Urological Surgeries
Conditions
Keywords
SP single-port robot, radical prostatectomy, partial nephrectomy, radical nephrectomy, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries
Brief summary
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries； Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System (SP single-port robot for short) for single-port urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population. Study design：Retrospective + prospective, real-world study Investigational medical device： English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Interventions
DEVICESP
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Inclusion criteria
Subjects should meet all the following criteria: 1. Subjects who have received or plan to receive RP, PN, RN, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic surgeries with the SP single-port robot; 2. Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Exclusion criteria
The subjects meeting any of the following criteria should be excluded. 1. Patients with missing data on the primary endpoint in retrospective cases; 2. Subjects having any contraindications of single-port robot surgery; 3. The intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. Patients who are considered inappropriate to participate in this Study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative conversion rate | Intraoperative |
| incidence of device-related or likely related complications | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Surgical duration | Intraoperative |
| Length of stay (LOS) | up to 4 weeks |
| Admission to ICU and ICU LOS | up to 4 weeks |
| Intraoperative bleeding volume | Intraoperative |
| Postoperative pain score | follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery. |
| Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function | in the follow-up 1 month after the surgery |
| Urethral catheter indwelling duration | up to 4 weeks |
| The rate of intraoperative blood transfusion | Intraoperative |
Countries
China
Outcome results
None listed