The only FDA-approved study of single port robotic surgical technology for colorectal surgery in the United States is being prepared by UCSF Health, a division of UC San Francisco. The hospital will compare the Da Vinci Single Port SP system from Intuitive, a robotic surgery device using a single access port, to the Da Vinci Multiport Xi System from Intuitive, a device using multiple access ports.
The FDA has already given the Da Vinci Single Port SP system approval for use in urology and head and neck procedures, so UCSF collaborated with the FDA to obtain an investigational device exemption for its use in colorectal operations. Both transabdominal and transanal procedures can use the device.
The study was started by Hueylan Chern, MD, and Ankit Sarin, MD, FACS, two clinical investigators at UCSF.
Instead of the numerous incisions needed for a multiport system or a conventional laparoscopy, single port systems are made to allow surgeons to perform surgeries through just one incision. Surgeons use the robotic surgical system to direct the robotic arms’ movements during robotic-assisted surgeries. The surgical instruments that manipulate tissue are moved by those arms.
Robotic surgical systems’ 3D magnification can enhance surgical visualization. In addition, the system has improved dexterity and is more precise than human hands.
Transabdominal and transanal procedures will be carried out during the course of the study using a single arm with multiple channels. To help researchers understand how the single port robotic system differs from the multiport system, patients will be closely monitored both during surgery and for several months afterward.
By monitoring variables like vital signs, pain management, nausea, difficulty performing the surgery, blood loss, restoration of bowel and bladder function, and length of hospital stay, the researchers will assess the effectiveness of the single port system. Along with 30-day results, the team will look at operations, readmissions, ileus, surgical site infections, deep vein thrombosis, pneumonia, sepsis, anastomotic leaks, and operations.
