Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete recovery of urinary continence
研究概览
简要总结
Incontinence is one of the most common complications of radical prostatectomy. The continence rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP). However, some reports suggested that posterior reconstruction (PR) behind vesicourethral anastomosis could improve early recovery of continence during open, laparoscopic or robot-assisted radical prostatectomy.
But, recent prospective studies reported no benefit of PR after RALP, which was the opposite result of those of previous studies. However the PR techniques used in these prospective studies seem to be quite different from the previous techniques. They seem to have used single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder neck.
Our group identified this anatomic structure as the posterior counterpart of the detrusor apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step reconstruction between MDFR and PDA could be enough for PR. We previously investigated whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would improve continence recovery compared with the standard RALP technique without PR. And our retrospective study demonstrated that this new PR technique during RALP significantly shortens the time to the recovery of continence compared with the standard technique, which does not incorporate PR (Int J Urol, 2012;19:683-7).
Thus, we plan to validate this result by a well-designed, prospective, randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •pathologically proven localized prostate cancer (≤cT3a)
- •patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon (Sang Eun Lee)
排除标准
- •prior hormone therapy
- •prior radiation treatment on prostate or pelvis
- •preoperative urinary incontinence
- •refused to participate
研究组 & 干预措施
Posterior reconstruction
- New posterior reconstruction, which entails opposition of the median dorsal fibrous raphe solely to the posterior counterpart of the detrusor apron
- Vesicourethral anastomosis using the van Velthoven method
- Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex
干预措施: Posterior reconstruction (Procedure)
No posterior reconstruction
- No posterior reconstruction
- Vesicourethral anastomosis using the van Velthoven method
- Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex
结局指标
主要结局
Complete recovery of urinary continence
时间窗: 6 months
Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.
次要结局
- Complication(6 months)
- Self perception (QoL) of urinary function at 3 months(3 months)
- Total operative time(At the day of surgery)
- Estimated blood loss(At the day of surgery)
- Duration of social continence recovery(6 months)
- Continence score at 3 months(3 months)
- Urinary leak at 3 months(3 months)
研究者
Sang Eun Lee
Professor
Seoul National University Bundang Hospital