On July 19, 2022, AdventHealth Digestive Health Institute colorectal surgeon Mark Soliman, MD, completed the first complex colorectal surgical case in the Southeast U.S. using the da Vinci SP® Surgical System as part of a prospective, multi-center investigation titled da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures.
AdventHealth Altamonte is one of three sites in the world participating in this clinical trial, which aims to confirm the safety and performance of Intuitive’s single-port (SP) robotic surgical system in complex colorectal procedures such as low anterior resection and right colectomy. Dr. Soliman specializes in robotic colorectal surgery and serves as Principal Investigator for the study.
The da Vinci SP® Surgical System accommodates a three-dimensional articulating camera and three double-jointed articulating instruments. It is designed to allow a surgeon to reach anatomy in all four quadrants of the abdomen without redocking. The U.S. Food and Drug Administration (FDA) already approved the single-port system’s use for prostatectomy and certain ear, nose and throat (ENT) cases. The goal of this clinical trial is to secure FDA approval for complex colorectal procedures as well.
“The current robotic systems in use for colorectal surgery are multi-port, requiring at least 4 incisions,” explains Dr. Soliman. “This newer single-port system allows us to complete the same, intricate surgical work with just a single 2.5 cm incision, resulting in a faster, easier recovery for our patients with less pain.”
Primary outcome measures for the study include performance and adverse event rates. Performance is defined as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach such as open, multiport laparoscopic or multiport robotic. The safety endpoint assessment will include incidence of intraoperative and post-operative adverse events through a 42-day follow-up.
Dr. Soliman’s first case was successfully completed on a patient with an ascending colon cancer.
“She was home within 36 hours and has done excellent since,” reports Dr. Soliman.
“This patient knew she wanted a minimally invasive approach for her colorectal surgery and sought us out, traveling two to three hours away from her home to AdventHealth Altamonte for the procedure. We’re committed to advancing the field of robotic surgery and offering our patients access to the latest surgical innovations that will enhance their care and improve outcomes.”
The da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures aims to include 60 participants and is still actively enrolling. Click here to refer a patient for evaluation.
