Extrafascial robotic assisted radical prostatectomy via posterior approachExtrafascial robotic assisted radical prostatectomy via anterior approach
Extrafascial robotic assisted radical prostatectomy via posterior approach: Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.
Extrafascial robotic assisted radical prostatectomy via anterior approach: Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;
2. prostate volume \<80 ml;
3. life expectancy of patients \>10 years;
4. patients sign the "informed consent";
5. 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).
Exclusion Criteria:
1. life expectancy \<10 years;
2. comorbidities with other malignancies;
3. uncorrected coagulation dysfunctions;
4. patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery;
5. patients or family members who did not accept radical prostatectomy.
Primary outcome measure(s)
rate of continence — 1 week after postoperative removal of the urinary catheter rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
voiding score — through study completion, an average of 1 year according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint
erectile function score — through study completion, an average of 1 year according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint
Trial sites (1)
Facility
City
Region
Status
first hospital affiliated of Fujian medical university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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