectomy in favorable- (92.7 vs. 25.8, P = .003) and intermediate-risk (26.3 vs. 20.1, P = .038), but not high-risk (P = .911) groups. Metastasectomy was associated with longer CSS in favorable- (76.1 vs. 32.8, P = .004) but not intermediate- (P = .06) and high-risk (P = .595) groups. CONCLUSIONS: Metastasectomy was independently associated with improved ACM and CSM, as well as improved CSS and OS in favorable- and intermediate-risk mRCC patients. Metastasectomy may be considered as component of multimodal management strategy in favorable and intermediate-risk subgroups. In high-risk patients, metastasectomy should be deferred except in select circumstances.

Predictors of Positive Surgical Margins after Robot-Assisted Partial Nephrectomy for Localized Renal Tumors: Insights from a Large Multicenter International Prospective Observational Project (The Surface-Intermediate-Base Margin Score Consortium).

Background: To explore predictors of positive surgical margins (PSM) after robotic partial nephrectomy (PN) in a large multicenter international observational project, harnessing the Surface-Intermediate-Base (SIB) margin score to report the resection technique after PN in a standardized way. Methods: Data from consecutive patients with cT1-2N0M0 renal masses treated with PN from September 2014 to March 2015 at 16 tertiary referral centers and included in the SIB margin score International Consortium were prospectively collected. For the present study, only patients treated with robotic PN were included. Uni- and multivariable analysis were fitted to explore clinical and surgical predictors of PSMs after PN. Results: Overall, 289 patients were enrolled. Median (IQR) preoperative tumor size was 3.0 (2.3−4.2) cm and median (IQR) PADUA score was 8 (7−9). SIB scores of 0−2 (enucleation), 3−4 (enucleoresection) and 5 (resection) were reported in 53.3%, 27.3% and 19.4% of cases, respectively. A PSM was recorded in 18 (6.2%) patients. PSM rate was 4.5%, 11.4% and 3.6% in case of enucleation, enucleoresection and resection, respectively. Patients with PSMs had tumors with a higher rate of contact with the urinary collecting system (55.6% vs. 27.3%; p < 0.001) and a longer median warm ischemia time (22 vs. 16 min; p = 0.02) compared with patients with negative surgical margins, while no differences emerged between the two groups in terms of other tumor features (i.e., pathological diameter, PADUA score). In multivariable analysis, only enucleoresection (SIB score 3−4) versus enucleation (SIB score 0−2) was found to be an independent predictor of PSM at final pathology (HR: 2.68; 95% CI: 1.25−7.63; p = 0.04), while resection (SIB score 5) was not. Conclusions: In our experience, enucleoresection led to a higher risk of PSMs as compared to enucleation. Further studies are needed to assess the differential impacts of resection technique and surgeon's experience on margin status after robotic PN.

Impact of Trifecta definition on rates and predictors of "successful" robotic partial nephrectomy for localized renal masses: results from the Surface-Intermediate-Base Margin Score International Consortium.

BACKGROUND: Over the years, five different Trifecta score definitions have been proposed to optimize the framing of "success" in partial nephrectomy (PN) field. However, such classifications rely on different metrics. The aim of the present study was to explore how the success rate of robotic PN, as well as its drivers, vary according to the currently available definitions of Trifecta. METHODS: Data from consecutive patients with cT1-2N0M0 renal masses treated with robotic PN at 16 referral centers from September 2014 to March 2015 were prospectively collected. Trifecta rate was defined for each of the currently available definitions. Multivariable logistic regression analysis was used to evaluate possible predictors of "Trifecta failure" according to the different adopted formulation. RESULTS: Overall, 289 patients met the inclusion criteria. Among the definitions, Trifecta rates ranged between 66.4% and 85.9%. Multivariable analysis showed that predictors for "Trifecta failure" were mainly tumor-related (i.e. tumor's nephrometry) for those Trifecta scores relying on WIT as a surrogate metric for postoperative renal function deterioration (definitions 1,2), while mainly surgery-related (i.e. ischemia time and excision strategy) for those including the percentage change in postoperative eGFR as the functional cornerstone of Trifecta (definitions 3-5). CONCLUSIONS: There was large variability in rates and predictors of "unsuccessful PN" when using different Trifecta scores. Further research is needed to improve the value of the Trifecta metrics, integrating them into routine patient counseling and standardized assessment of surgical quality across institutions.

A Nomogram for the Prediction of Intermediate Significant Renal Function Loss After Robot-assisted Partial Nephrectomy for Localized Renal Tumors: A Prospective Multicenter Observational Study (RECORd2 Project).

BACKGROUND: Robot-assisted partial nephrectomy (RAPN) is increasingly adopted for the treatment of localized renal tumors; however, rates and predictors of significant renal function (RF) loss after RAPN are still poorly investigated, especially at a long-term evaluation. OBJECTIVE: To analyze the predictive factors and develop a clinical nomogram for predicting the likelihood of ultimate RF loss after RAPN. DESIGN, SETTING, AND PARTICIPANTS: We prospectively evaluated all patients treated with RAPN in a multicenter series (RECORd2 project). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Significant RF loss was defined as >25% reduction in estimated glomerular filtration rate (eGFR) from preoperative assessment at 48th month follow-up after surgery. Uni- and multivariable logistic regression analyses for RF loss were performed. The area under the receiving operator characteristic curve (AUC) was used to quantify predictive discrimination. A nomogram was created from the multivariable model. RESULTS AND LIMITATIONS: A total of 981 patients were included. The median age at surgery was 64.2 (interquartile range [IQR] 54.3-71.4) yr, and 62.4% of patients were male. The median Charlson Comorbidity Index (CCI) was 1 (IQR 0-2), 12.9% of patients suffered from diabetes mellitus, and 18.6% of patients showed peripheral vascular disease (PVD). The median Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score was 7 (IQR 7-9). Imperative indications to partial nephrectomy were present in 3.6% of patients. Significant RF loss at 48th month postoperative evaluation was registered in 108 (11%) patients. At multivariable analysis, age (p = 0.04), female gender (p < 0.0001), CCI (p < 0.0001), CCI (p < 0.0001), diabetes (p < 0.0001), PVD (p < 0.0001), eGFR (p = 0.02), imperative (p = 0.001) surgical indication, and PADUA score (p < 0.0001) were found to be predictors of RF loss. The developed nomogram including these variables showed an AUC of 0.816. CONCLUSIONS: We developed a clinical nomogram for the prediction of late RF loss after RAPN using preoperative and surgical variables from a large multicenter dataset. PATIENT SUMMARY: We developed a nomogram that could represent a clinical tool for early detection of patients at the highest risk of significant renal function impairment after robotic conservative surgery for renal tumors.

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

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/1.73m2. 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/1.73m2.

Is off-clamp robot-assisted partial nephrectomy beneficial for renal function? Data from the CLOCK trial.

OBJECTIVES: To compare the functional outcomes of on- vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT). MATERIALS AND METHODS: The CLOCK study (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy; NCT02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre- and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on-clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off-clamp condition it was not allowed throughout the procedure. The primary endpoint was 6-month absolute variation in estimated glomerular filtration rate (AV-GFR); secondary endpoints were: 12, 18 and 24-month AV-GFR; 6-month estimated glomerular filtration rate variation >25% rate (RV-GFR >25); and absolute variation in ipsilateral split renal function (AV-SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV-GFR and AV-SRF were compared using analysis of covariation, and RV-GFR >25 was assessed using multivariable logistic regression. Intention-to-treat (ITT) and per-protocol analyses (PP) were performed. RESULTS: A total of 160 and 164 patients were randomly assigned to on- and off-clamp RAPN, respectively; crossover was observed in 14% and 43% of the on- and off-clamp arms, respectively. We were unable to find any statistically significant difference between on- vs off-clamp with regard to the primary endpoint (ITT: 6-month AV-GFR -6.2 vs -5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval [CI] -3.1 to 3.4 [P = 0.8]; PP: 6-month AV-GFR -6.8 vs -4.2 mL/min, mean difference 1.6 mL/min, 95% CI -2.3 to 5.5 [P = 0.7]) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis. CONCLUSION: In patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on- vs off-clamp RAPN.

External validation of the Palacios' equation: a simple and accurate tool to estimate the new baseline renal function after renal cancer surgery.

PURPOSE: To externally validate the Palacios' equation estimating the new baseline glomerular filtration rate (NB-GFR) after partial or radical-nephrectomy (PN, RN) for Renal cancer carcinoma (RCC). MATERIALS AND METHODS: Our research group recently published two studies that investigated the association between renal function and cancer-specific survival in RCC. The first one included 3457 patients undergone RN or PN for a cT1-2 RCC coming from five high-volume centers; the second one considered 1767 patients undergone RN or PN for a cT1-4 RCC in a single high-volume center. From such datasets, available complete patients' data were used to calculate the predicted NB-GFR through the Palacios' equation: predicted NB-GFR = 35.03 + 0.65 ∙ preoperative GFR - 18.19 ∙ (if radical nephrectomy) - 0.25 ∙ age + 2.83 ∙ (if tumor size > 7 cm) - 2.09 ∙ (if diabetes). The observed NB-GFR was calculated by the CKD-EPI equation on serum creatinine at 3-12 months after surgery. Concordance between observed and predicted NB-GFR was evaluated by Lin's concordance correlation coefficient and Bland-Altman analysis. RESULTS: 2419 patients were included (1210, cohort #1; 1219, cohort #2). The median observed NB-GFR value in cohorts #1 and #2 was 73.0 ml/min/1.73 m2 (IQR 56.1-90.1) and 64.2 ml/min/1.73 m2 (IQR 49.6-83); the median predicted NB-GFR was 71.1 ml/min/1.73 m2 (IQR 58-81.5) and 62.6 ml/min/1.73m2 (IQR 47.9-75.9). The concordance line showed a slope of 0.80 and 0.86, and an intercept at 11.02 and 5.41 ml/min/1.73 m2 in the cohort#1 and #2, respectively. The Palacio's equation moderately over-estimated and under-estimated NB-GFR, for values below and above the cut-off of 50 ml/min/1.73 m2 and 35 ml/min/1.73m2 in cohort#1 and #2. The Lin's concordance correlation coefficient was 0.79 (95% CI 0.77-0.81) and 0.83 (95% CI 0.82-0.85). CONCLUSIONS: We confirm the predictive performances of Palacios' equation, supporting its utilization in clinical practice.

Impact of surgical approach and resection technique on the risk of Trifecta Failure after partial nephrectomy for highly complex renal masses.

INTRODUCTION: We aimed to compare the outcomes of open vs robotic partial nephrectomy (PN), focusing on predictors of Trifecta failure in patients with highly complex renal masses. PATIENTS AND METHODS: We queried the prospectively collected database from the SIB International Consortium, including 507 consecutive patients with cT1-2N0M0 renal masses treated at 16 high-volume referral centres, to select those with highly complex (PADUA score ≥10) tumors undergoing PN. RT was classified as enucleation, enucleoresection or resection according to the SIB score. Trifecta was defined as achievement of negative surgical margins, no acute kidney injury and no Clavien-Dindo grade ≥2 postoperative surgical complications. Multivariable logistic regression analysis was used to assess independent predictors of Trifecta failure. RESULTS: 113 patients were included. Patients undergoing open PN (n = 47, 41.6%) and robotic PN (n = 66, 58.4%) were comparable in baseline characteristics. RT was classified as enucleation, enucleoresection and resection in 46.9%, 34.0% and 19.1% of open PN, and in 50.0%, 40.9% and 9.1% of robotic PN (p = 0.28). Trifecta was achieved in significantly more patients after robotic PN (69.7% vs. 42.6%, p = 0.004). On multivariable analysis, surgical approach (open vs robotic, OR: 2.62; 95%CI: 1.11-6.15, p = 0.027) and tumor complexity (OR for each additional unit of the PADUA score: 2.27; 95%CI: 1.27-4.06, p = 0.006) were significant predictors of Trifecta failure, while RT was not. The study is limited by lack of randomization; as such, selection bias and confounding cannot be entirely ruled out. CONCLUSIONS: Tumor complexity and surgical approach were independent predictors of Trifecta failure after PN for highly complex renal masses.

Management of local recurrence after radical nephrectomy: surgical removal with or without systemic treatment is still the gold standard. Results from a multicenter international cohort.

OBJECTIVE: To evaluate the survival outcomes of patients with local recurrence after radical nephrectomy (RN) and to test the effect of surgery, as monotherapy or in combination with systemic treatment, on cancer-specific mortality (CSM). METHODS: Patients with local recurrence after RN were abstracted from an international dataset. The primary outcome was CSM. Cox's proportional hazard models tested the main predictors of CSM. Kaplan-Meier method estimates the 3-year survival rates. RESULTS: Overall, 96 patients were included. Of these, 44 (45.8%) were metastatic at the time of recurrence. The median time to recurrence after RN was 14.5 months. The 3-year cancer-specific survival rates after local recurrence were 92.3% (± 7.4%) for those who were treated with surgery and systemic therapy, 63.2% (± 13.2%) for those who only underwent surgery, 22.7% (± 0.9%) for those who only received systemic therapy and 20.5% (± 10.4%) for those who received no treatment (p < 0.001). Receiving only medical treatment (HR: 5.40, 95% CI 2.06-14.15, p = 0.001) or no treatment (HR: 5.63, 95% CI 2.21-14.92, p = 0.001) were both independently associated with higher CSM rates, even after multivariable adjustment. Following surgical treatment of local recurrence 8 (16.0%) patients reported complications, and 2/8 were graded as Clavien-Dindo ≥ 3. CONCLUSIONS: Surgical treatment of local recurrence after RN, when feasible, should be offered to patients. Moreover, its association with a systemic treatment seems to warrantee adjunctive advantages in terms of survival, even in the presence of metastases.

Robot-assisted vesico-vaginal fistula repair: technical nuances

ABSTRACT Introduction: Vesico-vaginal fistula (VVF) is a rare event in Western countries and are mainly consequent to iatrogenic injuries (1, 2). When conservative management fails, surgical repair is needed, although timing and surgical approach (open or minimally invasive (3)) are still controversial (4, 5). Herein we present a step-by-step description of robot-assisted vesico-vaginal fistula repair. Material and Methods: From 2015 to 2018 six patients underwent robotic vesico-vaginal fistula repair. Pre-operative cystoscopy was performed to identify the fistulous tract. The ureters were stented. A small catheter was inserted in the fistula. A longitudinal cystotomy was performed, then a dissection of the posterior bladder from the anterior vaginal wall was performed and the fistolous tract was excised. The vagina was sutured horizontally. Four patients underwent omental flap and two pericolic fat interposition. The bladder was closed with a double-layer suture. Results: All the vesico-vaginal fistulas developed after previous gynaecological surgery. The median operative time was 160 minutes [interquartile range (IQR) (146-177)]. Intraoperative blood loss was 25 (IQR 0-50) mL. No post-operative complications were recorded. Ureteral stents were removed at 4th post-operative day. Catheter was removed 13 (IQR 11-15) days after surgery after cystography assessment. One patient had Clavien I complication (ileus). Surgical pathology report was negative. No fistula recurrence was reported during follow-up. Conclusions: In our experience, robot-assisted fistula repair is a feasible and safe procedure. It presents the advantages of minimally invasive approaches and seems to provide low morbidity and good outcomes. Compared to transvaginal approach, the robotics allows to manage more complex cases with high success rate (6).

A thigh urinary fistula following radical prostatectomy and external beam radiation therapy for prostate cancer: a case report.

Urinary fistula is a rare but severe complication which could occur after radiation therapy for prostate cancer (PCa). We describe the case of an inner thigh urinary fistula in a patient treated with radical prostatectomy and adjuvant radiation therapy for PCa. A 76-year-old man presented to the emergency room complaining of right thigh swelling, pain and fever. Computed tomography scan and urethra-cystography showed bladder-neck leakage and fluid collection, extended from the pelvis to the right inner thigh. Patient was treated with ultrasound-guided drainage and intravenous antibiotics. Timely diagnosis and treatment are necessary in order to reduce possible evolution to necrotizing fasciitis.

Perioperative and Mid-term Oncological and Functional Outcomes After Partial Nephrectomy for Complex (PADUA Score ≥10) Renal Tumors: A Prospective Multicenter Observational Study (the RECORD2 Project).

BACKGROUND: Partial nephrectomy (PN) for complex renal masses has a non-negligible risk of perioperative complications. Furthermore, late functional and oncological outcomes of patients submitted to these challenging surgeries still remain to be determined. OBJECTIVES: To report the perioperative and mid-term oncological and functional outcomes of PN for complex masses (Preoperative Aspects and Dimensions Used for an Anatomical [PADUA] score≥10) in a large multicenter prospective observational study. DESIGN, SETTING, AND PARTICIPANTS: We prospectively evaluated patients treated with PN for complex renal tumors at 26 urological centers (Registry of Conservative and Radical Surgery for Cortical Renal Tumor Disease [RECORD2] project). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariate logistic regression analyses explored the predictors of surgical complications. Multivariable Cox regression analyses estimated the hazard of renal function loss and disease recurrence. Kaplan-Meier estimates assessed the probability of survival. RESULTS AND LIMITATIONS: In total, 410 patients who underwent PN for complex masses were evaluated. Clinical T1b and T2 tumors accounted for 43.2% and 9.8% of the cases. Overall, 45.9%, 18.8%, and 35.4% of patients underwent open, laparoscopic, and robotic PN, respectively. Intraoperative complications occurred in 15 (3.6%) patients, while postoperative surgical complications were recorded in 76 (18.5%) patients. At multivariable analysis, preoperative hemoglobin (odds ratio [OR]: 0.67; p<0.001) and open (OR: 3.91; p<0.001) versus robotic surgical approach were found to be the only predictors of surgical complications. An estimated glomerular filtration rate drop of >25% from baseline was observed in 30.2% and 17.6% of patients at 1st month and 2 yr after surgery, respectively. Two-year recurrence-free survival was 97.1%; positive surgical margins (hazard ratio [HR]: 3.35; p=0.009), nucleolar grading (HR: 5.61; p<0.001), and tumor stage (HR: 2.62; p=0.05) were associated with recurrence. CONCLUSIONS: In a large series, PN for complex renal masses was a safe technique with an acceptable rate of perioperative complications and excellent mid-term oncological and functional results. PATIENT SUMMARY: In this study, we evaluated peri- and postoperative outcomes of patients treated with partial nephrectomy for complex renal masses. Open surgery was associated with higher complications than the robotic approach. Some histological features were found to be associated with disease recurrence.

Outcomes of minimally invasive partial nephrectomy among very elderly patients: report from the RESURGE collaborative international database.

The aim of the study was to perform a comprehensive investigation of clinical outcomes of robot-assisted partial nephrectomy (RAPN) or laparoscopic partial nephrectomy (LPN) in elderly patients presenting with a renal mass. The REnal SURGery in Elderly (RESURGE) collaborative database was queried to identify patients aged 75 or older diagnosed with cT1-2 renal mass and treated with RAPN or LPN. Study outcomes were: overall complications (OC); warm ischemia time (WIT) and 6-month estimated glomerular filtration rate (eGFR); positive surgical margins (PSM), disease recurrence (REC), cancer-specific mortality (CSM) and other-cause mortality (OCM). Descriptive statistics, Kaplan-Meier, smoothed Poisson plots and logistic and linear regression models (MVA) were used. Overall, 216 patients were included in this analysis. OC rate was 34%, most of them being of low Clavien grade. Median WIT was 17 minutes and median 6-month eGFR was 54 ml/min/1.73 m2. PSM rate was 5%. After a median follow-up of 20 months, the 5-year rates of REC, CSM and OCM were 4, 4 and 5%, respectively. At MVA predicting perioperative morbidity, RAPN relative to LPN (odds ratio [OR] 0.33; p <0.0001) was associated with lower OC rate. At MVA predicting functional outcomes, RAPN relative to LPN was associated with shorter WIT (estimate [EST] -4.09; p <0.0001), and with higher 6-month eGFR (EST 6.03; p = 0.01). In appropriately selected patients with small renal masses, minimally-invasive PN is associated with acceptable perioperative outcomes. The use of a robotic approach over a standard laparoscopic approach can be advantageous with respect to clinically relevant outcomes, and it should be preferred when available.

Renal Function Impairment Below Safety Limits Correlates With Cancer-specific Mortality in Localized Renal Cell Carcinoma: Results From a Single-center Study.

BACKGROUND: A recent multi-center study showed how estimated glomerular filtration rate (eGFR) and cancer-specific mortality (CSM) are linearly and inversely related in organ-confined renal cell carcinoma (RCC) whenever the eGFR decreases below specific thresholds. We addressed our previous work limitations related to heterogeneity and missing data, and explored the relationship between eGFR and CSM also in locally advanced RCC. MATERIALS AND METHODS: All patients with RCC treated with either partial or radical nephrectomy from 1990 to 2018 at a single institution and with complete data on renal function were included. eGFR was managed as a time-dependent variable. The relationship between eGFR and CSM was analyzed using a Fine and Gray multivariable competing risks framework. Subdistribution hazard ratios (SHRs) were calculated accounting for deaths from other causes. RESULTS: Multivariable competing risks analysis showed a "piecewise" relationship between eGFR and CSM, with an inverse linear correlation for eGFR values below 85 mL/min. Below this breakpoint, a significant relationship existed between eGFR and CSM in both clinical (SHR, 1.27; P < .001) and pathologic (SHR, 1.27; P = .001) models in stage I to II RCC subgroup. Conversely, no significance was recorded in this subgroup when considering eGFR values above 85 mL/min. In the stage III to IV subgroup, no significant relationships were recorded, regardless of eGFR values. The retrospective design with inherent biases in data collection represents a limitation. CONCLUSIONS: In patients undergoing surgery for stage I to II RCC, preservation of renal function over "safety limits" is protective from CSM.

Partial versus radical nephrectomy in very elderly patients: a propensity score analysis of surgical, functional and oncologic outcomes (RESURGE project).

PURPOSE: To compare the outcomes of PN to those of RN in very elderly patients treated for clinically localized renal tumor. PATIENTS AND METHODS: A purpose-built multi-institutional international database (RESURGE project) was used for this retrospective analysis. Patients over 75 years old and surgically treated for a suspicious of localized renal with either PN or RN were included in this database. Surgical, renal function and oncological outcomes were analyzed. Propensity scores for the predicted probability to receive PN in each patient were estimated by logistic regression models. Cox proportional hazard models were estimated to determine the relative change in hazard associated with PN vs RN on overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM). RESULTS: A total of 613 patients who underwent RN were successfully matched with 613 controls who underwent PN. Higher overall complication rate was recorded in the PN group (33% vs 25%; p = 0.01). Median follow-up for the entire cohort was 35 months (interquartile range [IQR] 13-63 months). There was a significant difference between RN and PN in median decline of eGFR (39% vs 17%; p < 0.01). PN was not correlated with OM (HR = 0.71; p = 0.56), OCM (HR = 0.74; p = 0.5), and showed a protective trend for CSM (HR = 0.19; p = 0.05). PN was found to be a protective factor for surgical CKD (HR = 0.28; p < 0.01) and worsening of eGFR in patients with baseline CKD. Retrospective design represents a limitation of this analysis. CONCLUSIONS: Adoption of PN in very elderly patients with localized renal tumor does not compromise oncological outcomes, and it allows better functional preservation at mid-term (3-year) follow-up, relative to RN. Whether this functional benefit translates into a survival benefit remains to be determined.

Impact of Resection Technique on Perioperative Outcomes and Surgical Margins after Partial Nephrectomy for Localized Renal Masses: A Prospective Multicenter Study.

PURPOSE: The impact of resection technique on partial nephrectomy outcomes is controversial. The aim of this study was to evaluate the pattern of resection techniques during partial nephrectomy and the impact on perioperative outcomes, acute kidney injury, positive surgical margins and the achievement of the Trifecta (negative surgical margins, no perioperative Clavien-Dindo grade 2 or greater surgical complications and no postoperative acute kidney injury). MATERIALS AND METHODS: We prospectively collected data on consecutive patients with cT1-2N0M0 renal masses treated with partial nephrectomy at a total of 16 referral centers from September 2014 to March 2015. After partial nephrectomy the resection technique was classified by the surgeon as enucleation, enucleoresection or resection according to the SIB (Surface-Intermediate-Base) margin scores 0 to 2, 3 or 4 and 5, respectively. Multivariable logistic regression analysis was done to evaluate the potential impact of the resection technique on postoperative surgical complications, positive surgical margins, acute kidney injury and Trifecta achievement. RESULTS: Overall 507 patients were included in analysis. The resection technique was classified as enucleation in 266 patients (52%), enucleoresection in 150 (30%) and resection in 91 (18%). The resection technique (enucleoresection vs enucleation and resection) was the only significant predictor of positive surgical margins. Tumor complexity, surgical approach (open and laparoscopic vs robotic) and resection technique (enucleoresection vs enucleation) were significant predictors of Clavien-Dindo grade 2 or greater surgical complications. The surgical approach (open and laparoscopic vs robotic), the resection technique (enucleoresection vs enucleation) and warm ischemia time were significantly associated with postoperative acute kidney injury and Trifecta achievement. CONCLUSIONS: Resection techniques significantly impact surgical complications, early functional outcomes and positive surgical margins after partial nephrectomy of localized renal masses.