Prostate cancer
Conditions
Interventions
Single-Port Group:Single-Port Extraperitoneal Radical Prostatectomy
Multi-Port Group:Multi-Port Extraperitoneal Radical Prostatectomy
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old and <= 85 years old, male; 2. Prostate adenocarcinoma was confirmed by systematic prostate biopsy. 3. The clinical stage was cT1c-cT2cN0M0 (according to the TNM staging system of AJCC 8th edition). 4, the patient was scheduled to undergo radical prostatectomy and was considered by the investigator to be suitable for robot-assisted extraperitoneal surgery. 5. The Eastern Cooperative Oncology Group performance status (ECOG) score was 0 or 1, and the patient could tolerate general anesthesia and radical surgery. 6. Voluntarily participated in this study, fully understood and signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous treatment related to prostate cancer, including but not limited to: local prostate ablation therapy, radiotherapy, etc. (except neoadjuvant endocrine therapy, which should be recorded and used as a stratification/analysis factor). 2. Previous history of transperitoneal prostate surgery, major pelvic surgery or radiotherapy is expected to seriously affect the anatomy of extraperitoneal space or increase the difficulty of surgery. 3, Imaging examination (such as MRI, bone scan, CT, etc.) suggested the presence of pelvic lymph node metastasis (N1) or distant metastasis (M1). 4. The presence of severe heart, lung, liver, kidney dysfunction or coagulopathy, which was evaluated by anesthesiology and urology, was contraindicated for robotic surgery and general anesthesia. 5, have any uncontrolled acute or chronic active infection. 6. Patients with a history of other malignant tumors and signs of activity in the past 5 years and stable tumor control could be enrolled. 7. Known or suspected history of psychiatric disorders, cognitive impairment, or alcohol/drug abuse, poor compliance, and inability to cooperate with the treatment and follow-up required by the study protocol. 8. Any other reasons for eligibility in the trial as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive surgical margin rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay;Duration of drain placement;PSA at 6 weeks postoperatively;Pain score at discharge;Intraoperative blood loss;90-day postoperative complication rate;1-year biochemical recurrence-free rate;Operative time;Urinary continence recovery;Sexual function recovery; | — |
Countries
China
Contacts
Public ContactJie Li
Lishui Central Hospital
Outcome results
None listed