At a glance
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Robotic Cholecystectomy Using the Newly Developed Chinese Robotic Surgical System-Micro Hand S: A Controlled, Randomized, Prospective Clinical Study
In Brief
A Early Phase 1 clinical trial evaluating robot-assisted cholecystectomy for Cholecystitis; Gallstone. Completed, enrolled 82 participants across 1 site.
Detailed Summary
A single-blinded, prospective randomized parallel controlled clinical trial was designed and conducted from December 2019 to November 2020. 82 patients with a gallstone, gallbladder polyp and other benign gallbladder diseases were enrolled in this study. Finally, 82 patients were randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Standard robot-assisted transabdominal cholecystectomy was conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative pain, comprehensive complication index, resident time and patient satisfaciton were recorded. The aim of the study is to determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in cholecystectomy compared with the prevalent da Vinci robot.
Study Details
Timeline
Interventions
cholecystectomy was performed for patients using the Chinese Micro Hand S surgical robot.
cholecystectomy was performed for patients using the da Vinci surgical robot.