Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis-a randomized clinical trial
Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis-a randomized clinical trial
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DOI：
10.1007/s00423-020-02039-y
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发表时间：
2020-11-25
影响因子：
2.3
通讯作者：
Pogorelic, Zenon
中科院分区：
文献类型：
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作者：
Mihanovic, Jakov;Sikic, Natasa Lisica;Pogorelic, Zenon
本研究的目的是比较腹腔镜阑尾切除术后使用新型和重复使用的谐波刀对阑尾外侧热损伤的影响和临床结果。方法对连续100例急性阑尾炎行腹腔镜阑尾切除术的患者进行双中心随机临床试验。使用计算机随机数生成器，将患者分配到新组或重用组。各组间比较阑尾基底和阑尾系膜外侧热损伤的组织病理学测量、阑尾基底横断速度、手术时间、装置功能主观评分、住院时间和并发症。结果新组（N = 49）阑尾基部中位外侧热损伤为0.2 mm (IQR 0.1 ~ 0.2)，重复使用组（N = 51）为0.1 mm (IQR 0.1 ~ 0.3) (P = 0.644)，两组阑尾系膜热损伤为0.1 mm (IQR 0.1 ~ 0.2) （P = 0.418）。两组中位碱基横切所需时间为8 s (IQR 7-9) （P = 0.776）。两组间的中位手术时间也具有可比性（22 min, IQR 20-30 vs 25 min, IQR 21-35; P = 0.233）。新组术后并发症2例，重复使用组术后并发症1例（4% vs 2%; P = 0.536）。外科医生对器械的主观评价在所有调查类别中没有显示出组间的显著差异。结论我们的研究结果支持谐波手术刀的重复使用，特别是在经济限制可能阻碍大量患者获得微创手术的情况下。腹腔镜阑尾切除术的结果可能无法在其他要求更高的手术中重现。
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.