Preclinical evaluation of the new EDGE SP 1000 single-port robotic surgical system in gynecology minimal access surgery.

Abstract

The aim of this study is to evaluate the feasibility and safety of a new single-port robotic surgical system for gynecological surgery in the porcine model. Six female Tibetan miniature pigs underwent robot-assisted single-port laparoscopic total hysterectomy with the newly developed single-port EDGE SP1000 platform. Estimated blood loss (EBL), docking time, operative time, and intraoperative and postoperative complications were recorded. Postoperative pain was assessed by VAS (visual analog scale) score at 6h, 12h, 24h, and 48h. Then the experimental animals were observed for one week after surgery to assess their mental status, incisional infections and finally euthanized for necropsy to assess the recovery of the vaginal stump. Six hysterectomies of pigs were successfully completed. There were no significant intraoperative complications in the six surgeries. The average total operation time was 113.33min (95-143min), and the average docking time was 5.5min (4-7min). The average EBL was 10ml (5 ~ 20ml). The mean VAS scores at 6, 12, 24, and 48h postoperatively were 6.3, 5.7, 5, 3, respectively. At 7days postoperatively, no significant incisional infections or other complications were observed. Post-euthanasia examination of the pelvis showed no significant abnormalities in the vaginal stump. This preclinical study of a new single-port surgical system for gynecologic procedures demonstrated the safety and feasibility of the EDGE SP1000 system in porcine models. Further studies are required to assess its clinical utility in the future.