Led by Ankit Sarin, MD, and Hueylan Chern, MD, the study will examine whether single port robot technology is more advantageous than the current multiport technology used in colorectal surgery.
The single port device, Intuitive’s Da Vinci Single Port SP system, being studied is FDA-approved 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. The SP system will be compared with the Intuitive Da Vinci Multiport Xi System, a multiport robotic technology.
Both types of robotic surgery offer advantages over laparoscopy, including improved ergonomics and optics for surgeons due to the unique wristed instruments, UCSF said in a Sept. 19 news release. 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,” Dr. Sarin, associate professor at UCSF’s surgical oncology division, said in the release. “Their results will be compared to patients having the same surgeries using the multiport Xi platform.”
The efficacy of the SP system will be 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. Researchers will also examine 30-day outcomes including ileus, surgical site infections, deep vein thrombosis, pneumonia, sepsis, anastomotic leaks, readmissions and reoperations.
Patients will be followed for two years for benign conditions and five years for malignant conditions, according to UCSF.
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