Jakov Mihanović1,2, Nataša Lisica Šikić3, Ivana Mrklić4, Zvonimir Katušić1, Robert Karlo1,2, Miro Jukić5,6, Ana Jerončić7, Zenon Pogorelić8,9. 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 Biomedicine and Health, School of Medicine, University of Split, Split, Croatia. 8. Department of Surgery, School of Medicine, University of Split, Split, Croatia. zpogorelic@gmail.com. 9. Department of Pediatric Surgery, University Hospital of Split, Spinčićeva 1, 21000, Split, Croatia. zpogorelic@gmail.com.
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 underwentlaparoscopic 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.
RCT Entities:
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.