Performance and operative outcomes' evaluation of a hand-held articulating laparoscopic device: a prospective clinical trial on the HandX™ platform.

Abstract

The advent of laparoscopic surgery has revolutionized general surgery, yet ergonomic limitations of conventional instruments persist. Robotic platforms have addressed some of these issues but are hindered by high costs and complexity. Hand-held articulating laparoscopic instruments offer a potential intermediary solution. This study assesses the HandX device performance and post-operative outcomes. This prospective, single-arm trial enrolled 60 patients intended for elective minimally invasive abdominal surgery from March 2018 to January 2022 at Assuta Medical Center and Shamir Medical Center. The study evaluated the hand-held device performance, deficiencies, conversion rate, and post-operative complications within a minimum of 14 days. Sixty patients underwent MIS using the evaluated device without conversion to conventional instruments. The predominant indication for surgery was abdominal wall hernia (48.3%), followed by cholecystectomy (15%). The mean System Usability Scale for evaluating device performance was 84.9, indicating high usability. One device deficiency was noted. No intraoperative complications or device-related post-operative morbidity were observed. Postoperative complications included one superficial surgical site infection and non-device-related medical events. The HandX device exhibits a favorable user experience with no device-related morbidity. Hand-held articulating devices offer a valuable intermediary between conventional laparoscopic instruments and robotic platforms.