Bai Jigang, Zhang Miaomiao, Shi Aihua, Lin Yi, Guo Kun, Geng Zhimin, Zhang Dong, Ma Feng, Lyu Yi, Yan Xiaopeng
Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, 277 West Yanta Road, Xi'an, 710061, Shaanxi, China.
National Local Joint Engineering Research Center for Precision Surgery & Regenerative Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi, China.
Surg Endosc. 2023 Feb;37(2):1005-1012. doi: 10.1007/s00464-022-09562-7. Epub 2022 Sep 9.
There have been no prospective randomized controlled clinical trials evaluating the advantages of the magnetic anchor technique (MAT) used in reduced-port laparoscopic cholecystectomy (LC). The present study evaluated a novel magnetic anchor device designed by the authors.
Between April 2019 and June 2020, 60 patients with gallbladder diseases participated in a single-center, prospective, randomized controlled clinical trial. The patients were randomly apportioned to undergo either 2-port LC assisted by the novel MAT (MAT-2P-LC, experimental group) or conventional 3-port LC (3P-LC, control). The groups were compared regarding operative time, postoperative complications, surgical incision pain score (Wong-Baker), and other indicators. The patients were followed for 2 years.
The test and control groups were comparable in age, gender, body mass index, and primary disease. No patient in the MAT-2P-LC group was converted to 3P-LC. No patients were converted to laparotomy. On the first postoperative day, the Wong-Baker pain score of the experimental group (1.60 ± 0.67) was significantly lower than that of the control (2.20 ± 0.76; P = 0.002). The groups were statistically similar regarding intraoperative blood loss; operative time; time to leave bed; hospital stay; postoperative pain scores at 1 and 4 weeks; and complications.
This rigorous clinical trial shows that the novel MAT used to assist reduced-port LC significantly reduced postoperative pain, but has no obvious advantages in other terms. Clinical Trails.gov. number, ChiCTR1800019464.
尚无前瞻性随机对照临床试验评估磁锚定技术（MAT）在减少端口腹腔镜胆囊切除术（LC）中的优势。本研究评估了作者设计的一种新型磁锚定装置。
2019年4月至2020年6月期间，60例胆囊疾病患者参与了一项单中心、前瞻性、随机对照临床试验。患者被随机分配接受新型MAT辅助的两孔LC（MAT-2P-LC，实验组）或传统三孔LC（3P-LC，对照组）。比较两组的手术时间、术后并发症、手术切口疼痛评分（面部表情评分法）及其他指标。对患者进行了2年的随访。
试验组和对照组在年龄、性别、体重指数和原发性疾病方面具有可比性。MAT-2P-LC组无患者转为3P-LC。无患者转为开腹手术。术后第1天，实验组的面部表情疼痛评分（1.60±0.67）显著低于对照组（2.20±0.76；P=0.002）。两组在术中出血量、手术时间、下床时间、住院时间、术后1周和4周的疼痛评分以及并发症方面在统计学上相似。
这项严格的临床试验表明，用于辅助减少端口LC的新型MAT可显著减轻术后疼痛，但在其他方面无明显优势。Clinical Trails.gov编号，ChiCTR1800019464。
