Does the Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? A Multicenter Randomized Controlled Trial. A Phase III Open-label Prospective International Multicenter Randomized Controlled Study for the Evaluation of the Efficacy of PRR, in Patients Subjected to RALP, Measured in Terms of Early Recovery of the Continence.
试验速览
- 阶段
- 3 期
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Urinary continence
研究概览
简要总结
The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 80 years;
- •Biopsy proven clinically localized prostate cancer;
- •Informed consent obtained and signed;
- •Understanding of, and willingness to comply with, the study procedures.
排除标准
- •Pre-operative incontinence;
- •Salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment);
- •Surgical posterior plane at the peri - rectal fat, without preserving an edge of the Denonvilliers;
- •History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements;
研究组 & 干预措施
Standard radical prostectomy
Posterior reconstruction of the musculofascial plate
These patients will receive reconstruction of the muscolofascial plate after radical prostatectomy. The reconstruction will be performed using two 3-0 Poliglecaprone sutures (on RB-1 needles) tied together, with each individual length being 12-15 cm. seven - Ten knots will be placed when tying the sutures to provide a bolster. The free edge of the remaining Denonvillier's fascia will be identified after the prostatectomy and approximated to the posterior aspect of the rhabdosphincter and the posterior median raphe using one arm of the continuous suture. As a rule, four passes will be taken from the right to the left and the suture is locked. The second layer of the reconstruction will be then performed with the other arm of the suture approximating the posterior lip of the bladder neck (full thickness) and the vesicoprostatic muscle to the posterior urethral edge and to the already reconstructed median raphe .This suture will be then tied to the end of the first suture arm.
干预措施: Posterior reconstruction of the rhabdosphincter (Procedure)
结局指标
主要结局
Urinary continence
时间窗: 12 months
No urinary leakages, assessed with the EPIC Questionnaire.
次要结局
- Sexual potency(12 months)
- Oncologic radicality(12 months)
研究者
Bernardo Rocco
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico