Jigang Bai1,2, Miaomiao Zhang1,2, Aihua Shi2, Yi Lin1, Kun Guo1, Zhimin Geng1, Dong Zhang1, Feng Ma2, Yi Lyu3,4, Xiaopeng Yan5,6. 1. Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, 277 West Yanta Road, Xi'an, 710061, Shaanxi, China. 2. 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. 3. Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, 277 West Yanta Road, Xi'an, 710061, Shaanxi, China. luyi169@xjtu.edu.cn. 4. 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. luyi169@xjtu.edu.cn. 5. Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, 277 West Yanta Road, Xi'an, 710061, Shaanxi, China. yanxiaopeng99@163.com. 6. 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. yanxiaopeng99@163.com.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.