prostate cancer
Conditions
Interventions
Control group:Routine single port laparoscopic radical prostatectomy
Test group 1:Single port laparoscopic radical prostatectomy with maximum urethral preservation requiring anastomosis
Test group 2:Single port laparoscopic radical prostatectomy with total urethral preservation without anastomosis
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Prostate cancer patients aged < 80 years diagnosed by pathology; 2. Clinical stage is below T3; 3. The score of physical fitness state of the eastern cancer cooperation group (ECoG) is <= 2 points; 4. Patients classified as grade I-III by the American Association of anesthesiologists (ASA) physical state classification system; 5. Be able to cooperate to complete the visits and relevant inspections specified in the plan; 6. The subjects voluntarily participated in the clinical trial and agreed or the guardian agreed to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prostate cancer patients with bone metastasis or visceral metastasis with clear imaging evidence (bone scan, MRI, pelvic CT plain scan + enhancement, PET-CT, etc.); 2. The pathological results of prostate were neuroendocrine carcinoma, including small cell carcinoma and prostate sarcoma; 3. Patients with prostate cancer whose urethra is highly suspicious or has been invaded were determined by preoperative evaluation; 4. Preoperative imaging examination showed prostate cancer patients with large prostate volume (>= 100mL) or prominent middle lobe (>= 2cm). History of severe urethral trauma and open surgery; 5. HIV antibody positive; Hepatitis B surface antigen (HBsAg) is positive and the copy number of hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection or the range of normal value; Hepatitis C virus (HCV) antibody positive; Patients with positive Treponema pallidum antibody and high risk of infection determined by the researcher; 6. Those who have serious systemic diseases and are judged by the researchers to be unsuitable for surgical treatment; 7. Long term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were stopped less than 1 week before operation), and patients with a history of hemorrhagic diseases or hematopoietic dysfunction or coagulation dysfunction; 8. Severe allergic constitution and suspected or confirmed alcohol, drug or drug addicts; 9. Patients with epilepsy or mental history or cognitive impairment; 10. Within 3 months before enrollment and planned to undergo other large-scale surgery during the trial, or unable to recover from the side effects of any such surgery; 11. Those who participated in other interventional clinical trials within 3 months before screening; 12. Previous history of pelvic radiotherapy or surgery; 13. Patients with active tuberculosis; 14. Have tumors of other systems or organs; 15. Other conditions that the researcher believes are not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary control;Surgical safety;Histopathology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction;Drainage tube and catheter removal time; | — |
Countries
China
Contacts
Public ContactZhu Qingyi
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed