Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients: a Prospective, Multicenter, Double-blind, Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;

• prostate volume \<80 ml;

• life expectancy of patients \>10 years;

• patients sign the informed consent;

• Routine preoperative examination has been improved (chest CT, electrocardiogram, and color Doppler echocardiography), and there is no serious basic disease. After clinical evaluation, it can tolerance robot-assisted radical prostatectomy (RARP).

Locations
Other Locations
China
first hospital affiliated of Fujian medical university
RECRUITING
Fuzhou
Contact Information
Primary
Ning Xu, Dr.
drxun@fjmu.edu.cn
13235907575
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 118
Treatments
Experimental: the posterior approach extrafascial technique group
In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP.
Active_comparator: the anterior approach extrafascial technique group
Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy.
Related Therapeutic Areas
Sponsors
Collaborators: Zhongshan Hospital Xiamen University, The First Affiliated Hospital of Nanchang University, Hainan People's Hospital, Zhejiang University, Fuzhou General Hospital, Huashan Hospital, Ningbo No. 1 Hospital, The First Hospital of Jilin University, Fujian Cancer Hospital, Second Affiliated Hospital of Third Military Medical University, Longyan City First Hospital
Leads: Ning Xu

This content was sourced from clinicaltrials.gov