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.
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Funding
This work was supported by the Innovation Capability Support Plan of Shaanxi Province of China (2020KJXX-022); the Key Research & Development Program-Social Development of Shaanxi Province of China (2021SF-163); Natural Science Basic Research Plan in Shaanxi Province of China (2020JZ-37) and the New Medical and New Technology Project of The First Affiliated Hospital of Xi’an Jiaotong University (XJYFY-2018W18).
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(I) Conception and design: JB, YL (Yi Lu), and XY; (II) Administrative support: YL (Yi Lyu), and XY; (III) Provision of study materials or patients: JB, KG, ZG, DZ, YL (Yi Lyu), and XY; (IV) Collection and assembly of data: MZ, AS, FM, and YL (Yi Lin); (V) Data analysis and interpretation: JB, MZ, AS, and XY; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
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During the conduct of this work, Jigang Bai, Miaomiao Zhang, Aihua Shi, Yi Lin, Kun Guo, Zhimin Geng, Dong Zhang, Feng Ma, Yi Lyu, and Xiaopeng Yan have no conflicts of interest to disclose.
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Bai, J., Zhang, M., Shi, A. et al. Magnetic anchor technique in laparoscopic cholecystectomy: a single-center, prospective, randomized controlled trial. Surg Endosc 37, 1005–1012 (2023). https://doi.org/10.1007/s00464-022-09562-7
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DOI: https://doi.org/10.1007/s00464-022-09562-7