This is the first in‐human trial and prospective case series of a novel single‐port robotic system for gynaecological surgery: An IDEAL stage 2a study

摘要

BACKGROUND: The Shurui® system (SR-ENS-600) is a novel fully integrated single-port robotic system with bioinspired serpentine surgical manipulators and a camera. METHODS: This was a single-centre prospective case-series study according to the IDEAL stage 2a guidelines to evaluate the feasibility, safety and potential efficacy of the Shurui® system for gynaecological surgeries and to improve the operating process. RESULTS: Ten patients with a gradient of surgical difficulty who had indications for laparoscopic surgery and who volunteered to participate in a clinical trial were enrolled in the study. All 10 subjects successfully completed the procedure without converting to other procedures. No serious complications were reported at the 3-month follow-up. Subjects recover faster after surgery and are highly satisfied with the incision. CONCLUSIONS: Gynaecological single-site laparoscopic surgery with the Shurui® system was technically feasible for well-selected patients with minimal alterations in technique. Further prospective multicenter large-sample studies are necessary. REGISTRATION NUMBER: ChiCTR2300075431. URL: https://www.chictr.org.cn/showproj.html?proj=189995.