A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)

Study Overview
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Brief Summary
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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.

Official Title
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A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries

Conditions
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Gynecological Surgeries

Intervention / Treatment
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* Device: da Vinci SP Surgical System


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RWS study for SP Gynecological Surgeries<br>da Vinci SP Surgical System(SP1098) | Device: da Vinci SP Surgical System<br>* Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: Intraoperative conversion rate |  | 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 |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding volume |  | Intraoperative | 
| Intraoperative blood transfusion rate |  | Intraoperative | 
| Surgical duration |  | Intraoperative | 
| Length of stay (LOS) |  | 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 |  | 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 |  | during the follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, high uterosacral ligament suspension