The role of vascular clamping during robot-assisted partial nephrectomy for localised renal cancer: rationale and design of the CLOCK randomised phase III study.

The role of vascular clamping during robot-assisted partial nephrectomy for localised renal cancer: rationale and design of the CLOCK randomised phase III study. Minerva Urol Nefrol. 2019 Jan 02;: Authors: Cindolo L, Antonelli A, Sandri M, Annino F, Celia A, De Concilio B, Giommoni V, Nucciotti R, Sessa F, Porreca A, Veccia A, Schips L, Minervini A, AGILE Group (Italian Group for advanced laparo-endoscopic surgery) Abstract Outline the design and rationale of CLOCK, a large, phase III randomised controlled trial which examines the role vascular clamping during robot-assisted partial nephrectomy (RAPN) for localised renal cancer. To be eligible for study entry, patients must have normal coagulative function, preoperative estimated glomerular filtration rate (eGFR) >60 ml/min, normal contralateral kidney and a single renal mass with R.E.N.A.L. score ≤10. Eligible patients are to be randomised in a 1:1 ratio between two arms. Randomized allocation was assigned by a permuted block design, stratified by center. Allocation arm was notified by the study internet-based e-form, managed by an independent software house. Arm A = RAPN with ischemia ; Arm B = RAPN without ischemia At any moment, from randomization to the end of the procedure, the investigators could amend the indication given by randomization and shift to the alternative clamping option, detailing the timing and reasons of their decision. CLOCK is a one of the randomised con...
Source: Minerva Urologica e Nefrologica - Category: Urology & Nephrology Tags: Minerva Urol Nefrol Source Type: research