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Randomized Controlled Trial of Harmonic Scalpel Use During Thyroidectomy
Paolo Miccoli, FACS;
Piero Berti, MD;
Gian L. Dionigi, MD;
Jacopo D’Agostino, MD;
Cinzia Orlandini, PhD;
Gianluca Donatini, MD
Arch Otolaryngol Head Neck Surg. 2006;132:1069-1073.
Objective To compare operative factors, postoperative outcomes, and surgical complications of thyroidectomy when using the harmonic scalpel (HS) vs conventional hemostasis (CH).
Design Single-blind, randomized controlled trial.
Setting Department of Surgery, S. Chiara Hospital, University of Pisa, Pisa, Italy.
Patients One hundred patients undergoing thyroidectomy.
Main Outcome Measures Postoperative pain, drainage volume, hypocalcemia, nerve injury, and operative time.
Intervention Patients underwent total thyroidectomy in which either the HS or CH was used.
Results We found no significant differences between the HS and CH groups at baseline. Postoperative pain was reduced in the HS group at 24 hours (mean visual analog scale score, 3.90 vs 5.30; P<.001) and 36 hours (2.27 vs 3.95; P<.001). Drainage volume was significantly lower in the HS group (40.1 mL vs 75.4 mL; P<.001). Transient hypocalcemia was significantly lower in the HS group (5 patients [10%] vs 16 [32%]; P = .01). No patients experienced nerve injury or permanent hypocalcemia. Mean operative times were shorter in the HS group (40.0 vs 46.7 minutes, P<.001).
Conclusions Use of the HS may reduce postoperative pain, drainage volume, and transient hypocalcemia in patients undergoing thyroidectomy. Shorter operative times and improved outcomes might justify the cost of the HS compared with that of CH.
Author Affiliations: Department of Surgery, University of Pisa, Pisa, Italy.
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