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

Study Overview
=================
Brief Summary
-----------------
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 robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population. English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

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

Conditions
-----------------
Single-Port Colorectal Surgeries

Intervention / Treatment
-----------------
* Procedure: procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery. 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: Patients with missing data on the primary endpoint in retrospective cases; Subjects having any contraindications of single-port robot surgery; The intraoperative anatomy determined that minimally invasive surgery was not suitable; Patients who are considered inappropriate to participate in this study by investigator.
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098)<br> | Procedure: procedure<br>* procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative conversion rate |  | Intraoperative | 
| The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding volume |  | Intraoperative | 
| The rate of intraoperative blood transfusion |  | Intraoperative | 
| Surgical duration |  | Intraoperative | 
| Length of stay (LOS) |  | During the follow-up 1 day before discharge | 
| Admission to ICU and ICU LOS |  | During the follow-up 1 day before discharge | 
| Urethral catheter indwelling duration |  | in the follow-up 1 month after the surgery | 
| Postoperative pain score |  | follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery. | 
| Short-term recovery of functions |  | in the follow-up 1 month after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single-Port Colorectal Surgeries, low anterior resection of the rectum with or without total mesorectal excision, right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation, transanal minimally invasive surgery