Safety and Effectiveness of SAF-R, a Novel Patient Positioning Device for Robot-Assisted Pelvic Surgery in Trendelenburg Position

Abstract

We found current robotic positioning devices to be inadequate and cumbersome. Furthermore, we realized there were no premarket well-designed studies to prove their safety and efficacy. In this prospective pilot study, we aimed to investigate the safety and effectiveness of a novel patient-positioning device (SAF-R) to secure the patient in Trendelenburg (T-burg) position for robot-assisted pelvic surgery. Sixteen patients undergoing robot-assisted pelvic operation in T-burg position were enrolled. Patients were positioned using SAF-R board. Pressure sensor mats were used for real-time monitoring of the contact pressures and contact area on the shoulders and calves throughout the surgery. Data collection included patients' body mass index (BMI), time needed for positioning, total time in the T-burg position, contact pressure and contact area readings from the sensor mats, and the patient shifting distance on the table. Patients were also followed for 1-month postoperatively for any position-related adverse event. The median age of the patients was 56.5 years with median BMI of 27.3. The median positioning time was 6 minutes, duration of T-burg position was 3.5 hours, and patient shift on the table was 1 cm. The contact pressure over the shoulders was in the safe range (< 80 mm Hg) before and at the end of the surgery in all cases (right: 13.12 ± 1.12 vs 20.25 ± 1.56 mm Hg, left: 12.84 ± 1.05 vs 19.60 ± 1.09 mm Hg, p = 0.001). The changes in the mean contact pressure over the calves and the mean contact area for the shoulders and calves during the T-burg position were not significantly different. No significant position-related complication was detected during follow-up. SAF-R surgical board is a safe, reliable, and timesaving positioning device for patients undergoing robotic pelvic surgery in the T-burg position.