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.
Study Type
OBSERVATIONAL
Enrollment
15
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGIntraoperative conversion rate
Time frame: Intraoperative
incidence of device-related or likely related complications
Time frame: 30 days
Intraoperative bleeding volume
Time frame: Intraoperative
The rate of intraoperative blood transfusion
Time frame: Intraoperative
Surgical duration
Time frame: Intraoperative
Length of stay (LOS)
Time frame: up to 4 weeks
Admission to ICU and ICU LOS
Time frame: up to 4 weeks
Urethral catheter indwelling duration
Time frame: up to 4 weeks
Postoperative pain score
Time frame: 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
Time frame: in the follow-up 1 month after the surgery
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