Reviewed by Mila PereraSep 20 2022
UCSF Health is recruiting patients for the only FDA-approved research in the United States exploring using single port robotic technology for colorectal surgery. Ankit Sarin MD, FACS, and Hueylan Chern MD, of UC San Francisco, launched the study to determine whether single port robot technology is superior to the existing multi-port technology utilized in colorectal surgery.
Ankit Sarin, MD, FACS, one of the study’s clinical investigators. Image Credit: University of California
The research aims to comprehend how a robotic surgery device employing a single access port (Intuitive Da Vinci Single Port SP system) varies from robotic surgery devices that utilize multiple access ports (Intuitive Da Vinci Multiport Xi System).
The FDA approves the single port (SP) device currently being studied for use in head and neck specialties and urology. UCSF collaborated with the FDA to acquire an investigational device exemption for using it in colorectal surgery.
Robotic surgery enables physicians to conduct sophisticated surgical procedures less invasively, which would be impossible with traditional laparoscopy.
Using a surgical robot improves visibility through 3D magnification and increases dexterity for more precise manipulation and dissection of tissue. Surgeons employ the robotic surgical system to guide the robotic arms and movements of the surgical tools as the robotic instruments manipulate tissue.
Because of the unique wristed devices, both robotic surgery methods have significant advantages over laparoscopy, including superior ergonomics and optics for the operating surgeon. In the case of rectal cancer, the robot enables finer dissection of the rectum out of the restricted region where it is located.
The single port system is designed to help surgeons carry out surgery with a single incision rather than making many to the abdomen at the time of surgery with the multi-port system.
Currently the FDA has recommended that we have 25 patients take part in this study and have surgery using the SP platform. Their results will be compared to patients having the same surgeries using the multiport Xi platform.
Ankit Sarin, Associate Professor, Division of Surgical Oncology, University of California
The FDA approves the single port system for both transabdominal and transanal procedures.
Rather than employing multiple robotic arms to carry out the procedure, a single arm containing multiple channels is used in both cases. Patients are carefully monitored in the operating room and for several months after to ensure a comprehensive grasp of how the SP robotic platform differs from the multi-port system.
The SP surgical system’s efficiency in colorectal surgery is measured by parameters such as vital signs, pain control, nausea, difficulty in completing the surgery, blood loss, bowel and bladder function recovery, and length of hospital stay.
The scientists are also looking at 30-day outcomes such as surgical site infections, ileus, pneumonia, deep vein thrombosis, anastomotic leaks, sepsis, readmissions, and reoperations. Patients will be observed for two years if they have benign conditions and five years if they have malignant cancer-related conditions.
The American Society of Colon & Rectal surgeons provided a grant for the study.