甲状腺手术后应用脱细胞真皮基质的安全性和抗粘附效果:一项多中心随机对照试验。

IF 1.2 4区 医学 Q3 SURGERY
Kwangsoon Kim, Young Jun Chai, Mira Han, Sang-Wook Kang, Ji-Sup Yun
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引用次数: 0

摘要

目的:甲状腺手术后粘连可导致多种并发症,严重影响生活质量。脱细胞真皮基质(ADM)粘连屏障装置的使用被认为是减少这种粘连风险的潜在解决方案。本研究旨在评价一种ADM在甲状腺手术患者中的安全性和抗粘连效果。方法:在这项多中心随机对照试验中,接受甲状腺手术的患者被随机分配到手术期间接受ADM (n = 42)和不接受ADM (n = 39)。主要终点是术后6周的吞咽障碍评分(SIS-6),并在两组之间进行比较。次要结果包括组间比较SIS-6、语音障碍指数(VHI)-10和格拉斯哥-爱丁堡喉咙量表(GETS)在基线、术后2周、6周和18周。结果:在第6周,ADM组和对照组的SIS-6平均评分分别为4.0±4.1和3.3±4.2,差异无统计学意义。两组术后SIS-6、VHI-10和GETS评分随时间的改善情况相似,各组之间在任何时间点均无显著差异,表明与对照组相比,ADM没有减少术后粘连的发生率或改变恢复过程。结论:虽然在甲状腺手术患者中应用ADM是安全的,但在预防术后粘连方面没有明显的临床优势。未来的研究应侧重于确定使用ADM可能有益的特定患者群体或手术场景。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The safety and anti-adhesive effect of acellular dermal matrix application after thyroid surgery: a multicenter randomized controlled trial.

Purpose: Postoperative adhesions following thyroid surgery can lead to multiple complications that significantly impact quality of life. The use of an acellular dermal matrix (ADM) adhesion barrier device has been proposed as a potential solution to reduce the risk of such adhesions. This study aimed to evaluate the safety and anti-adhesive effect of an ADM in patients undergoing thyroid surgery.

Methods: In this multicenter randomized controlled trial, patients undergoing thyroid surgery were randomly assigned to receive either ADM (n = 42) or no ADM (n = 39) during surgery. The primary outcome was the Swallowing Impairment Score (SIS-6), measured 6 weeks after surgery and compared between groups. Secondary outcomes included intergroup comparisons of the SIS-6, the Voice Handicap Index (VHI)-10, and the Glasgow-Edinburgh Throat Scale (GETS) at baseline, and 2, 6, and 18 weeks after surgery.

Results: At week 6, the mean SIS-6 scores were 4.0 ± 4.1 and 3.3 ± 4.2 in the ADM and control groups, respectively, which was not significantly different. Both groups showed similar postoperative improvements in SIS-6, VHI-10, and GETS scores over time, without significant differences between groups at any time point, indicating that the ADM did not reduce the incidence of postoperative adhesions or alter the course of recovery compared to the control group.

Conclusion: Although application of the ADM is safe for use in patients undergoing thyroid surgery, it did not produce a clinically significant advantage in preventing postoperative adhesions. Future research should focus on identifying specific patient populations or surgical scenarios where the use of the ADM may be beneficial.

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来源期刊
CiteScore
2.30
自引率
7.10%
发文量
75
期刊介绍: Manuscripts to the Annals of Surgical Treatment and Research (Ann Surg Treat Res) should be written in English according to the instructions for authors. If the details are not described below, the style should follow the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publications available at International Committee of Medical Journal Editors (ICMJE) website (http://www.icmje.org).
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