Prospective randomised study using focus harmonic scalpel versus conventional hemostasis for vessel ligation in open thyroid surgery

Abstract

Background: The objective was to compare operative factors, postoperative and surgical complications of open thyroidectomy by using FOCUS harmonic scalpel (HS) versus conventional hemostasis.Methods: A prospective randomised study in which 34 patients with benign/malignant thyroid disease patients underwent open thyroidectomy, patients were randomised into two groups, Group -1(HS) - included 19 patients which FOCUS Harmonic scalpel was used exclusively, Group -2(CH) included 15 patients in which conventional hemostasis was used exclusively. We recorded operative time, postoperative blood loss and drain output, postoperative complications and duration of hospital stay, patients were watched for 48-72 hours following surgery. The results were analysed by using student’s t-test.Results: Mean operative time for hemithyroidectomy was 53.40±9.07 minutes in HS group versus 85.25±17.03 minutes in CH group (p-value -0.004) mean operative in patients who underwent near total thyroidectomy is 67.21±10.36 in HS group v/s 109.60±29.35ml in CH group (p-value 0.001), postoperative drain output in patients who underwent hemithyroidectomy in HS group is 16.00±15.16 v/s 36.25±4.78 ml in CH group (p-value 0.008), postoperative drain output in patients who underwent near total thyroidectomy in HS group is 28.21±16.36ml v/s 45.50±8.95ml in CH group(p-value 0.006),length of hospital stay is 3.28±1.06 days in HS group v/s 4.20±1.39days in CH group,(p-value-0.083), complications like temporary hypocalcemia was present in 1 patient in HS group v/s 3 patients in CH group ,temporary RLN palsy was present in 2 patients in each group, there were no cases of permanent RLN palsy in either group, neither were the cases of permanent hypoparathyroidism in either group.Conclusions: FOCUS Harmonic scalpel will reduce operative time, reduces the incidence of symptomatic hypocalcemia but not temporary hypocalcemia,reduces postoperative drain output, reduces the duration of hospital stay, and shows no significance on incidence of temporary/permanent RLN palsy. FOCUS harmonic scalpel supposed to be more reliable and safe instrument that can be used instead of conventional hemostasis techniques in open thyroidectomy.