Status:
COMPLETED
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）
Lead Sponsor:
Ruijin Hospital
Conditions:
Single-Port Colorectal Surgeries
Eligibility:
All Genders
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 wor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06141421
Start Date
March 28 2023
End Date
August 15 2024
Last Update
December 12 2024
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025