膀胱前列腺肌重建的机器人辅助前列腺癌根治术患者拔管后尿控恢复及安全性评估:一项前瞻性随机对照试验

Robot-assisted urinary control recovery and safety assessment of vesicoprostatic muscle reconstruction after extubation in patients undergoing radical prostatectomy for prostate cancer:a prospective randomized controlled trial

目的分析膀胱前列腺肌(VPM)重建对机器人辅助前列腺癌根治术(RARP)患者拔管后早期尿控恢复以及安全性的影响。方法选取2021年9月1日—2023年8月31日于苏北人民医院接受RARP的128例患者作为研究对象,采用随机数字表法将患者分为未重建组与重建组,各64例。重建组患者采用Montsouris+VPM重建手术方式,未重建组患者采用Montsouris手术方式。通过电话、门诊随访以及住院病历收集患者尿控情况及围手术期相关数据。使用重叠加权对两组患者进行匹配,并使用Kaplan-Meier方法计算拔管后1、2及3个月的尿失禁情况。对比两组患者拔管后早期(3个月内)尿控恢复率、手术时间、术中估计出血量、切缘阳性率以及术后早期(<30 d)并发症(Clavien-Dindo分级)发生率。结果患者拔管后1、2及3个月的尿控恢复率比较,重建组明显高于未重建组(33.9%vs.11.2%;46.7%vs.16.1%;70.6%vs.45.6%,P<0.05),重建组切缘阳性率低于未重建组(16.1%vs.41.7%,P<0.05)。两组患者的手术时间、术中估计出血量、术后早期并发症发生率差异无统计学意义(P>0.05)。结论VPM重建能够在不增加手术风险的情况下提高RARP患者拔管后早期的尿控恢复率。

Objective To analyze the effects of vesicoprostatic muscle(VPM)reconstruction on the early urinary control recovery and safety of patients undergoing robot-assisted radical prostatectomy(RARP).Methods A total of 128 patients who underwent RARP in our hospital during Sep.1,2021 and Aug.31,2023 were enrolled and divided into the non-reconstruction group(n=64)and reconstruction group(n=64)using random number table method.The reconstruction group received Montsouris+VPM reconstruction surgery,while the non-reconstructive group underwent Montsouris surgery only.Urinary control and perioperative data were collected with telephone interview,outpatient follow-up and inpatient records.The two groups were matched using overlap weighting and the Kaplan-Meier method was used to calculate urinary incontinence rates at 1,2 and 3 months after extubation.Early urinary control(3 months after extubation),operation time,intraoperative bleeding,positive rate of incision margin,and incidence of early postoperative complications(<30 days)(Clavien-Dindo scale)were compared between the two groups.Results The recovery rate of urinary control at 1,2 and 3 months after extubation was significantly higher in the reconstruction group than that in the non-reconstruction group(33.9%vs.11.2%;46.7%vs.16.1%;70.6%vs.45.6%,P<0.05),but the positive rate of resection margin was lower(16.1%vs.41.7%,P<0.05).There were no significant differences in operation time,intraoperative bleeding and early postoperative complications between the two groups(P>0.05).Conclusion VPM reconstruction can improve urinary control recovery in RARP patients early after extubation without increasing the risk of surgery.