氧化纤维素粉及内镜下涂抹器在多中心试验中的临床评价。

Petr Habal, Veronika Sívková, Zdeněk Šorm, Milan Chobola, Jiří Feix, Igor Slaninka, Jiřina Habalová, Tomáš Hosszú, Jaroslav Pacovský
{"title":"氧化纤维素粉及内镜下涂抹器在多中心试验中的临床评价。","authors":"Petr Habal, Veronika Sívková, Zdeněk Šorm, Milan Chobola, Jiří Feix, Igor Slaninka, Jiřina Habalová, Tomáš Hosszú, Jaroslav Pacovský","doi":"10.14712/18059694.2025.13","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Oxidized cellulose-based haemostatic agents are widely used for managing bleeding in various surgical procedures. This study evaluates the efficacy and safety of oxidized cellulose powder and an endoscopic applicator across a broad spectrum of surgical settings.</p><p><strong>Methods: </strong>This was a prospective, multicentre study involving 99 evaluable patients undergoing surgeries with varying bleeding severities and surgical approaches (open, laparoscopic, or thoracoscopic). The primary endpoint was achieving haemostasis within 3 minutes and avoiding revision surgery within 12 hours. The time to haemostasis (TTH) and complications were recorded, and statistical comparisons were made using a paired and unpaired t-test, with a significance threshold of P < 0.05. Data from this study were compared to historical results from fibrillar haemostats.</p><p><strong>Results: </strong>Haemostasis was achieved within 3 minutes in 61.6% (95% CI [52.0, 71.2]) of patients and within 5 minutes in 99.0% (95% CI [97.0, 100.0]) of patients. The overall mean TTH was 153.8 seconds (95% CI: 141.5-166.1), with shorter TTH observed in minimally invasive procedures using the endoscopic applicator. Subgroup analysis revealed higher success rates for patients with mild bleeding (78%) compared to moderate bleeding (50%).</p><p><strong>Conclusion: </strong>Oxidized cellulose powder demonstrates reliable haemostatic performance across diverse surgical applications. The endoscopic applicator enhances precision and applicability, particularly in minimally invasive settings, making it a valuable tool in modern surgical practice.</p>","PeriodicalId":101400,"journal":{"name":"Acta medica (Hradec Kralove)","volume":"68 1","pages":"14-20"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial.\",\"authors\":\"Petr Habal, Veronika Sívková, Zdeněk Šorm, Milan Chobola, Jiří Feix, Igor Slaninka, Jiřina Habalová, Tomáš Hosszú, Jaroslav Pacovský\",\"doi\":\"10.14712/18059694.2025.13\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Oxidized cellulose-based haemostatic agents are widely used for managing bleeding in various surgical procedures. This study evaluates the efficacy and safety of oxidized cellulose powder and an endoscopic applicator across a broad spectrum of surgical settings.</p><p><strong>Methods: </strong>This was a prospective, multicentre study involving 99 evaluable patients undergoing surgeries with varying bleeding severities and surgical approaches (open, laparoscopic, or thoracoscopic). The primary endpoint was achieving haemostasis within 3 minutes and avoiding revision surgery within 12 hours. The time to haemostasis (TTH) and complications were recorded, and statistical comparisons were made using a paired and unpaired t-test, with a significance threshold of P < 0.05. Data from this study were compared to historical results from fibrillar haemostats.</p><p><strong>Results: </strong>Haemostasis was achieved within 3 minutes in 61.6% (95% CI [52.0, 71.2]) of patients and within 5 minutes in 99.0% (95% CI [97.0, 100.0]) of patients. The overall mean TTH was 153.8 seconds (95% CI: 141.5-166.1), with shorter TTH observed in minimally invasive procedures using the endoscopic applicator. Subgroup analysis revealed higher success rates for patients with mild bleeding (78%) compared to moderate bleeding (50%).</p><p><strong>Conclusion: </strong>Oxidized cellulose powder demonstrates reliable haemostatic performance across diverse surgical applications. The endoscopic applicator enhances precision and applicability, particularly in minimally invasive settings, making it a valuable tool in modern surgical practice.</p>\",\"PeriodicalId\":101400,\"journal\":{\"name\":\"Acta medica (Hradec Kralove)\",\"volume\":\"68 1\",\"pages\":\"14-20\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta medica (Hradec Kralove)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14712/18059694.2025.13\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta medica (Hradec Kralove)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14712/18059694.2025.13","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

目的:氧化纤维素基止血剂广泛用于各种外科手术中出血的处理。本研究评估了氧化纤维素粉和内窥镜应用器在广泛手术环境中的有效性和安全性。方法:这是一项前瞻性、多中心研究,涉及99例可评估的接受不同出血严重程度和手术方式(开放、腹腔镜或胸腔镜)手术的患者。主要终点是在3分钟内止血,并在12小时内避免翻修手术。记录止血时间(TTH)及并发症,采用配对和非配对t检验进行统计学比较,P < 0.05为显著性阈值。将本研究的数据与纤维状止血仪的历史结果进行比较。结果:61.6% (95% CI[52.0, 71.2])的患者在3分钟内止血,99.0% (95% CI[97.0, 100.0])的患者在5分钟内止血。总体平均TTH为153.8秒(95% CI: 141.5-166.1),在使用内窥镜应用器的微创手术中观察到的TTH更短。亚组分析显示,轻度出血患者的成功率(78%)高于中度出血患者(50%)。结论:氧化纤维素粉在多种外科应用中表现出可靠的止血性能。内镜应用器提高了精度和适用性,特别是在微创设置中,使其成为现代外科实践中有价值的工具。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial.

Purpose: Oxidized cellulose-based haemostatic agents are widely used for managing bleeding in various surgical procedures. This study evaluates the efficacy and safety of oxidized cellulose powder and an endoscopic applicator across a broad spectrum of surgical settings.

Methods: This was a prospective, multicentre study involving 99 evaluable patients undergoing surgeries with varying bleeding severities and surgical approaches (open, laparoscopic, or thoracoscopic). The primary endpoint was achieving haemostasis within 3 minutes and avoiding revision surgery within 12 hours. The time to haemostasis (TTH) and complications were recorded, and statistical comparisons were made using a paired and unpaired t-test, with a significance threshold of P < 0.05. Data from this study were compared to historical results from fibrillar haemostats.

Results: Haemostasis was achieved within 3 minutes in 61.6% (95% CI [52.0, 71.2]) of patients and within 5 minutes in 99.0% (95% CI [97.0, 100.0]) of patients. The overall mean TTH was 153.8 seconds (95% CI: 141.5-166.1), with shorter TTH observed in minimally invasive procedures using the endoscopic applicator. Subgroup analysis revealed higher success rates for patients with mild bleeding (78%) compared to moderate bleeding (50%).

Conclusion: Oxidized cellulose powder demonstrates reliable haemostatic performance across diverse surgical applications. The endoscopic applicator enhances precision and applicability, particularly in minimally invasive settings, making it a valuable tool in modern surgical practice.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信