Tsuchiya Akira, Komatsu Yasunori, Matsuyama Reiko, Tsuchiya Hiroko, Takemura Yuri, Nishii Osamu
Department of Obstetrics and Gynecology, University Hospital Mizonokuchi, Teikyo University School of Medicine, Kawasaki, Japan.
Gynecol Minim Invasive Ther. 2018 Jan-Mar;7(1):16-21. doi: 10.4103/GMIT.GMIT_6_17. Epub 2018 Feb 16.
To evaluate the TRUCLEAR™ system (Smith and Nephew Inc., London, UK), a hysteroscopic system that morcellates and aspirates masses, in terms of the operating time, surgeon's convenience, and effect on patients compared with conventional electrosurgical resection.
Patients undergoing hysteroscopic resection of endometrial polyps were randomly allocated to undergo hysteroscopic morcellation or electrosurgical resection (UMIN-CTR identifier: UMIN000019649). The primary outcome was the operating time. Secondary outcomes were the removal success, fluid deficit, convenience with the technique, insertion time, number of insertions during the operation, visibility of the operative field, recurrence of the patient's chief complaint, and adverse events.
Sixty-seven women were randomly allocated to the morcellation arm ( = 34) or electrosurgical resection arm ( = 33) from November 2015 to November 2016. The polyps were completely removed, and no adverse events were observed in all 67 patients. The average operating time (8.3 min vs. 12.0 min, = 0.014), insertion time (5.0 min vs. 9.0 min, < 0.001), and number of insertions (1.0 vs. 8.2, < 0.001) were significantly lower in the morcellation arm than in the electrosurgical resection arm. Surgeons' subjective evaluation measured on a 10-cm visual analog scale was higher in the morcellation arm than in the electrosurgical resection arm in terms of easiness of removal (8.4 vs. 6.5, < 0.001) and visibility of the operative field (7.8 vs. 6.4, < 0.001).
Surgeons gave the hysteroscopic morcellator system a better evaluation compared than electrosurgical resection, and the system shortened the operating time.
与传统电外科切除术相比，评估TRUCLEAR™系统（英国伦敦施乐辉公司），这是一种用于粉碎和抽吸肿物的宫腔镜系统，评估其手术时间、外科医生操作的便利性以及对患者的影响。
将接受宫腔镜下子宫内膜息肉切除术的患者随机分配接受宫腔镜粉碎术或电外科切除术（UMIN-CTR标识符：UMIN000019649）。主要结局指标为手术时间。次要结局指标包括切除成功率、液体缺失量、技术操作便利性、插入时间、手术期间插入次数、术野清晰度、患者主要诉求复发情况以及不良事件。
2015年11月至2016年11月，67名女性被随机分配至粉碎术组（n = 34）或电外科切除术组（n = 33）。所有67例患者的息肉均被完全切除，且未观察到不良事件。粉碎术组的平均手术时间（8.3分钟对12.0分钟，P = 0.014）、插入时间（5.0分钟对9.0分钟，P < 0.001）和插入次数（1.0次对8.2次，P < 0.001）均显著低于电外科切除术组。在10厘米视觉模拟量表上进行的外科医生主观评估显示，粉碎术组在切除的容易程度（8.4对6.5，P < 0.001）和术野清晰度（7.8对6.4，P < 0.001）方面高于电外科切除术组。
与电外科切除术相比，外科医生对宫腔镜粉碎器系统给予了更好的评价，且该系统缩短了手术时间。
