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.

INTERLABORATORY CONCORDANCE IN HER-2 POSITIVE BREAST CANCER.

Accurate assessment of HER-2 status is essential for identifying patients who will benefit from HER-2 targeted therapy. The aim of the present study was to show results on the concordance between local and central laboratory testing results in HER-2 positive breast cancer patients. In cases with discordant findings, the immunohistochemical (IHC) and/or in situ hybridization (FISH/SISH) analysis was performed in central laboratories. A total of 104 out of 143 (72.72%) breast carcinoma cases were HER-2 positive (score 3+), while nearly 14% of tumors (20/43) showed weak (score 2+) and 12% (19/143) negative IHC staining (score 0 and 1+). After repeated IHC and ISH, 88% (126/143) were classified as HER-2 positive and 12% (17/143) as HER-2 negative cases. The results obtained are in agreement with many studies that confirmed similar discordance in HER-2 testing by IHC and/or FISH between local and central laboratory. Thus, our findings as well as those from other studies support the importance of regular quality assessment of the staining procedures performed and consistency of interpretation of HER-2 test results.