CompletedNot Applicable

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）

China15 participantsStarted 2023-03-28

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Intraoperative conversion rate

Timeframe: Intraoperative

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

Timeframe: 30 days

Trial details

NCT IDNCT06141421

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Single-Port Colorectal Surgeries trials