Department of General Surgery, Third Xiangya Hospital, Central South University, 138 Tongzipo Lu, Yuelu Qu, Changsha, 410000, Hunan, China.
World J Surg. 2022 Nov;46(11):2632-2641. doi: 10.1007/s00268-022-06668-w. Epub 2022 Jul 20.
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).
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.
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).
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.
This study was registered at ClinicalTrials.gov (NCT04122261). URL: https://clinicaltrials.gov/ct2/show/NCT04122261.
通过比较微手机器人辅助胆囊切除术（MRC）和达芬奇机器人辅助胆囊切除术（DRC）治疗良性胆囊疾病患者的临床结果，评估 MRC 的临床疗效。
这是一项前瞻性、多中心、单盲、随机对照临床试验。本研究将 166 例良性胆囊疾病患者随机分为两组，分别接受 MRC 或 DRC 治疗（MRC 组 83 例；DRC 组 83 例）。主要终点为手术成功率。次要终点为对接时间、控制台时间、总手术时间、术中出血量、胆囊破裂率、术后疼痛、首次排气时间、综合并发症指数（CCI）和住院时间。随访时间为 30 天。
无中转开腹。与 MRC 相比，DRC 组的对接时间更长（12.04 分钟比 16.39 分钟，P=0.025），胆囊破裂率更高（4.8%比 15.7%，P=0.021）。与 DRC 相比，MRC 组术后疼痛评分更高（4.0 分比 3.0 分，P=0.038）。两组控制台时间、术中出血量和胆囊破裂率相当（P＞0.05）。两组术后结果和并发症无差异（P＞0.05）。
在良性胆囊疾病患者中，MRC 与达芬奇手术机器人相比无明显临床劣势。MRC 有效且安全，为手术治疗提供了更多选择。
本研究在 ClinicalTrials.gov 注册（NCT04122261）。网址：https://clinicaltrials.gov/ct2/show/NCT04122261。
