Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendi
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ORIGINAL ARTICLE
Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis—a randomized clinical trial Jakov Mihanović 1,2 & Nataša Lisica Šikić 3 & Ivana Mrklić 4 & Zvonimir Katušić 1 & Robert Karlo 1,2 & Miro Jukić 5,6 & Ana Jerončić 7 & Zenon Pogorelić 5,6 Received: 19 October 2020 / Accepted: 17 November 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract 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 Keywords Lateral thermal damage . Single-use devices . Laparoscopic appendectomy . Reuse . Patient safety . Harmonic scalpel
* Zenon Pogorelić [email protected] 1
Department of Surgery, Zadar General Hospital, Zadar, Croatia
2
Department of Health Studies, University of Zadar, Zadar, Croatia
3
Department of Pathology, Forensic Medicine and Cytology, Zadar General Hospital, Zadar, Croatia
4
Department of Pathology, Forensic Medicine and Cytology, University Hospital of Split, Split, Croatia
5
Department of Surgery, School of Medicine, University of Split, Split, Croatia
6
Department of Pediatric Surgery, University Hospital of Split, Spinčićeva 1, 21000 Split, Croatia
7
Department of Research in Biomedic
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