Overview
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.
Eligibility
Inclusion Criteria:
- Female patients who have received or plan to receive gynecological surgeries with the SP single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension.
- Patients who voluntarily participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Exclusion Criteria:
- Patients with missing data on the primary endpoint in retrospective cases;
- Patients having any contraindications of single-port robot surgery;
- The intraoperative anatomy demonstrate that minimally invasive surgery is not suitable;
- Patients who are considered inappropriate to participate in this Study by investigators.