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临床试验/NCT02687308
NCT02687308已完成不适用

Open Retropubic Radical Prostatectomy With Anterograde Anatomical Dissection Technique (RRP2A), Compared With Walsh Open Anatomical Retrograde Radical Prostatectomy (RRP)

Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
2
主要终点
Surgical time for completed prostatectomy

研究概览

简要总结

Prospective randomized study performing open anterograde anatomical radical retropubic prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by the Pasadena consensus for the procedure assisted by robot, compared with the anatomical radical prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown benefits in the minimally invasive surgical techniques approaches, laparoscopic radical prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These minimally invasive techniques were associated with advantages in complications, like intraoperative bleeding, transfusion rates and in earlier recovery of important genitourinary functions such as urinary continence and penile erection. But still has not been demonstrated conclusively advantages as oncological control and it is believed that there are about 200 to 250 cases of learning curve so that the rates of complications and positive surgical margins become stable and similar to the open radical prostatectomy. These facts associated with the high cost of robotic technology still have limited the generalization of this approach in many developing countries such as Brazil. While the majority of studies made by comparing the radical prostatectomy (RP), robot X laparoscopic X open, show a slight advantage in the first two, there is a significant bias in these studies, which is that the surgical technique used in each procedure differs significantly from minimally invasive and open surgical techniques. The evolution of minimally invasive radical prostatectomy was based on an entirely different anatomical benchmark of that described by Patrick Walsh. While robotics and laparoscopic techniques dissect the prostate, bladder neck and the neurovascular bundle in an antegrade way, from bladder neck to the apex, the Walsh RRP technique is completely different in several ways, the dissection is made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia, is always included with the specimen, and urethrovesical anastomosis, usually performed with multifilament interrupted suture, only for indicating the major differences. The RRP2A will be performed by incision (open surgery) and will be compared with the anatomical radical prostatectomy technique described by Patrick Walsh RRP, and performed by the same surgeons.

详细描述

Introduction The best way to treat localized prostate cancer is radical prostatectomy (RP). This surgery has been performed since 1905, introduced by Young. Initial results were disappointing due to high rates of bleeding, incontinence, impotence and other surgical complications. It was from the knowledge of the anatomical basis of vascularization and innervation of male pelvis by Patrick Walsh that the radical retropubic prostatectomy (RRP) had its development and has become the first choice in the treatment of initial stages of prostate cancer.

Large series of literature results show excellent long-term cancer control, with about 80% of patients with no evidence of disease (biochemical or clinical) in 10 years.

Urinary incontinence rates after RRP vary widely, those regarding absence of the urinary incontinence after 18 months of surgery are uniform in presenting continence rates above 90%. However the continence rates over the short term are much lower.

The definition of recovery of sexual function after surgery is the ability to keep satisfactory sexual intercourse with or without the use of oral drugs. The key factors for the recovery of erectile capacity power prior to surgery are the patient's age and the surgical technique employed. Academic series of open RRP report recovery rates of about 70% with bilateral preservation of nerves, and about 50% with unilateral preservation after 18 months.

Recent studies have shown benefits in the minimally invasive approaches, laparoscopic radical prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP), with respect to complications like intraoperative bleeding, but still do not demonstrate conclusively advantages as oncological control. However the recovery of erectile function and urinary continence seems to recover better and earlier. It is believed that there are about 200-250 cases of learning curve to reach levels that the rates of complications and positive surgical margins become stable and similar to the open radical prostatectomy, and the high cost of robotic technology still has limited the generalization of this approach in many countries.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 40 years or older and willing and able to provide informed consent;
  • Histologically and clinically confirmed localized adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  • Surgical indication for open radical prostatectomy;
  • PSA less than 20 ng/mL;
  • No evidence of metastasis disease;
  • Cleared by the primary medical doctor for surgery;
  • No prior systemic therapy for prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

排除标准

  • Refuses to give informed consent;
  • Refuses or is unable to have radical prostatectomy;
  • Deemed a poor surgical risk per primary medical doctor;
  • Received prior therapeutic intervention for prostate cancer;
  • Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months;
  • Neurogenic bladder;
  • Urinary incontinence.

研究组 & 干预措施

1Retrograde radical prostatectomy RRP

Active Comparator

This opem surgical prostatectomy techniques described by Patrick Walsh is made through prostatic dissection, from apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia is always included with the specimen, and urethrovesical anastomosis usually performed with multifilament interrupted suture

干预措施: 1 Retrograde radical prostatectomy RRP (Procedure)

2Anterograde radical prostatectomy RRP2A

Experimental

This opem surgical prostatectomy techniques dissect the prostate, bladder neck and the neurovascular bundle, in an antegrade way, from bladder neck to the apex. With careful bladder neck dissection and preservation, careful nervesparing procedures with meticulous retroprostatic dissection of the posterior layer of Denonvilliers' fascia, and urethrovesical anastomosis performed through a monofilament running suture.

干预措施: 2 Anterograde radical prostatectomy RRP2A (Procedure)

结局指标

主要结局

Surgical time for completed prostatectomy

时间窗: Day of surgery

Measurement of time for completed surgery. The median operative duration will be measured in minutes and compared between the two techniques

次要结局

  • PSA(One year)
  • Time of urinary catheter(Three months)
  • Time of urethrovesical anastomosis(Day of surgery)
  • Positive surgical margins(Three months)
  • Urinary Continence(One year)
  • Erectile function(One year)
  • Hospital length of stay(One month)
  • Surgical complication(Three months postsurgery)
  • Postoperative complications(One year)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabricio Borges Carrerette

Professor

Rio de Janeiro State University

研究点 (2)

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