Micro-Hand Robot-Assisted Versus da Vinci Robot-Assisted Cholecystectomy: A Multi-centre, Randomized Controlled Trial.

OBJECTIVE: To evaluate the clinical effectiveness of micro-hand robot-assisted cholecystectomy (MRC) by comparing the clinical outcomes of patients with benign gallbladder disease treated with micro-hand or da Vinci robot-assisted cholecystectomy (DRC). METHODS: This is a prospective, multi-centre, single-blind, and randomized controlled trial. In this study, 166 patients of benign gallbladder disease were randomized enrolled into two groups and received MRC or DRC (83 in the MRC group; 83 in the DRC group). The primary endpoint was surgical success rate. Secondary endpoints were the docking time, console time, total operation time, intraoperative blood loss, gallbladder breakage rate, postoperative pain, time of first flatus, the comprehensive complication index (CCI), and the hospital stay of the subjects. The duration of follow-up was 30 days. RESULTS: No conversion occurred. Compared with MRC, the DRC group showed longer docking time (12.04 min vs. 16.39 min, P = 0.025) and higher gallbladder breach rate (4.8% vs. 15.7%, P = 0.021). The MRC group showed higher postoperative pain scores compared to DRC (4.0 vs 3.0, P = 0.038). The console time, intraoperative blood loss, and gallbladder breach rate were comparable in these two groups (P > 0.05). No differences were observed in postoperative outcomes and complications between the two groups (P > 0.05). CONCLUSIONS: In patients with benign gallbladder disease, the MRC showed no obvious clinical disadvantage compared with the da Vinci surgical robot. MRC is effective and safe and provides more options for surgical treatment. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (NCT04122261). URL: https://clinicaltrials.gov/ct2/show/NCT04122261.