Phase I clinical case series of Micro Hand S surgical robot: a 5-year follow-up study

Background: The Micro Hand S surgical robot system is the first multi-cavity endoscopic surgical robot system in China approved for registration by the National Medical Products Administration (NMPA). From 2014 to 2019, a clinical phase I study involving 81 general surgery cases was conducted at a tertiary medical center to evaluate the long-term postoperative effects, safety, and clinical utility of this innovative system. Methods: A cohort of 81 patients from March 2014 to January 2019 was followed up regularly at 3 months, 6 months, 1 year, and every other year post-surgery. Follow-ups were conducted through in-hospital visits or telephone calls until the last patient was followed for 5 years or passed away. The primary follow-up measures included postoperative complications, second surgeries, disease recurrence, survival time, tumor metastasis, and quality of life assessments. Results: The procedures performed included radical sigmoidectomy (n=19), radical gastrectomy (n=16), radical right hemicolectomy (n=12), radical rectectomy (n=11), radical left hemicolectomy (n=5), cholecystectomy (n=4), gastric stromal tumor resection (n=3), and others (n=11). Analysis revealed no direct evidence linking the surgical robot system specifically to the patients' 5-year postoperative outcomes, despite its broad applicability. Conclusion: The Micro Hand S surgical robot system demonstrates safe, dependable, and reliable long-term postoperative outcomes. Its successful application in diverse general surgeries suggests it holds significant promise for expanding its use in clinical practice and improving patient care. Trial Registration： This study was registered on clinicaltrials.gov on June 15, 2015, and the registration ID is NCT02752698.