Division of Urology, Department of Oncology, San Luigi Gonzaga Hospital, Orbassano (Turin), Italy.
Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, Orbassano (Turin), Italy.
BJU Int. 2019 Mar;123(3):465-473. doi: 10.1111/bju.14583. Epub 2018 Nov 1.
To evaluate the 1-year efficacy of chitosan membrane (ChiMe) application on the neurovascular bundles (NVBs) after nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) in potency recovery rate. To compare the results with those of a contemporary cohort of patients who did not benefit from chitosan use.
Patients in the ChiMe group were enrolled at our institution from July 2015 to September 2016 in a preliminary phase II study. All of them underwent NS-RARP with ChiMe applied on the NVBs and were followed over time to complete a 1-year follow-up. The control group was composed of patients who underwent NS-RARP at our institution without the application of ChiMe from January 2015. The patients were further classified into two groups based on the amount of nerves spared: Group A, comprised patients who underwent a monolateral or bilateral full NS; Group B, comprised patients in which a full NS was not performed. The demographics, peri- and postoperative data, and complications were recorded and compared. Potency recovery was recorded for Group A vs Group B in both the ChiMe and the control groups.
In all, 136 patients were enrolled in the ChiMe group and 334 patients in the control group. There were no differences between groups in terms of baseline variables. Based on the amount of nerves preserved, 183 patients were included in Group A and 287 in Group B. Odds ratios at different time points showed that the only two factors influencing potency recovery were the amount of nerves preserved (Group A vs Group B) and the application or not of ChiMe on the NVBs spared. Comparing the ChiMe vs control groups at different time points, we found a statistically significant improvement in the potency recovery rate in the ChiMe group at 1 month (36.76% vs 25.88%; P = 0.02) and 2 months (52.2% vs 39.22%; P = 0.01) after surgery, showing a favourable trend at every time point of the entire follow-up period, even if not significant after the second postoperative month. In Group A, the log-rank test showed a statistically significant difference between the ChiMe vs control groups (P = 0.02), in particular at 1 and 2 months after surgery (P = 0.02 and P = 0.01, respectively).
The application of ChiMe on the NVBs resulted in a higher potency recovery rate at 1 and 2 months after a bilateral or monolateral full NS-RARP. A trend of a higher and shorter potency recovery rate showed it to be favourable to use ChiMe, even in the cohort of patients who did not undergo a full NS procedure.
评估壳聚糖膜（ChiMe）在神经血管束（NVB）上的应用在神经保留机器人辅助根治性前列腺切除术（NS-RARP）后 1 年内对勃起功能恢复率的影响。并与未使用壳聚糖的同期患者队列的结果进行比较。
ChiMe 组患者于 2015 年 7 月至 2016 年 9 月在我院参加初步的 II 期研究。所有患者均接受 NS-RARP 治疗，同时在 NVB 上应用 ChiMe，并随访 1 年。对照组由 2015 年 1 月在我院接受 NS-RARP 治疗且未使用 ChiMe 的患者组成。根据保留的神经数量，进一步将患者分为两组：A 组，单侧或双侧全 NS；B 组，未行全 NS。记录并比较患者的人口统计学、围手术期和术后数据以及并发症。比较 ChiMe 组和对照组中 A 组与 B 组的勃起功能恢复情况。
共有 136 例患者纳入 ChiMe 组，334 例患者纳入对照组。两组患者的基线变量无差异。根据保留的神经数量，183 例患者纳入 A 组，287 例患者纳入 B 组。不同时间点的优势比表明，唯一影响勃起功能恢复的两个因素是保留的神经数量（A 组与 B 组）和 NVB 上是否应用 ChiMe。比较 ChiMe 组与对照组在不同时间点的勃起功能恢复率，发现 ChiMe 组在术后 1 个月（36.76%比 25.88%；P=0.02）和 2 个月（52.2%比 39.22%；P=0.01）时勃起功能恢复率有统计学意义的改善，在整个随访期间的每个时间点均显示出有利的趋势，尽管在术后第二个月后无统计学意义。在 A 组中，对数秩检验显示 ChiMe 组与对照组之间有统计学意义的差异（P=0.02），尤其是在术后 1 个月和 2 个月（P=0.02 和 P=0.01）。
在双侧或单侧全 NS-RARP 后 1 个月和 2 个月时，在 NVB 上应用 ChiMe 可提高勃起功能恢复率。较高和较短的勃起功能恢复率表明使用 ChiMe 是有利的，即使在未行全 NS 手术的患者中也是如此。
