Park Shin-Young, Shin Myung Ho, Hwang Young Mi, Choi Yun Suk, Yi Jin Wook
Department of Surgery, Inha University Hospital & College of Medicine, Incheon, Korea.
Gland Surg. 2023 Sep 25;12(9):1191-1202. doi: 10.21037/gs-23-227. Epub 2023 Sep 18.
The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is the most recently developed minimally invasive technique with no skin incision. For tissue dissection and bleeding control, the use of proper energy devices is very important in endoscopic thyroid surgery. To date, there have been no clinical studies reported regarding which energy device is better in TOETVA, ultrasonic shears or advanced bipolar device. The aim of our study is to determine which energy device is more useful for TOETVA.
This study was designed as an open-label, prospective randomized controlled trial in a single university hospital. Patients were randomly assigned to the ultrasonic group or advanced bipolar group before the surgery. From June 2020 to May 2022, 40 patients were enrolled (20 patients were assigned to the ultrasonic group, and 20 patients were assigned to the advanced bipolar group). Primary endpoints were operation time for lobectomy, number of camera cleanings, and blood loss during the lobectomy. Secondary endpoints were pain score, postoperative drainage, and blood chemistry. A single endocrine surgeon had performed all surgeries.
There were no significant differences between the two groups in age, sex, body mass index (BMI), tumor location, preoperative cytology, or surgical extent. The time for lobectomy was significantly shorter in the advanced bipolar group (33.8±6.4 41.9±9.0 minutes, P=0.002). The number of camera cleanings was significantly lower in the advanced bipolar group (2.9±1.6 5.8±2.5 times, P<0.001). Estimated blood loss was also significantly less in the advanced bipolar group (11.5±17.3 81.8±99.5 mL, P=0.004). Postoperative hospital stays, drainage, pain score, laboratory findings, and complications were not significantly different between the two groups.
According to this study, advanced bipolar device showed better performance, with a shorter operation time, less camera cleaning, and less blood loss. We suggest that advanced bipolar device can be a better choice in TOETVA.
ClinicalTrials.gov identifier: NCT04320901.
经口内镜甲状腺手术前庭入路(TOETVA)是最近开发的无皮肤切口的微创技术。在内镜甲状腺手术中,使用合适的能量设备对于组织解剖和出血控制非常重要。迄今为止,尚无关于在TOETVA中哪种能量设备(超声刀或先进双极设备)更好的临床研究报道。我们研究的目的是确定哪种能量设备对TOETVA更有用。
本研究设计为在一家大学医院进行的开放标签、前瞻性随机对照试验。患者在手术前被随机分配到超声组或先进双极组。2020年6月至2022年5月,共纳入40例患者(20例患者被分配到超声组,20例患者被分配到先进双极组)。主要终点是叶切除术的手术时间、摄像头清洁次数和叶切除术中的失血量。次要终点是疼痛评分、术后引流和血液生化指标。所有手术均由一名内分泌外科医生完成。
两组在年龄、性别、体重指数(BMI)、肿瘤位置、术前细胞学检查或手术范围方面无显著差异。先进双极组的叶切除时间明显更短(33.8±6.4对41.9±9.0分钟,P = 0.002)。先进双极组的摄像头清洁次数明显更少(2.9±1.6对5.8±2.5次,P < 0.001)。先进双极组的估计失血量也明显更少(11.5±17.3对81.8±99.5 mL,P = 0.004)。两组之间的术后住院时间、引流、疼痛评分、实验室检查结果和并发症无显著差异。
根据本研究,先进双极设备表现出更好的性能,手术时间更短,摄像头清洁次数更少,失血量更少。我们建议先进双极设备在TOETVA中可以是更好的选择。
ClinicalTrials.gov标识符:NCT04320901。