Jeong Chang Wook, Lee Jung Keun, Oh Jong Jin, Lee Sangchul, Jeong Seong Jin, Hong Sung Kyu, Byun Seok-Soo, Lee Sang Eun
Department of Urology, Seoul National University Hospital, Seoul, Republic of Korea; Department of Urology, College of Medicine, Seoul National University, Seoul, Republic of Korea.
Department of Urology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
J Urol. 2015 Mar;193(3):935-42. doi: 10.1016/j.juro.2014.10.023. Epub 2014 Oct 12.
We devised a 1-step posterior reconstruction technique that opposes the median dorsal raphe only to the posterior counterpart of the detrusor apron rather than to Denonvilliers' fascia. In a retrospective study we previously found that during robot-assisted laparoscopic prostatectomy this new technique could significantly shorten continence recovery time. We designed a prospective clinical trial to confirm this.
We designed a single-blind, parallel group, randomized, controlled trial. A total of 100 men who underwent robot-assisted laparoscopic prostatectomy performed by a single surgeon at a referral center were randomly allocated to the intervention group (50) or the control group (50) from October 2012 through August 2013. The intervention group underwent posterior reconstruction with this new technique before vesicourethral anastomosis. All patients in each group were treated with anterior reconstruction. The study primary end point was time to continence recovery, defined as no pad use. Secondary outcomes were time to recovery of social continence, defined as 0 or 1 pad used per day.
One control was excluded from analysis due to open conversion and 4 patients were excluded since they withdrew from participation. Median time to complete continence recovery did not differ significantly between the intervention and control groups (106 and 119 days, respectively, p = 0.890). However, time to social continence recovery was significantly shorter in the intervention group than in controls (median 18 vs 30 days, p = 0.024).
One-step posterior reconstruction did not significantly shorten time to complete continence recovery. However, it seemed to have a marginal benefit on early recovery of social continence.
我们设计了一种单步后路重建技术,该技术仅将正中背侧缝与逼尿肌围裙的后部对应部分相对,而不是与Denonvilliers筋膜相对。在一项回顾性研究中,我们之前发现,在机器人辅助腹腔镜前列腺切除术中,这项新技术可显著缩短控尿恢复时间。我们设计了一项前瞻性临床试验来证实这一点。
我们设计了一项单盲、平行组、随机、对照试验。2012年10月至2013年8月,共有100名在转诊中心由一名外科医生进行机器人辅助腹腔镜前列腺切除术的男性被随机分配到干预组(50名)或对照组(50名)。干预组在膀胱尿道吻合术前采用这项新技术进行后路重建。每组所有患者均接受前路重建。研究的主要终点是控尿恢复时间,定义为无需使用尿垫。次要结局是社交控尿恢复时间,定义为每天使用0或1片尿垫。
1名对照组患者因转为开放手术被排除在分析之外,4名患者因退出研究被排除。干预组和对照组之间完全控尿恢复的中位时间无显著差异(分别为106天和119天,p = 0.890)。然而,干预组社交控尿恢复时间明显短于对照组(中位时间分别为18天和30天,p = 0.024)。
单步后路重建并没有显著缩短完全控尿恢复的时间。然而,它似乎对社交控尿的早期恢复有一定益处。