明胶-凝血酶基质局部止血剂（弗洛塞尔）联合谐波手术刀在甲状腺全切除术中对患者有效：一项前瞻性、多中心、单盲、随机对照试验。

A Gelatin-Thrombin Matrix Topical Hemostatic Agent (Floseal) in Combination With Harmonic Scalpel Is Effective in Patients Undergoing Total Thyroidectomy: A Prospective, Multicenter, Single-Blind, Randomized Controlled Trial.

作者信息

Docimo Giovanni, Tolone Salvatore, Conzo Giovanni, Limongelli Paolo, Del Genio Gianmattia, Parmeggiani Domenico, De Palma Maurizio, Lupone Gennaro, Avenia Nicola, Lucchini Roberta, Monacelli Massimo, Gulotta Gaspare, Scerrino Gregorio, Pasquali Daniela, Bellastella Giuseppe, Esposito Katherine, De Bellis Annamaria, Pezzolla Angela, Ruggiero Roberto, Docimo Ludovico

机构信息

Second University of Naples, Naples, Italy

Second University of Naples, Naples, Italy.

出版信息

Surg Innov. 2016 Feb;23(1):23-9. doi: 10.1177/1553350615596638. Epub 2015 Aug 3.

DOI:10.1177/1553350615596638

PMID:26243629

Abstract

BACKGROUND

Hemostasis during thyroidectomy is essential; however, the safest, most efficient, and most cost-effective way to achieve this is unclear. This randomized, multicenter, single-blind, prospective study evaluated the efficacy and safety of using different hemostatic approaches in patients undergoing total thyroidectomy.

METHODS

Patients aged ≥18 to 70 years were randomized to Floseal + a harmonic scalpel (HS), Floseal alone, HS alone, or standard total thyroidectomy. Primary endpoint was 24-hour drain output. Secondary endpoints included surgery duration and complications.

RESULTS

Two hundred and six patients were randomized to Floseal + HS (n = 52), Floseal alone (n = 54), HS alone (n = 50), and standard total thyroidectomy (n = 50). The 24-hour drain output was lower in the Floseal + HS group compared with standard thyroidectomy. Floseal + HS also had a shorter surgery time (P < .0001) versus the other 3 treatments.

CONCLUSION

Floseal + HS can be effective at reducing postsurgical drain output and provides a complementary hemostatic approach in patients undergoing total thyroidectomy.

摘要

背景

甲状腺切除术中的止血至关重要；然而，实现这一目标的最安全、最有效且最具成本效益的方法尚不清楚。这项随机、多中心、单盲前瞻性研究评估了在接受全甲状腺切除术的患者中使用不同止血方法的疗效和安全性。

方法

年龄≥18至70岁的患者被随机分为纤维蛋白封闭剂+超声刀（HS）组、单纯纤维蛋白封闭剂组、单纯HS组或标准全甲状腺切除术组。主要终点是24小时引流量。次要终点包括手术时间和并发症。

结果

206例患者被随机分为纤维蛋白封闭剂+HS组（n = 52）、单纯纤维蛋白封闭剂组（n = 54）、单纯HS组（n = 50）和标准全甲状腺切除术组（n = 50）。与标准甲状腺切除术相比，纤维蛋白封闭剂+HS组的24小时引流量更低。与其他3种治疗方法相比，纤维蛋白封闭剂+HS的手术时间也更短（P < .0001）。