Safety of the harmonic scalpel versus conventional "clamp-and-tie" approach for intraoperative bleeding control
Soniya Shankar Kalpana1, G Tilak Ramu1, Balaji Durairaj2
1Department of General Surgery, SRM Medical College and Hospital & Research Centre, Faculty of Medicine and Health Sciences, SRM IST, Kattankulathur, Chengalpattu (Dt), Tamil Nadu, India.
Background:
Post-thyroidectomy complications including hypocalcemia, recurrent laryngeal nerve injury, and cervical hematoma remain important safety concerns. Although the harmonic scalpel improves operative efficiency, evidence regarding its impact on patient safety outcomes remains limited.
Methods:
In this prospective observational cohort study, 60 patients undergoing open thyroidectomy were allocated to harmonic scalpel (n = 30) or clamp and tie (n = 30) groups. The primary endpoints were safety outcomes, including hypocalcemia, recurrent laryngeal nerve injury, postoperative hematoma, surgical site infection, and composite complication rates. Secondary endpoints included operative time, intraoperative blood loss, drain output, postoperative pain, and length of hospital stay. Statistical significance was defined as p < 0.05.
Results:
Use of the harmonic scalpel was associated with a significant reduction in overall complications compared with the conventional technique (13.3% vs. 33.3%, p = 0.04). Transient hypocalcemia occurred less frequently in the harmonic scalpel group, accompanied by significantly higher postoperative calcium levels at 24 and 48 h. No recurrent laryngeal nerve injury or postoperative hematoma was observed in the harmonic scalpel group, although differences were not statistically significant. In addition to improved safety outcomes, harmonic scalpel use resulted in shorter operative duration, substantially reduced intraoperative blood loss, lower postoperative drain volumes, decreased pain scores, and reduced length of hospital stay.
Conclusion:
The harmonic scalpel was associated with improved operative efficiency and a lower overall complication burden without increasing major safety-related complications. Larger randomized multicenter studies are required to confirm these findings.
Clinical Trial Number:
Not applicable.
