Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis-a randomized clinical trial.
BACKGROUND
The aim of this study was to compare lateral thermal damage of the appendix and clinical outcomes after laparoscopic appendectomy using new versus reused Harmonic scalpels.


METHODS
A total of 100 consecutive patients with acute appendicitis who underwent laparoscopic appendectomy were enrolled in the two-center, randomized clinical trial. Using a computer random number generator, patients were allocated to new or reused group. Histopathological measurement of lateral thermal damage of the appendiceal base and mesoappendix, speed of transection of the appendiceal base, duration of surgery, subjective rating of device functionality, length of hospital stay, and complications were compared within groups.


RESULTS
The median lateral thermal damage on the appendiceal base in the new group (N = 49) was 0.2 mm (IQR 0.1-0.2) and 0.1 mm (IQR 0.1-0.3) in the reused group (N = 51) (P = 0.644), while on the mesoappendix for both groups, thermal damage was 0.1 mm (IQR 0.1-0.2) (P = 0.418). The median time required for base transection in both groups was 8 s (IQR 7-9) (P = 0.776). The median duration of surgery was also comparable between the groups (22 min, IQR 20-30 vs 25 min, IQR 21-35; P = 0.233). Two postoperative complications in the new group and one in the reused group were recorded (4% vs 2%; P = 0.536). Surgeons' subjective assessment of the instrument did not reveal significant difference between the groups in all of the investigated categories.


CONCLUSIONS
The results of our study support the reuse of Harmonic scalpels especially in the settings where economic constraints might hamper access to minimally invasive surgery to a larger number of patients. The results obtained on laparoscopic appendectomy might not be reproducible to other more demanding surgical procedures.


TRIAL REGISTRATION
ClinicalTrials.gov registry under identifier NCT04226482.
['Mihanović|Jakov|J|', 'Šikić|Nataša Lisica|NL|', 'Mrklić|Ivana|I|', 'Katušić|Zvonimir|Z|', 'Karlo|Robert|R|', 'Jukić|Miro|M|', 'Jerončić|Ana|A|', 'Pogorelić|Zenon|Z|http://orcid.org/0000-0002-1517-720X']
D000208:Acute Disease D001062:Appendectomy D001064:Appendicitis D001065:Appendix D006801:Humans D010535:Laparoscopy D007902:Length of Stay D011183:Postoperative Complications
Reuse Harmonic scalpel Laparoscopic appendectomy Lateral thermal damage Patient safety Single-use devices