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.
RCT Entities:
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.
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