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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; NCT 02287987) 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. [ABSTRACT FROM AUTHOR]

Objective: To identify meaningful predictors and to develop a nomogram of postoperative surgical complications in patients treated with partial nephrectomy (PN). Patients and Methods: We prospectively evaluated 4308 consecutive patients who had surgical treatment for renal tumours, between 2013 and 2016, at 26 Italian urological centres (RECORd 2 project). A multivariable logistic regression for surgical complications was performed. A nomogram was created from the multivariable model. Internal validation processes were performed using bootstrapping with 1000 repetitions. Results: Overall, 2584 patients who underwent PN were evaluated for the final analyses. The median (interquartile [IQR]) American Society of Anesthesiologists (ASA) score was 2 (2–3). In all, 72.4% of patients had clinical T1a (cT1a) stage tumours. The median (IQR) Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score was 7 (6–8). Overall, 34.3%, 27.7%, 38% of patients underwent open PN (OPN), laparoscopic PN (LPN), and robot‐assisted PN (RAPN). Overall and major postoperative surgical complications were recorded in 10.2% and 2.5% of patients, respectively. At multivariable analysis, age, ASA score, cT2 vs cT1a stage, PADUA score, preoperative anaemia, OPN and LPN vs RAPN, were significant predictive factors of postoperative surgical complications. We used these variables to construct a nomogram for predicting the risk of postoperative surgical complications. At decision curve analysis, the nomogram led to superior outcomes for any decision associated with a threshold probability of >5%. Conclusion: Several clinical predictors have been associated with postoperative surgical complications after PN. We used this information to develop and internally validate a nomogram to predict such risk. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the ability of original tumour contact surface area (CSA) to predict postoperative complications and renal function impairment in a series of patients who underwent elective partial nephrectomy (PN) for renal masses. Materials and Methods: We analysed the clinical records of 531 consecutive patients who underwent elective PN because of a suspicion of kidney cancer at five academic, high‐volume centres between January 2014 and December 2016. Each participating centre evaluated prospectively the radiological images to evaluate the CSA and to assign a PADUA score. Several expert surgeons performed the surgical procedures in each participating centre. Binary logistic regression was used to perform both univariable and multivariable analyses to identify predictors of postoperative complications. Linear regression analysis was used to identify independent predictors of absolute change in estimated glomerular filtration rate (eGFR; ACE). Results: The median (interquartile range) CSA value was 14.2 (7.4–25.1) cm2. A total of 349 tumours (65.7%) had a CSA ≤ 20 cm2 and the remaining 182 (34.3%) had a CSA > 20 cm2. PNs were performed using an open approach in 237 (44.6%) cases, a pure laparoscopic approach in 152 cases (28.6%), and a robot‐assisted approach in the remaining 142 cases (26.7%). Multivariable analyses found that only age (odds ratio [OR] 1.037, 95% confidence interval [CI] 1.018–1.057) and PADUA score (OR 1.289, 95%CI 1.132–1.469) were independent predictors of postoperative complications. Tumour CSA (OR 1.020, 95%CI 1.010–1.030) was found to be an independent predictor of postoperative complications only when PADUA score was removed from the model. Age (from −0.639 to −0.306; P < 0.001); body mass index (from 0.267 to 1.076; P = 0.001), age‐adjusted Charlson score (from −3.193 to −0.259; P = 0.02), preoperative eGFR value (from −0.939 to −0.862; P < 0.001) and tumour CSA (from −0.260 to −0.048; P = 0.005) were found to be independent predictors of ACE. Conclusions: Tumour CSA is an independent predictor of postoperative renal function. Conversely, at multivariable analysis, PADUA score outperformed tumour CSA to predict postoperative complications after PN. The complexity of The Leslie et al. formula for calculating tumour CSA is a potential limitation with regard to its diffusion and application in clinical practice. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the ability of original tumour contact surface area (CSA) to predict postoperative complications and renal function impairment in a series of patients who underwent elective partial nephrectomy (PN) for renal masses. Materials and Methods: We analysed the clinical records of 531 consecutive patients who underwent elective PN because of a suspicion of kidney cancer at five academic, high‐volume centres between January 2014 and December 2016. Each participating centre evaluated prospectively the radiological images to evaluate the CSA and to assign a PADUA score. Several expert surgeons performed the surgical procedures in each participating centre. Binary logistic regression was used to perform both univariable and multivariable analyses to identify predictors of postoperative complications. Linear regression analysis was used to identify independent predictors of absolute change in estimated glomerular filtration rate (eGFR; ACE). Results: The median (interquartile range) CSA value was 14.2 (7.4–25.1) cm2. A total of 349 tumours (65.7%) had a CSA ≤ 20 cm2 and the remaining 182 (34.3%) had a CSA > 20 cm2. PNs were performed using an open approach in 237 (44.6%) cases, a pure laparoscopic approach in 152 cases (28.6%), and a robot‐assisted approach in the remaining 142 cases (26.7%). Multivariable analyses found that only age (odds ratio [OR] 1.037, 95% confidence interval [CI] 1.018–1.057) and PADUA score (OR 1.289, 95%CI 1.132–1.469) were independent predictors of postoperative complications. Tumour CSA (OR 1.020, 95%CI 1.010–1.030) was found to be an independent predictor of postoperative complications only when PADUA score was removed from the model. Age (from −0.639 to −0.306; P < 0.001); body mass index (from 0.267 to 1.076; P = 0.001), age‐adjusted Charlson score (from −3.193 to −0.259; P = 0.02), preoperative eGFR value (from −0.939 to −0.862; P < 0.001) and tumour CSA (from −0.260 to −0.048; P = 0.005) were found to be independent predictors of ACE. Conclusions: Tumour CSA is an independent predictor of postoperative renal function. Conversely, at multivariable analysis, PADUA score outperformed tumour CSA to predict postoperative complications after PN. The complexity of The Leslie et al. formula for calculating tumour CSA is a potential limitation with regard to its diffusion and application in clinical practice. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the efficacy of hemostatic agents, TachoSil and FloSeal, during partial nephrectomy using a large multicenter dataset. Methods Data of 1055 patients who underwent partial nephrectomy between January 2009 and December 2012 in 19 Italian centers were collected within an observational multicentric study ( RECORd Project). The decision whether or not to use hemostatic agents after renorrhaphy and the type of hemostatic agents applied was adopted according to the centers' and surgeons' preference. A Tri Match propensity score analysis was applied to balance three study groups (no hemostatic agents, TachoSil, FloSeal) for sex, age, surgical indication (elective/relative vs imperative), clinical stage ( cT1a vs cT1b), tumor exophyticity, approach (open vs minimally invasive), technique (standard partial nephrectomy vs simple enucleation), preoperative hemoglobin and creatinine. Postoperative complications and variation of hemoglobin and creatinine values between preoperative versus third postoperative day were compared. Results Tri Match analysis allowed us to obtain 66 well-balanced triplets. No differences were found in terms of outcomes between the study groups. Conclusions The present findings suggest that adding hemostatic agents to renorraphy during partial nephrectomy does not provide better surgical outcomes. [ABSTRACT FROM AUTHOR]