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

Ruijin Hospital1 site in 1 country15 target enrollmentMarch 28, 2023

ConditionsSingle-Port Colorectal Surgeries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Single-Port Colorectal Surgeries
Sponsor: Ruijin Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Intraoperative conversion rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 28, 2023

End Date

August 15, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Zhao Ren

Pro.Zhao

Ruijin Hospital

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.

Outcomes

Primary Outcomes

Intraoperative conversion rate

Time Frame: Intraoperative

The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days

Time Frame: 30 days

Secondary Outcomes

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.)
Admission to ICU and ICU LOS(During the follow-up 1 day before discharge)
Surgical duration(Intraoperative)
Length of stay (LOS)(During the follow-up 1 day before discharge)
Intraoperative bleeding volume(Intraoperative)
The rate of intraoperative blood transfusion(Intraoperative)
Short-term recovery of functions(in the follow-up 1 month after the surgery)