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.