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

Abstract

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.

Keywords: enhanced recovery after surgery (ERAS); minimally invasive gynaecological surgery (MIGS); robotic‐assisted laparoscopic single‐site surgery (R‐LESS); single‐port robot system (SPRS).