Study name:A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological 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 robotic surgeries of gynecological benign and malignant tumors 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 English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Study Type
OBSERVATIONAL
Enrollment
15
Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPrimary efficacy endpoint: Intraoperative conversion rate
Time frame: Intraoperative
Primary safety endpoint: Incidence of device related or possibly related complications meeting the Clavien-Dindo Grading System level 3 or above criteria within 30 days after the surgery
Time frame: 30 days
Intraoperative bleeding volume
Time frame: Intraoperative
Intraoperative blood transfusion rate
Time frame: Intraoperative
Surgical duration
Time frame: Intraoperative
Length of stay (LOS)
Time frame: During the follow-up 1 day before discharge.The LOS is defined as the total inpatient days of each subject from the day of the surgery to the day of discharge (unit: days).
Admission to ICU and ICU LOS
Time frame: During the follow-up 1 day before discharge, the admission to ICU and ICU LOS (unit: days) of each subject should be recorded.
Postoperative pain score
Time frame: during the follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery
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