UCSF Develops First of Its Kind Robotic Surgery Trial in Partnership with FDA

UCSF Health is recruiting patients for the only FDA-approved study of the use of single port robotic technology for colorectal surgery in the United States. UC San Francisco clinical investigators Ankit Sarin, MD, FACS, and Hueylan Chern, MD, initiated the study which will evaluate whether single port robot technology is more advantageous than the current multi-port technology used in colorectal surgery.

The purpose of this study is to understand how a robotic surgery device that uses a single access port (Intuitive Da Vinci Single Port SP system) differs from robotic surgery devices that use multiple access ports (Intuitive Da Vinci Multiport Xi System). The single port (SP) device being studied is currently approved by the FDA for use in urology and head and neck specialties, but UCSF worked with the FDA to obtain an investigational device exemption for its use in colorectal surgery.

Robotic surgery allows surgeons to perform complex surgical procedures in a minimally invasive manner, which is very challenging using conventional laparoscopy. Use of the robot during surgery improves visualization through 3D magnification and enhances dexterity for manipulation and dissection of tissue with greater precision. While the robotic instruments manipulate tissue, surgeons use the robotic surgical system to guide the robotic arms and movements of the surgical instruments.

Both types of robotic surgery offer important advantages over laparoscopy, including improved ergonomics and optics for the operating surgeon due to the unique wristed instruments. For rectal cancer specifically, the robot allows for a finer dissection of the rectum out of the tight space where it is located.

The single port system is designed to allow surgeons to perform surgery with one incision, instead of having multiple incisions made to the abdomen during surgery with the multiport system.

“Currently the FDA has recommended that we have 25 patients take part in this study and have surgery using the SP platform,” said Sarin, associate professor at UCSF’s Division of Surgical Oncology. “Their results will be compared to patients having the same surgeries using the multiport Xi platform.”

The FDA has approved this use for both transabdominal and transanal procedures. In both cases, instead of using multiple robotic arms to perform the procedure, a single arm with multiple channels will be used to perform the procedure. Patients are monitored very closely in the operating room and for months afterward to ensure there is a clear understanding of how the SP robotic platform differs from the multiport system.

The efficacy of the SP surgical system for colorectal surgery is evaluated by measuring factors such as vital signs, pain control, nausea, difficulty in performing the surgery, blood loss, recovery of bowel and bladder function, and the length of stay in the hospital.  The researchers are also evaluating 30-day outcomes including ileus, surgical site infections, deep vein thrombosis, pneumonia, sepsis, anastomotic leaks, readmissions and reoperations. Patients will be followed for 2 years for benign conditions and 5 years for malignant (cancer-related) conditions.

Funding: This study is funded by a grant from the American Society of Colon & Rectal surgeons. None of the investigators have financial or proprietary interests in the study.