Department of Otorhinolaryngology, Aarhus University Hospital, Aarhus, Denmark.
Endocr Regul. 2024 Oct 1;58(1):181-186. doi: 10.2478/enr-2024-0021. Print 2024 Jan 1.
CoolSeal is a new vessel sealing system for dissection and hemostasis during surgery. No clinical studies have investigated safety, advantages or disadvantages regarding the use of this device. The aim of the present study was to investigate the safety of CoolSeal and compare it with conventional ligation technique or LigaSure during the total thyroidectomy. We hypothesized that the use of CoolSeal would reduce the operating time and bleeding without complications increase. Study design represents a retrospective cohort study with a tertiary reference center setting. We analyzed total thyroidectomy data from January 2021 to June 2023. We recorded patients' characteristics, surgical information, and postoperative outcome. We performed 221 total thyroidectomies in the study period. Analysis was restricted to 171 patients operated by only two surgeons. Hemostasis was secured by conventional ligation in 117 patients (68%), LigaSure in 34 patients (20%) and CoolSeal in 20 patients (12%). Median thyroid weight and bleeding were 67 g and 50 ml, respectively. Procedures using LigaSure or Cool-Seal were on larger glands (median 205 g) without increased bleeding (50 ml). Operating time was shortest with CoolSeal (96 min, p=0.003) compared with LigaSure (117 min) or conventional ligation (115 min). Bleeding was reduced with CoolSeal compared with LigaSure (45 vs. 100 ml, p=0.003). With CoolSeal, median hospitalization was one postoperative day, no patients required re-operation. There was no palsy of recurrent laryngeal nerves and no permanent hypoparathyroidism. In our first clinical experience, CoolSeal was safe and efficient for total thyroidectomy. With a small sample size, we saw a clinical benefit with reduced operating time without post-operative complications increase.
CoolSeal 是一种用于手术中解剖和止血的新型血管密封系统。目前还没有研究调查使用该设备的安全性、优势或劣势。本研究旨在调查 CoolSeal 的安全性，并将其与传统结扎技术或 LigaSure 在全甲状腺切除术的使用进行比较。我们假设使用 CoolSeal 可以减少手术时间和出血，而不会增加并发症。研究设计代表了一项回顾性队列研究，具有三级参考中心设置。我们分析了 2021 年 1 月至 2023 年 6 月期间的全甲状腺切除术数据。我们记录了患者的特征、手术信息和术后结果。在研究期间进行了 221 例全甲状腺切除术。分析仅限于仅由两位外科医生进行的 171 例患者。117 例（68%）患者采用常规结扎止血，34 例（20%）患者采用 LigaSure 止血，20 例（12%）患者采用 CoolSeal 止血。甲状腺重量和出血量中位数分别为 67 克和 50 毫升。使用 LigaSure 或 Cool-Seal 的手术是在更大的腺体上进行的（中位数 205 克），但出血量没有增加（50 毫升）。与 LigaSure（117 分钟）或常规结扎（115 分钟）相比，CoolSeal 的手术时间最短（96 分钟，p=0.003）。与 LigaSure 相比，CoolSeal 可减少出血（45 比 100 毫升，p=0.003）。使用 CoolSeal，中位住院时间为术后一天，无患者需要再次手术。没有喉返神经麻痹，也没有永久性甲状旁腺功能减退。在我们的首次临床经验中，CoolSeal 用于全甲状腺切除术是安全有效的。由于样本量较小，我们看到了手术时间缩短而无术后并发症增加的临床获益。
