UCSF partners with FDA for robotic surgery trial

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Intuitive’s Da Vinci SP and Da Vinci Xi surgical systems. | Source: Intuitive

UCSF Health, part of UC San Francisco, is preparing for the only FDA-approved study of the use of single port robotic technology for colorectal surgery in the U.S. The hospital will be evaluating how Intuitive’s Da Vinci Single Port SP system, a robotic surgery device using a single access port, differs from Intuitive’s Da Vinci Multiport Xi System, a device that uses multiple access ports.

The Da Vinci Single Port SP system has already been approved by the FDA for urology and head and neck specialties, so UCSF worked with the FDA to get an investigational device exemption for its use in colorectal surgeries. The device was approved for both transabdominal and transanal procedures.

Ankit Sarin, MD, FACS, and Hueylan Chern, MD, two clinical investigators at UCSF, initiated the study.

Single port systems are designed to let surgeons perform surgeries with just one incision, instead of the multiple incisions required for a multiport system or a traditional laparoscopy. During robotic-assisted surgeries, surgeons guide the movements of robotic arms using the robotic surgical system. Those arms guide the movements of surgical instruments that manipulate tissue.

Robotic surgical systems can improve visualization for surgeries with its 3D magnification. The system also has enhanced dexterity and can operate with greater precision than human hands.

During the study, a single arm with multiple channels will perform transabdominal and transanal procedures. Patients will be closely monitored in the operating room and for months afterward to ensure the researchers have an understanding of how the single port robotic system differs from the multiport system.

The researchers will measure how effective the single port system is by measuring factors like vital signs, pain control, nausea, difficulty in performing the surgery, blood loss, recovery of bowel and bladder function and length of hospital stay. The team will also evaluate 30-day outcomes including ileus, surgical site infections, deep vein thrombosis, pneumonia, sepsis, anastomotic leaks, readmissions and operations.