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

AbstractBackgroundThe Shurui® system (SR‐ENS‐600) is a novel fully integrated single‐port robotic system with bioinspired serpentine surgical manipulators and a camera.MethodsThis 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.ResultsTen 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.ConclusionsGynaecological 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 numberChiCTR2300075431. URL: https://www.chictr.org.cn/showproj.html?proj=189995.