Diseases of the urinary system
Conditions
Interventions
The experimental group:Laparoscopic surgery using endoscopic surgical system developed by Agibot Medical Technology (Suzhou) Co., Ltd.
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing university Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-80 years old (inclusive), gender is not limited; 2.Body Mass Index (BMI): 18-30kg/m2 (inclusive); 3.Subjects who have been confirmed by the investigator to have relevant indications for urological surgery and are in a physiological condition that allows laparoscopic surgery; 4.Voluntarily participate in this clinical trial, and agree or have their guardian agree and sign the informed consent form for the subject; 5.Willing to cooperate and complete follow-up visits and related tests.
Exclusion criteria
Exclusion criteria: 1.Patients with abdominal infection, peritonitis, diaphragmatic hernia, and severe systemic infection; 2.Preoperative imaging examination indicates that there is distant metastasis; 3.Patients with diseases that are expected to be unable to tolerate a prolonged head-down foot-up position, diseases that are unable to tolerate pneumoperitoneum, or diseases that cannot cooperate with the intraoperative position, such as spinal deformities and ankylosing spondylitis; 4.Patients with severe bleeding tendency or coagulopathy, long-term use of anticoagulant and antiplatelet drugs, or patients who have stopped using anticoagulant and antiplatelet drugs for less than one week before surgery (except for preventive use of low molecular weight heparins before surgery); 5.Those who have serious cardiovascular or circulatory diseases and cannot tolerate surgery; 6.Patients with epilepsy or a history of mental illness or cognitive impairment; 7.Severe allergic constitution, suspected or confirmed drug addicts; 8.Pregnant or breastfeeding women, or women planning to become pregnant within 6 months; 9.Those who participated in other intervention clinical trials within 3 months before this trial or those who plan to undergo other major surgical procedures during the trial; 10.Investigators consider it inappropriate for the subject to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical non-conversion rate;The primary safety endpoint is the incidence of device-related or potentially device-related complications that meet or exceed the Clavien-Dindo grade 3 criteria from the time of the first incision to 30 days post-procedure.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Installation time;Intraoperative estimated blood loss;Operation time;Patient pain score;Transfusion rate;Postoperative hospital stay;Hot ischemia time;Positive margin rate;Renal function evaluation;Changes in prostate-specific antigen concentration.;The overall complication rate (Clavien-Dindo grade 1 or higher) from the first incision to 30 days post-procedure.;30-day re-admission rate, reoperation rate, and mortality rate.;Physician satisfaction evaluation; | — |
Countries
China
Contacts
Public ContactHongqian Guo
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing university Medical School
Outcome results
None listed