Urological Surgery
Conditions
Interventions
Experimental group:Endoscopic surgical system (C1000) for urological surgery
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 80 years, and the gender is not limited; 2. Body mass index (BMI): 18~ 30 kg/m2; 3. Those who need to receive urological surgery; 4. The subject voluntarily participates in the clinical trial, and agrees or is agreed by the guardian to sign an informed consent form; 5. Those who are able to cooperate and complete the study follow-up and related examinations.
Exclusion criteria
Exclusion criteria: 1. Preoperative imaging shows distant metastasis; 2. Those with a history of urological surgery or a history of other malignancies who have been judged by the investigator to be unsuitable for enrollment; 3. Those who are expected to be unable to tolerate pneumoperitoneum or long-term Trendelenburg’s Position, or have diseases that cannot cooperate in the intraoperative position, such as spinal deformity, ankylosing spondylitis, etc.; 4. Those with severe comorbidities (heart, lung, liver, brain, kidney and other diseases) and weak constitution that cannot tolerate general anesthesia or surgery; 5. Those with severe bleeding tendency or coagulation dysfunction; 6. Patients who have been using anticoagulant and antiplatelet aggregation drugs for a long time, or those who have stopped anticoagulant and antiplatelet aggregation drugs for less than 1 week before surgery (except for preoperative prophylactic use of low molecular weight heparin); 7. Those who are in the active phase of infectious diseases or have other severe non-communicable infections; 8. Immunodeficiency virus (HIV) antibody positive, hepatitis B surface antigen (HbsAg) positive, hepatitis C virus (HCV) antibody positive, Treponema pallidum positive patients; 9. Those with severe allergies, suspected or determined to have alcohol, drugs or drug addiction; 10. Those with a history of epilepsy or psychiatric illness or cognitive impairment; 11. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial, or male or female patients who do not wish to use barrier contraception during the trial; 12. Participated in any other clinical trial (except non-interventional trials) within 3 months prior to signing the informed consent form, planned to undergo other major surgical treatment during the trial, or was unable to recover from the side effects of previous surgery; 13. Other circumstances that the investigator deems inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Installation time (min);Estimated blood loss (Intraoperarion);Surgeon's satisfaction;Length of hospital stay;Comprehensive Complication Index (CCI);Rate of postive surgical margin;Changes in prostate specific antigen concentration;Warm ischemic time;Changes in renal function;Remission of hydronephrosis; | — |
Countries
China
Contacts
Public ContactWang Linhui
Shanghai Changhai Hospital
Outcome results
None listed