机器人辅助根治性前列腺切除术中背侧血管复合体的标准结扎与延迟结扎：一项随机对照试验的结果
Standard vs delayed ligature of the dorsal vascular complex during robot-assisted radical prostatectomy: results from a randomized controlled trial.
作者信息
Antonelli Alessandro, Palumbo Carlotta, Veccia Alessandro, Fisogni Simona, Zamboni Stefania, Furlan Maria, Francavilla Simone, Lattarulo Marco, De Marzo Enrico, Mirabella Giuseppe, Peroni Angelo, Simeone Claudio
机构信息
Department of Urology, Spedali Civili Hospital, University of Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy.
Department of Pathology, Spedali Civili Hospital, University of Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy.
出版信息
J Robot Surg. 2019 Apr;13(2):253-260. doi: 10.1007/s11701-018-0847-9. Epub 2018 Jul 13.
PURPOSE
Prospective randomized trial to compare standard vs delayed approach to dorsal vascular complex (s-DVC vs d-DVC) in robot-assisted radical prostatectomy (RARP).
METHODS
Patients scheduled for RARP were randomized into a 1:1 ratio to receive either s-DVC or d-DVC by two experienced surgeons. In s-DVC arm an eight-shaped single stitch was given at the beginning of the procedure and the DVC was subsequently cut at time of apical dissection; in d-DVC arm the plexus was transected at the end of prostatectomy, prior to apex dissection and then sutured. Primary endpoint was difference in estimated blood loss (EBL) and a sample size of 226 cases was calculated; ad interim analysis was planned after 2/3 of recruitment.
RESULTS
Endpoint was reached at ad interim analysis after 162 cases (81 s-DVC, 81 d-DVC) and recruitment was, therefore, interrupted. Baseline and tumor characteristics were overlapping. EBL was significantly higher in d-DVC arm (mean EBL 107 vs 65 ml, p = 0.003), but without differences in post-operative hemoglobin, transfusions and complications. Overall PSM rate was higher in d-DVC arm (21.0 vs 14.8%, p = 0.323), with statistical significance relatively to organ-confined disease (15.5 vs 3.6%, p = 0.031). Apical involvement was instead significantly higher in s-DVC arm (prevalence in PSM patients 66.7 vs 23.5%, p = 0.020). Post-operative PSA, continence and potency rates were similar between groups.
CONCLUSIONS
Standard and delayed approaches to DVC are safe and lead to similar functional outcomes. A delayed approach exposes to a higher risk of PSM in organ-confined disease but with a lower risk of apical involvement.
目的
在机器人辅助根治性前列腺切除术（RARP）中进行前瞻性随机试验，比较处理背侧血管复合体的标准方法与延迟方法（s-DVC 与 d-DVC）。
方法
计划接受 RARP 的患者按 1:1 比例随机分组，由两位经验丰富的外科医生分别采用 s-DVC 或 d-DVC 方法。在 s-DVC 组，手术开始时采用八字形单缝合法，随后在尖部解剖时切断背侧血管复合体；在 d-DVC 组，在前列腺切除术后、尖部解剖前切断神经丛，然后进行缝合。主要终点是估计失血量（EBL）的差异，计算得出样本量为 226 例；计划在招募 2/3 病例后进行中期分析。
结果
在纳入 162 例患者（81 例 s-DVC，81 例 d-DVC）后进行中期分析时达到终点，因此招募工作中断。基线和肿瘤特征重叠。d-DVC 组的 EBL 显著更高（平均 EBL 为 107 毫升对 65 毫升，p = 0.003），但术后血红蛋白、输血和并发症方面无差异。d-DVC 组的总体阳性手术切缘（PSM）率更高（21.0%对 14.8%，p = 0.323），相对于器官局限性疾病有统计学意义（15.5%对 3.6%，p = 0.031）。相反，s-DVC 组的尖部受累情况显著更高（PSM 患者中的患病率为 66.7%对 23.5%，p = 0.020）。两组之间术后 PSA、控尿和性功能恢复率相似。
结论
处理背侧血管复合体的标准方法和延迟方法都是安全的，且功能结局相似。延迟方法在器官局限性疾病中导致 PSM 的风险更高，但尖部受累风险更低。
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