Transperineal laser ablation of the prostate as a treatment for benign prostatic hyperplasia and prostate cancer: The results of a Delphi consensus project.

Objective: To evaluate transperineal laser ablation (TPLA) with Echolaser® (Echolaser® TPLA, Elesta S.p.A., Calenzano, Italy) as a treatment for benign prostatic hyperplasia (BPH) and prostate cancer (PCa) using the Delphi consensus method. Methods: Italian and international experts on BPH and PCa participated in a collaborative consensus project. During two rounds, they expressed their opinions on Echolaser® TPLA for the treatment of BPH and PCa answering online questionnaires on indications, methodology, and potential complications of this technology. Level of agreement or disagreement to reach consensus was set at 75%. If the consensus was not achieved, questions were modified after each round. A final round was performed during an online meeting, in which results were discussed and finalized. Results: Thirty-two out of forty invited experts participated and consensus was reached on all topics. Agreement was achieved on recommending Echolaser® TPLA as a treatment of BPH in patients with ample range of prostate volume, from <40 mL (80%) to >80 mL (80%), comorbidities (100%), antiplatelet or anticoagulant treatment (96%), indwelling catheter (77%), and strong will of preserving ejaculatory function (100%). Majority of respondents agreed that Echolaser® TPLA is a potential option for the treatment of localized PCa (78%) and recommended it for low-risk PCa (90%). During the final round, experts concluded that it can be used for intermediate-risk PCa and it should be proposed as an effective alternative to radical prostatectomy for patients with strong will of avoiding urinary incontinence and sexual dysfunction. Almost all participants agreed that the transperineal approach of this organ-sparing technique is safer than transrectal and transurethral approaches typical of other techniques (97% of agreement among experts). Pre-procedural assessment, technical aspects, post-procedural catheterization, pharmacological therapy, and expected outcomes were discussed, leading to statements and recommendations. Conclusion: Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.

Treatment of Spinal Aneurysmal Bone Cyst with Percutaneous Injection of Hydroxyapatite Osteoconductive Cement.

PURPOSE: The aim of this study was to evaluate treatment efficacy of percutaneous injection of hydroxyapatite-osteoconductive-cement in patients with spinal aneurysmal bone cysts. MATERIALS AND METHODS: The study was designed as a retrospective observational clinical study. We included patients who were diagnosed with of spinal aneurysmal bone cyst, at our institution between 2013 and 2020, and treated with percutaneous injection of osteoconductive cement: "Cerament"® (BONESUPPORT AB, Lund, Sweden). Typical clinical and radiological features of the ABCs treatment and follow-up were investigated. RESULTS: Our study included nine patients, two children and seven adults. Three different types of approaches were applied: (single pedicle approach in 3 patients; double pedicle approach in 2 patients; while in the remaining cases, a multiple access approach was used. VAS score decreased from 8.5 ± 0.5 before treatment to 4.1 ± 0.9 at 6-months-follow up. All of the patients reacted well to treatment, with none neurological complications, complete loss of pain and achieved osteosclerosis as radiological marker of treatment success. CONCLUSION: Treatment of symptomatic spinal ABC's with hydroxyapatite cement is effective to achieve complete pain reduction and sclerosis.

Conventional and Advanced MRI Techniques in the Evaluation of Primary CNS Lymphoma.

Primary central nervous system lymphoma (PCNSL) is a rare form of extranodal non-Hodgkin's lymphoma that accounts for 1%-5% of all central nervous system tumors. Contrast-enhanced MR is the imaging technique of choice. PCNLs have a predilection for the periventricular and superficial regions, often abutting the ventricular or meningeal surfaces. Although PCNLs may have characteristic imaging features on conventional MRI, none of these will unequivocally differentiate PCNSLs from other brain lesions. Diffusion restriction, relative hypoperfusion, increased choline/creatinine, decrease of N-acetyl aspartate (NAA) peak as well as the presence of lactate and lipid peaks are consistent advanced imaging findings in CNS lymphoma that may help in the differentiation of Primary central nervous system lymphomas (PCNSLs) from other malignancies. Furthermore, advanced imaging techniques will presumably play an important role in the planning of new targeted therapies, for prognostication, and for the monitoring of treatment response in the future.

Gastrointestinal Stromal Tumors: Diagnosis, Follow-up and Role of Radiomics in a Single Center Experience.

Gastrointestinal stromal tumors (GISTs) arise from the interstitial cells of Cajal in the gastrointestinal tract and are the most common intestinal tumors. Usually GISTs are asymptomatic, especially small tumors that may not cause any symptoms and may be found accidentally on abdominal CT scans. Discovering of inhibitor of receptor tyrosine kinases has changed the outcome of patients with high-risk GISTs. This paper will focus on the role of imaging in diagnosis, characterization and follow-up. We shall also report our local experience in radiomics evaluation of GISTs.

Accuracy of computed tomography in staging acute appendicitis and its impact on surgical outcome and strategy: a multi-center retrospective case-control study.

INTRODUCTION: The aims of this study were to evaluate the concordance between AAST-CT appendicitis grading criteria, first published in 2014, and surgical findings and to assess the impact of CT staging on the choice of surgical approach. METHODS: This was a multi-center retrospective case-control study including 232 consecutive patients undergoing surgery for acute appendicitis and who had undergone preoperative CT evaluation between 1 January 2017 and 1 January 2022. Appendicitis severity was classified in 5 grades. For each degree of severity, the surgical outcome between patients undergoing open and surgical approach was compared. RESULTS: An almost perfect agreement (k = 0.96) was found between CT and surgery in staging acute appendicitis. The vast majority of patients with grade 1 and 2 appendicitis underwent laparoscopic surgical approach and showed low morbidity rate. In patients with grade 3 and 4 appendicitis, laparoscopic approach was adopted in 70% of cases and was associated, if compared to open, with a higher prevalence of postoperative abdominal collections (p = 0.05; fisher's exact test) and a significantly lower prevalence of surgical site infections (p = 0.0007; fisher's exact test). All the patients with grade 5 appendicitis were treated by laparotomy. CONCLUSIONS: AAST-CT appendicitis grading system seems to show a relevant prognostic value and a potential impact on the choice of surgical strategy, directing toward a laparoscopic approach in patients with grade 1 and 2, an initial laparoscopic approach, replaceable by the open one, for grade 3 and 4 and an open approach in patients with grade 5.

The impact of lymphovascular invasion in patients treated with radical nephroureterectomy for upper tract urothelial carcinoma: An extensive updated systematic review and meta-analysis.

Patients with upper tract urothelial carcinoma (UTUC) often have a delayed diagnosis and by then, present with advanced disease which has been shown to be associated with lymphovascular invasion (LVI). It has been suggested to be involved in the metastatic cascade of the disease. In this review, we provide an extensive up-to-date summary of the current knowledge about the prognostic impact of LVI in patients undergoing radical nephroureterectomy (RNU). A systematic search of PubMed/MEDLINE, Scopus, EMBASE, and Web of Science for all reports published from 2010 through 2021 was performed. We performed pooled analyses of hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) of series that evaluated LVI as a prognostic factor in adults with UTUC who underwent RNU. The assessed oncological outcomes were disease recurrence, cancer-specific and overall survival. A meta-regression analysis was used to explore potential heterogeneity. A total of 58 series met the eligibility criteria for qualitative and quantitative synthesis. We included 29,829 patients, ranging from 101 to 2492 per study. All series were retrospective. LVI was present in 7,818 patients (26.2%). The median age of the patients was 69 years and the median follow-up was 40 months. In 40 of 58 studies (68.9%), adjuvant chemotherapy was given. The pooled HRs show that LVI predicts a greater risk of recurrence of the disease (pooled HR 1.43, 95% CI: 1.31-1.55, P = 0.000; I2 = 76.3%), and decreases cancer-specific survival (pooled HR 1.53, 95% CI: 1.41-1.66, P = 0.000; I2 = 72.3%) and overall survival (HR 1.56, 95% CI 1.45-1.69, P = 0.000; I2 = 62.9%). It can be concluded that LVI is a common histologic pattern in surgical specimen in patients undergoing RNU for UTUC. LVI predicts a greater risk of recurrence and mortality, thus it should be carefully assessed in clinical practice to determine prognosis, and for optimal decision-making within the concept of personalized therapies.

Four-year follow-up in 33 patients after inguinal hernioplasty using the NeT Plug & Patch device.

AIM: To prove that the Net Plug & Patch is a valid device for the surgical treatment of inguinal hernia. MATERIAL OF STUDY: The authors of a previous study decided to continue the follow-up for a further three years on 33 patients who had had hernia repair surgery using the three-dimensional NeT Plug & Patch device at their Hernia Center. RESULTS: All of the patients involved took part and the follow-up appointments were scheduled as follows: clinical examination at two years; telephone contact at three years and telephone contact and questionnaire at four years. No symptoms were observed at the second, third and fourth year follow-up time-points. There were no cases of recurrence. DISCUSSION: The Lichtenstein technique is currently considered the gold standard. However, many surgeons now prefer to use the MPR (Mesh Plug Repair) technique, despite the potential complications of using a plug. The technique had a short learning curve with no complications associated directly with the plug used such as migration or possible erosion of the adjacent hollow abdominal organs or blood vessels. CONCLUSIONS: the NeT Plug & Patch device thus proved to be comfortable, safe and efficacious in inguinal repair surgery using the MPR technique. KEY WORDS: Mesh Plug Repair (MPR), Plug migration, Trabucco repair.

Rotterdam mobile phone app including MRI data for the prediction of prostate cancer: A multicenter external validation.

OBJECTIVES: The Rotterdam Prostate Cancer Risk calculator (RPCRC) has been validated in the past years. Recently a new version including multiparametric magnetic resonance imaging (mpMRI) data has been released. The aim of our study was to analyze the performance of the mpMRI RPCRC app. METHODS: A series of men undergoing prostate biopsies were enrolled in eleven Italian centers. Indications for prostate biopsy included: abnormal Prostate specific antigen levels (PSA>4 ng/ml), abnormal DRE and abnormal mpMRI. Patients' characteristics were recorded. Prostate cancer (PCa) risk and high-grade PCa risk were assessed using the RPCRC app. The performance of the mpMRI RPCRC in the prediction of cancer and high-grade PCa was evaluated using receiver operator characteristics, calibration plots and decision curve analysis. RESULTS: Overall, 580 patients were enrolled: 404/580 (70%) presented PCa and out of them 224/404 (55%) presented high-grade PCa. In the prediction of cancer, the RC presented good discrimination (AUC = 0.74), poor calibration (p = 0.01) and a clinical net benefit in the range of probabilities between 50 and 90% for the prediction of PCa (Fig. 1). In the prediction of high-grade PCa, the RC presented good discrimination (AUC = 0.79), good calibration (p = 0.48) and a clinical net benefit in the range of probabilities between 20 and 80% (Fig. 1). CONCLUSIONS: The Rotterdam prostate cancer risk App accurately predicts the risk of PCa and particularly high-grade cancer. The clinical net benefit is wide for high-grade cancer and therefore its implementation in clinical practice should be encouraged. Further studies should assess its definitive role in clinical practice.

Impact of Smoking Habit on Perioperative Morbidity in Patients Treated with Radical Cystectomy for Urothelial Bladder Cancer: A Systematic Review and Meta-analysis.

CONTEXT: Smoking habit at the time of surgery is associated with higher perioperative complications and mortality across different types of surgeries. In recent years, several studies have attempted to explore the influence of smoking on perioperative outcomes following radical cystectomy (RC) for urothelial bladder cancer (UBC) with contradictory results. OBJECTIVE: To systematically investigate and meta-analyze the association between smoking habit and perioperative morbidity and mortality in UBC patients treated with RC. EVIDENCE ACQUISITION: A systematic review of the literature published between January 2000 and January 2020 investigating the impact of smoking habit on perioperative outcomes of patients treated with RC for UBC was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement and the Cochrane Handbook for Systematic Reviews of Interventions. EVIDENCE SYNTHESIS: Overall, 27 articles involving 27 854 patients were included in the systematic review, and of these, 11 studies were included in the meta-analysis. The studies included showed a moderate to high risk of bias. Smoking status (smokers vs nonsmokers) was significantly associated with the onset of major postoperative complications (hazard ratio [HR] 1.87, 95% confidence interval [CI] 1.51-2.32; I2 = 0%), infections (HR 1.34, 95% CI 1.02-1.72; I2 = 66.2%), and mortality (HR 1.84, 95% CI 1.14-2.98; I2 = 4.9%). CONCLUSIONS: Smoking status at the time of RC is associated with increased risk for major postoperative complications, infections, and mortality. These results suggest the need for strict postoperative monitoring in smokers due to the increased risk of experiencing adverse events and underline the need for intensive smoking cessation interventions in the preoperative setting. PATIENT SUMMARY: In this study, we reviewed the impact of smoking habit on perioperative outcomes following radical cystectomy (RC). Based on the available data, the impact of smoking on morbidity and mortality after RC is significant and relevant; as such, every effort should be made in the preoperative setting to encourage smoking cessation.

How far is too far? Exploring the indications for robotic partial nephrectomy in a highly complex kidney tumor

ABSTRACT Purpose: The conservative management of localized renal masses has been recently widened to cT2 tumors showing encouraging functional and oncological outcomes (1). This video aims to report the conservative management of a highly complex renal tumor treated with robotic pure enucleation in our center, specifically focusing on preoperative work-up, video-reported surgical steps and perioperative outcomes. Materials and Methods: A 63 year-old lady underwent CT scan revealing a single 75 x 68mm, mainly endophytic, right renal mass dislocating the vascular pedicle (cT3a). Two renal arteries and two veins were identified. PADUA, RENAL and simplified SPARE scores were 14a, 12a and 12 respectively. Since the contralateral kidney was hypotrophic, the indication for nephron-sparing approach was considered absolute. Preoperative surgical planning included the employment of 3D-virtual models (2). Results: Operative time was 150 minutes and warm ischemia time was 25 minutes. No major complication occurred. Histopathological analysis revealed a cromophobe renal cell carcinoma with extension to perirenal fat tissue (pT3a). Resection technique was classified as pure enucleation since Surface-Intermediate-Base (SIB) score was 0-0-0 (3, 4). At seven-months follow-up no signs of local or systemic recurrence were recorded. Postoperative CT-scan revealed optimal parenchymal volume preservation with last creatinine blood level of 1.16mg/dL. Conclusion: This video highlights how, in experienced hands, robotic partial nephrectomy represents a feasible, effective treatment option for surgical management of highly complex renal tumors. The employment of intraoperative ultrasonography and 3D-virtual models allowed to accurately tailor surgical approach, improving the perception of tumor anatomy and its vascularization and maximizing perioperative outcomes.

Active treatment of renal stones in pelvic ectopic kidney: systematic review of literature.

INTRODUCTION: Chronic obstruction and stones formation are common in pelvic ectopic kidney (PEK), and stone treatment in such conditions can be challenging. Aim of this systematic review was to examine all the available active treatment modalities for PEK stones in order to critically appraise their advantages and limitations. EVIDENCE ACQUISITION: A search on Medline, Embase, and the Cochrane Library databases was performed to identify literature focused on the active treatment of PEK stones. Original articles, case report and case series were included in the search. The systematic review was conducted in accordance to the PRISMA checklist. The study period went from inception of databases to October 2019. EVIDENCE SYNTHESIS: Of the 256 articles identified, 23 met the inclusion criteria. 334 patients were included in the studies and 119 had stones in PEK. Five patients were treated with SWL, 40 with ureterorenoscopy, 37 with percutaneous nephrolithotomy both by ultrasound/X-Ray or lap-assisted puncture, and 37 with minimally invasive laparoscopic or robot assisted pyelolithotomy. Overall, stone free rate after first treatment was higher in minimally invasive laparoscopic or robot assisted pyelolithotomy (97.2%) compared to percutaneous nephrolithotomy (84.96%) and ureterorenoscopy studies (65.94%). The higher complication rate was reported in percutaneous nephrolithotomy not lap-assisted (33.3%). CONCLUSIONS: The choice of the approach depends on different factors such as stone size, density and location in accordance with upper urinary tract alterations, kidney anatomy and operator experience. The choice of a retrograde, percutaneous or lap/robot approach should be carefully selected evaluating upper urinary tract anatomy and stone features.

En-bloc endoscopic enucleation of the prostate: a systematic review of the literature.

INTRODUCTION: Transurethral resection of the prostate (TURP) remains the gold standard for treatment of benign prostatic hyperplasia (BPH). Yet, the introduction of lasers for the treatment of LUTS due to BPO has dramatically changed the surgical landscape of benign prostatic obstruction (BPO) treatment. Recently, "en-bloc" techniques have shown to prove advantageous in terms of better visualization, more prompt identification of the surgical capsule and the correct plane to dissect. Herein we provide a comprehensive overview of available series of en-bloc enucleation of the prostate, focusing on surgical techniques, perioperative and functional outcomes. EVIDENCE ACQUISITION: A systematic review of the literature was performed according to PRISMA recommendations and was conducted on surgical techniques and perioperative outcomes of minimally invasive en-bloc surgery for prostate adenoma detachment. EVIDENCE SYNTHESIS: Overall, 16 studies with 2750 patients between 2003 and 2019 were included. Specific technical nuances have been described to maximize perioperative outcomes of en-bloc prostatic enucleation, including early apical release, horse-shape incisions, inverted U-shape tractions and low power. Overall, regardless of the energy employed, en-bloc prostatic enucleation achieved favorable outcomes including low risk of major complications and quality of life improvement. However, a great heterogeneity of study design, patients' inclusion criteria, prostate volume and en-bloc surgical strategy was found. CONCLUSIONS: En-bloc endoscopic enucleation of the prostate has been shown to be technically feasible and safe, with potential technical advantages over the classic three-lobe technique. Larger comparative studies are needed to evaluate the ultimate impact of the en-bloc approach on postoperative outcomes, in light of the surgeon's learning curve.

External validation of Cormio nomogram for predicting all prostate cancers and clinically significant prostate cancers.

PURPOSE: Recently, the Cormio et al. nomogram has been developed to predict prostate cancer (PCa) and clinically significant PCa using benign prostatic obstruction parameters. The aim of the present study was to externally validate the nomogram in a multicentric cohort. METHODS: Between 2013 and 2019, patients scheduled for ultrasound-guided prostate biopsy were prospectively enrolled at 11 Italian institutions. Demographic, clinical and histological data were collected and analysed. Discrimination and calibration of Cormio nomogram were assessed with the receiver operator characteristics (ROC) curve and calibration plots. The clinical net benefit of the nomogram was assessed with decision curve analysis. Clinically significant PCa was defined as ISUP grade group > 1. RESULTS: After accounting for inclusion criteria, 1377 patients were analysed. 816/1377 (59%) had cancer at final pathology (574/816, 70%, clinically significant PCa). Multivariable analysis showed age, prostate volume, DRE and post-voided residual volume as independent predictors of any PCa. Discrimination of the nomogram for cancer was 0.70 on ROC analysis. Calibration of the nomogram was excellent (p = 0.94) and the nomogram presented a net benefit in the 40-80% range of probabilities. Multivariable analysis for predictors of clinically significant PCa found age, PSA, prostate volume and DRE as independent variables. Discrimination of the nomogram was 0.73. Calibration was poor (p = 0.001) and the nomogram presented a net benefit in the 25-75% range of probabilities. CONCLUSION: We confirmed that the Cormio nomogram can be used to predict the risk of PCa in patients at increased risk. Implementation of the nomogram in clinical practice will better define its role in the patient's counselling before prostate biopsy.

Oncological impact of inflammatory biomarkers in elderly patients treated with radical cystectomy for urothelial bladder cancer.

OBJECTIVE: To evaluate the impact of preoperative markers of systemic inflammation on complications and oncological outcomes in patients aged ≥75 years treated with radical cystectomy (RC) for urothelial bladder cancer (UBC). PATIENTS AND METHODS: The clinical data of 694 patients treated with open RC for UBC at our institution between January 2008 and December 2015 were retrospectively reviewed. Patients aged <75 years, with distant metastases, other-than-urothelial histological type, comorbidities that could affect the systemic inflammatory markers, and patients who received neoadjuvant chemotherapy were excluded. Multivariable regression models were built for the prediction of major postoperative surgical complications, disease recurrence, cancer-specific mortality (CSM), and overall mortality (OM). RESULTS: The median (interquartile range [IQR]) age at surgery was 79 (75-83) years. Major postoperative surgical complications were registered in 41.9% of the patients. The 5-year overall survival, cancer-specific survival and recurrence-free survival rates were 42.4% (95% confidence interval [CI] 34.7-49.9%), 70.3% (95% CI 62.3-76.9%), and 59.8% (95% CI 52.4-66.5), respectively. At multivariable analysis, higher levels of fibrinogen and a modified Glasgow Prognostic Score (mGPS) of 1 and 2 at baseline were independently associated with higher risk of major postoperative complications and of CSM. The inclusion of mGPS and fibrinogen to a standard multivariable model for recurrence and for CSM increased discrimination from 69.4% to 73.0% and from 71.3% to 73.9%, respectively. Preoperative neutrophil-to-lymphocyte ratio of >3 was independently associated with OM (hazard ratio 1.38, 95% CI 1.01-1.77; P = 0.01). CONCLUSIONS: In a cohort of elderly patients with UBC treated with RC, fibrinogen and mGPS appeared to be the most relevant prognostic measurements and increased the accuracy of clinicopathological preoperative models to predict major postoperative complications, disease recurrence and mortality. ABBREVIATIONS: ASA: American Society of Anesthesiologists; CCI: Charlson Comorbidity Index; CIS: carcinoma in situ; CRP: C-reactive protein; CSM: cancer-specific mortality; CSS: cancer-specific survival; ECOG PS: Eastern Cooperative Oncology Group Performance Status; HDL: high-density lipoprotein; (S)HR: (subdistribution) hazard ratio; LND: lymphadenectomy; LVI: lymphovascular invasion; mGPS: modified Glasgow Prognostic Score; NLR: neutrophil-to-lymphocyte ratio; NOC: non-organ-confined; OM: overall mortality; OR: odds ratio; OS: overall survival; RC: radical cystectomy; RNU: radical nephroureterectomy; UBC: urothelial bladder cancer; UTUC: upper urinary tract urothelial carcinoma.

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

PURPOSE: To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN). METHODS: 302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared. RESULTS: Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008). CONCLUSIONS: The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

Predictors of the Transition from Off to On Clamp Approach during Ongoing Robotic Partial Nephrectomy: Data from the CLOCK Randomized Clinical Trial.

PURPOSE: We sought to identify predictive factors of the transition from off clamp to on clamp robotic partial nephrectomy following an intraoperative decision. MATERIALS AND METHODS: In the multicenter, randomized, prospective CLOCK (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy) trial 152 and 149 of the 301 patients with a localized renal mass were assigned to undergo off clamp and on clamp robotic partial nephrectomy, respectively. Surgery was done at a total of 7 referral institutions by 1 surgeon per institution. A localized renal mass was defined as having a R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior, location relative to polar lines, hilar) score less than 10. Surgeons had similar experience with at least 100 previous robotic partial nephrectomies. All patients underwent a preoperative and a 6-month renal scan. The current study deals with one of the secondary end points of the trial, comparing cases finalized as clampless (off robotic partial nephrectomy group) with those which were converted (shift robotic partial nephrectomy group). RESULTS: Of the 152 patients randomized to off clamp 61 (40%) were shifted to clamp with a median ischemia time of 15 minutes. In the shift robotic partial nephrectomy group the masses were larger (3.5 vs 2.2 cm) and more complex (R.E.N.A.L. score 7 vs 6). A significant association with transition was found for tumor diameter (OR 1.4) and the R.E.N.A.L. score continuously (OR 1.4) and when recoded in groups, including 4-no risk (referent OR 1), 5-6-low risk (OR 1.8), 7-8-intermediate risk (OR 3.6) and 9 or greater-high risk (OR 6.6). The shift robotic partial nephrectomy group had longer operative time, higher blood loss and increased performance of 2-layer renorrhaphy. No significant differences were noted in postoperative complications or renal function after 6 months. CONCLUSIONS: The transition from off to on clamp robotic partial nephrectomy is associated with renal mass diameter and complexity. Under the specific conditions of the current trial no harm was related to this decision.