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）

NCT06141421 | Completed FDA Device

• 1 other identifier: ISFMT-SP-003
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Single-Port Colorectal Surgeries

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (1)

RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098)

Procedure: procedure

Interventions

procedure PROCEDURE

procedure

RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro.Zhao

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: March 28, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)