To compare the functional outcomes of on-vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT). Materials and MethodsThe 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. ResultsA 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. ConclusionIn patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on-vs off-clamp RAPN.

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The study will provide information on patients' quality of life and its variations over time in relation to the treatments received for the prostate cancer.

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The treatment of ureteral strictures represents a challenge due to the variability of aetiology, site and extension of the stricture; it ranges from an end-to-end anastomosis or reimplantation into the bladder with a Boari flap or Psoas Hitch. Traditionally, these procedures have been done using an open access, but minimally invasive approaches have gained acceptance. The aim of this study is to evaluate the safety and feasibility and perioperative results of minimally invasive surgery for the treatment of ureteral stenosis with a long-term follow-up. Data of 62 laparoscopic (n = 36) and robotic (n = 26) treatments for ureteral stenosis in 9 Italian centers were reviewed. Patients were followed according to the referring center's protocol. Laparoscopic and robotic approaches were compared. All the procedures were completed successfully without open conversion. Average estimated blood loss in the two groups was 91.2 ± 71.9 cc for the laparoscopic and 47.2 ± 32.3 cc for the robotic, respectively (p = 0.004). Mean days of hospitalization were 5.9 ± 2.4 for the laparoscopic group and 7.6 ± 3.4 for the robotic group (p = 0.006).No differences were found in terms of operative time and post-operative complications. After a median followup of 27 months, the robotic group yielded 2 stenosis recurrence, instead the laparoscopic group shows no cases of recurrence (p = 0.091). Minimally invasive approach for ureteral stenosis is safe and feasible. Both robotic and pure laparoscopic approaches may offer good results in terms of perioperative outcomes, low incidence of complications and recurrence.