Harmonic study: A cost-effectiveness evaluation of ultrasonically activated shears for total thyroidectomy [Lo studio HARMONIC: Valutazione costo-efficacia dell'uso del bisturi a ultrasuoni negli interventi di tiroidectomia totale]

Background: Total open thyroidectomy can be performed either with the conventional knot tying technique (nHS) or using the ultrasonically activated shears (harmonic scalpel, HS). The HS, developed in the '90s, initially used for laparoscopic surgery, is an innovative method for haemostasis that has been tested in thyroid surgery. Here, the use of the HS in conventional thyroid surgery compared with nHS is investigated in order to assess safety, cost-effectiveness, and the impact on the surgical outcome from an hospital and societal perspective. Methods: A randomized controlled trial was conducted at the University Hospital A. Gemelli in Rome from March 2007 till March 2008. Data refer to 198 patients eligible for total thyroidectomy (TT), randomized to either surgery with nHS (n=96) or HS (n=102) and followed for 3 months after hospital discharge. During hospitalization, operative time and resource consumption were recorded. Main clinical outcomes investigated were: pain (VAS score), quality of life (QoL, evaluated with EQ-5D), complications and cosmetic results. Direct medical and indirect costs were prospectively collected during the follow-up as well. Results: The analysis was performed on 198 patients, mean age 51 years old, 46 male (23%) and 152 female (77%), randomized to either nHS group (n=96) or HS (n=102). The two groups were well balanced in terms of age, sex, preoperative diagnosis, anesthesia type and QoL at enrolment. A significantly shorter operative time (nHS: 76.36 vs HS: 54.16 minutes, p<0.001) and total operating room (OR) occupancy time (100.59 vs 76.86 minutes, p<0.001) were observed, even if length of hospital stay was similar in both groups (median 5 days). From a clinical point of view complication rates and voice changes showed no significant differences. No significant improvement in QoL was perceived in HS group at discharge (0.83 vs 0.78, p = 0.063), whilst at 1 month (0.90 vs 0.83, p < 0.002), and at 3 months after surgery (0.91 vs 0.84, p = 0.002) differences were statistically significant. A lower postoperative pain was reported by HS patients 6 hours after surgery (VAS: nHS: 44, 56 vs HS: 41.35), but pain was similar after 48 hours (VAS: nHS: 20.97 vs HS: 22.75). 55% nHS patients were satisfied with scar's cosmetic result vs 71% HS patients (p = 0.029) 1 month after surgery. The economic evaluation considered direct medical costs and indirect costs. Total direct medical costs were ⠬2,540.52 and ⠬2,400.34 for nHS and HS, respectively. From the hos¬pital perspective, HS allows savings of ⠬119/patient, mainly due to lower charges for OR staff (nHS: ⠬452.90 vs HS: ⠬294.19), OR utilization (nHS: ⠬815.40 vs HS: ⠬620.61), drugs (nHS: ⠬93.28 vs HS: ⠬63.29), and diagnostic tests (nHS: ⠬160.36 vs HS: ⠬132.91). From a societal perspective, HS is also related to lower medical resource consumption during a 3 month follow-up after discharge (nHS: ⠬129.03 vs HS: ⠬107.82) and lower non-medical re¬source utilization (transport/hotels costs: nHS: ⠬535.51 vs HS: ⠬342.77). No statistical difference was found in productivity losses up to 3 months (nHS: ⠬377.71 vs HS: ⠬385.51). Conclusion: Harmonic is safe and effective in conventional TT, allowing a significant reduction of the operative time (-22min), total OR utilization time (-24 min), and improvement in QoL at 3 months (HS: 0.23 vs nHS: 0.21), without increasing complication rates and saving ⠬119 per patient from the hospital perspective. A positive impact on hospital resource consumption is also related to the surgical team skill in performing the TT. Harmonic should be adopted in TT to reduce impact on patient life and society, since it allows a overall saving of Euro 325.36 per patient.