评估保留神经的机器人辅助前列腺根治术中会阴水分离技术的前瞻性随机对照试验。

A prospective randomized controlled trial for assessment of perineal hydrodissection technique for nervesparing robot assisted radical prostatectomy.

机构信息

Department of Urology, University of Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany.

Department of Medical Biometry, University of Heidelberg, Im Neuenheimer Feld, Heidelberg, Germany.

出版信息

Int J Med Robot. 2017 Dec;13(4). doi: 10.1002/rcs.1835. Epub 2017 May 23.

DOI:10.1002/rcs.1835

PMID:28544071

Abstract

BACKGROUND

This study prospectively evaluated the safety and efficacy of perineal hydrodissection in robot assisted nervesparing prostatectomy.

METHODS

Patients were randomized for perineal, ultrasound guided hydrodissection (HD) before radical prostatectomy and compared with standard treatment (ST). Follow-up was done every 3 months, including erectile function (IIEF5-score), reported grade of erection, ability for sexual intercourse, continence, PSA.

RESULTS

21 patients were enrolled to this prospective study, 10 for ST and 11 for HD. No significant differences in demographic and preoperative oncological data between both groups were identified. Blood loss and time for surgery did not differ significantly. HD resulted in 66% (4/6) rate of positive surgical margins (PSM) in pT3 tumors vs 50% in ST (1/2; P = 0.67). Follow-up revealed higher IIEF scores, better ability for sexual intercourse and early continence in HD.

CONCLUSIONS

Erectile function after radical prostatectomy was improved by perineal hydrodissection in this proof of principal study. However, careful patient selection and further studies are needed as perineal hydrodissection could result in increased positive surgical margins in pT3a tumors.

摘要

背景

本研究前瞻性评估了经会阴超声引导水分离在机器人辅助保留神经前列腺切除术的安全性和有效性。

方法

患者随机分为经会阴组（接受水分离）和标准治疗组（不接受水分离），比较两组患者根治性前列腺切除术后的安全性和疗效。随访每 3 个月进行一次，包括勃起功能（IIEF5 评分）、勃起程度、性交能力、控尿和 PSA。

结果

本前瞻性研究共纳入 21 例患者，其中 10 例接受标准治疗，11 例接受经会阴水分离。两组患者在人口统计学和术前肿瘤学数据方面无显著差异。两组患者的术中出血量和手术时间无显著差异。经会阴水分离组在 pT3 肿瘤中的阳性切缘率为 66%（4/6），标准治疗组为 50%（1/2），两组差异无统计学意义（P=0.67）。随访发现，经会阴水分离组患者的 IIEF 评分更高，性交能力和早期控尿能力更好。