Urology Unit, ASST Spedali Civili Hospital, Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia , Italy.
The Urology Units of D'Annunzio Hospital, University of Chieti , Chieti , Italy.
J Urol. 2019 Jul;202(1):62-68. doi: 10.1097/JU.0000000000000194. Epub 2019 Jun 7.
We sought to identify predictive factors of the transition from off clamp to on clamp robotic partial nephrectomy following an intraoperative decision.
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).
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.
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.
我们旨在确定术中决策后从机器人辅助部分肾切除术的断流夹到夹闭夹的转换的预测因素。
在多中心、随机、前瞻性 CLOCK（机器人辅助部分肾切除术中夹闭与断流夹肾）试验中，301 例局限性肾肿瘤患者中有 152 例和 149 例分别被分配行断流夹和夹闭夹机器人辅助部分肾切除术。手术由每个机构的 1 名外科医生在 7 家转诊机构进行。局限性肾肿瘤的定义为 R.E.N.A.L.（半径、外生性/内生性、靠近集合系统或窦、前/后、相对于极线的位置、 hilar）评分小于 10。外科医生均有至少 100 例机器人辅助部分肾切除术的经验。所有患者均行术前和 6 个月的肾扫描。本研究涉及该试验的次要终点之一，比较最终断流夹（机器人辅助部分肾切除术组）与转换（机器人辅助部分肾切除术组）的病例。
在随机分组至断流夹的 152 例患者中，有 61 例（40%）转为夹闭夹，中位缺血时间为 15 分钟。在机器人辅助部分肾切除术组中，肿瘤较大（3.5 厘米对 2.2 厘米）且更复杂（R.E.N.A.L.评分 7 对 6）。与转换相关的显著因素为肿瘤直径（OR 1.4）和 R.E.N.A.L.评分连续（OR 1.4），当按组记录时，包括 4-无风险（参照 OR 1）、5-6-低风险（OR 1.8）、7-8-中等风险（OR 3.6）和 9 或更高-高风险（OR 6.6）。机器人辅助部分肾切除术组的手术时间较长、失血量较多，2 层肾缝合术的比例较高。术后 6 个月时，两组的并发症或肾功能无显著差异。
从断流夹到夹闭夹机器人辅助部分肾切除术的转换与肾肿瘤的直径和复杂性相关。在当前试验的特定条件下，这一决策没有带来危害。
