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）

Completed

• Conditions: Single-Port Colorectal Surgeries
• Interventions: Procedure: procedure

• Registration Number: NCT06141421
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. 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.
2. 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

1. Patients with missing data on the primary endpoint in retrospective cases;
2. Subjects having any contraindications of single-port robot surgery;
3. The intraoperative anatomy determined that minimally invasive surgery was not suitable;
4. Patients who are considered inappropriate to participate in this study by investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098)	procedure	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Urethral catheter indwelling duration	in the follow-up 1 month after the surgery
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

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China