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临床试验/NCT06950216
NCT06950216尚未招募不适用

Intraoperative Neuromonitoring During Radical Prostatectomy

The Fourth Affiliated Hospital of Zhejiang University School of Medicine0 个研究点目标入组 40 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
IIEF-5

研究概览

简要总结

At present, the preferred treatment for patients with prostate cancer is still radical prostatectomy. Postoperative patients often face some complications, the most common complications include urinary incontinence and erectile dysfunction. Urinary incontinence is caused by intraoperative injury of urinary control nerves or muscles. Erectile dysfunction is related to intraoperative injury of nerves that control erection. Therefore, intraoperative nerve preservation is a key measure to reduce postoperative complications, especially to prevent erectile dysfunction. This study intends to improve the nerve-sparing radical prostatectomy by monitoring the nerve during radical prostatectomy, locating the cavernous nerve and other related nerves, in order to reduce the incidence of postoperative complications such as erectile dysfunction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Care Provider)

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

入选标准

  • 1: Prostate cancer patients undergoing surgical treatment in our Hospital 2: Understand the content of this study, actively provide complete and true medical history and examination data, and be willing to cooperate with postoperative interviewers.
  • 3: Voluntarily participate in the study and sign the treatment document within the ethical framework.

排除标准

  • 1: Histopathology showed that the patient did not have prostate cancer 2: Use a cardiac pacemaker or other electromechanical prosthesis device 3: Suffering from a serious neurological disease, mental illness or other illness that may be life-threatening within two years

结局指标

主要结局

IIEF-5

时间窗: 1,3,6 and 12 months after operation

international index of erectile function-5

次要结局

未报告次要终点

研究者

发起方
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

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