Initial Experience with Single Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single Port Robotic Platform

Abstract

BACKGROUND: Minimally invasive surgical techniques have been widely adopted in colorectal surgery. New technological breakthroughs have led to even less invasive alternatives like single-port surgery, but this has been hindered by technical challenges such as collision of the robotic arms within a limited space. The Intuitive da Vinci single port robotic platform is a novel system that overcomes some of these challenges. IMPACT OF INNOVATION: The aim of this study was to assess the safety and feasibility of the Intuitive da Vinci Single Port robotic platform in right segmental colectomies among adult patients. These findings may set the stage for more widespread use of single port robotic surgery. TECHNOLOGY MATERIALS AND METHODS: The Intuitive da Vinci Single-Port SP robot is a system designed specifically for single port robotic surgery. This platform enables flexible port location and efficient internal and external range of motion by utilizing a single C-shaped arm. In our study, right colectomies were performed in adult patients using this platform between May 2022 and November 2022 and compared to right colectomies in adult patients done using the standard multiport platform between Jan 2019- December 2022. The main outcome measure was safety and quality event rate. PRELIMINARY RESULTS: Among 5 patients who underwent single port robotic right colectomy, and 83.3% (n=25) underwent multiport right colectomy. In the single port group, 40% (n = 2) developed a safety/quality event (postoperative portal vein thrombosis and excessive postoperative pain). Of the multiport group, 32% (n = 8) had one safety/quality event, and 8% (n = 2) had more than one event. CONCLUSIONS AND FUTURE DIRECTIONS: This preliminary study, one of the first FDA-approved, investigator-initiated uses of this platform in colorectal surgeries, shows that this platform is a safe and feasible option for right colectomies and on preliminary evaluation appears comparable in terms of relevant safety/quality events to the multiport platform. Trial Registration: Clinicaltrials.gov NCT05321134 Trial Funding: American Society of Colon & Rectal Surgeons (ASCRS) Research Foundation.