扁桃体切除术和扁桃体切除术后出血的风险-一项随机临床试验的方案。

IF 1 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL
Danish medical journal Pub Date : 2023-05-23
Michael F Howitz, Frej Juul Vilhelmsen, Kasper Wennervaldt, Valdemar Trolle, Malene Kirchmann
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引用次数: 0

摘要

扁桃体切除术是耳鼻喉领域最常见的手术之一,2012年,7.7%的丹麦人在20岁之前接受了扁桃体切除术。一个令人担忧的并发症是扁桃体切除术后出血(PTH),丹麦的一项基于登记的研究发现,这种情况从1991年的3%增加到2012年的13%。甲状旁腺激素具有显著的风险,文献中有死亡报道。该试验的目的是比较扁桃体切除术期间的冷热止血和评估,首先,甲状旁腺激素的风险,其次,报告的痛感。方法:这是一项单中心、双臂、干预性随机对照试验。该研究的目标患者> 12岁转介扁桃体切除术。参与者将切除两个扁桃体;一侧进行冷止血,另一侧进行热疗止血。参与者随后将在一个月内收到三份关于出血发作和疼痛感知的问卷。由于这项研究的设计,病人和外科医生作为自己的对照。结论:本研究结果可指导今后扁桃体切除术降低甲状旁腺风险的研究和实践。资助:Lizzi and Mogens Staal Fonden和Nordsjællands医院。资金来源对试验设计、数据收集、分析或发表没有影响。试验注册:Clinicaltrials: gov标识符:NCT05161754。注册日期:20042021;版本2:20042021。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tonsillectomy and risk of post-tonsillectomy haemorrhage - a protocol for a randomised clinical trial.

Introduction: Tonsillectomy is one of the most common procedures in the ear, nose and throat field, and 7.7% of the Danish population had undergone a tonsillectomy by the age 20 years in 2012. One feared complication is post-tonsillectomy haemorrhage (PTH), which in a Danish register-based study was found to increase from 3% in 1991 to 13% in 2012. PTH represents a significant risk and deaths are reported in the literature. The aim of the trial is to compare hot and cold haemostasis during tonsillectomy and assess, firstly, the risk of PTH and, secondly, the reported pain perception.

Methods: This is a single-centre, two-arm, interventional randomised controlled trial. The study targets patients > 12 years of age referred for tonsillectomy. Participants will have both tonsils removed; on one side cold haemostasis will be performed and on the other hot diathermia will secure haemostasis. The participants will subsequently receive three questionnaires in the course of a month concerning bleeding episodes and pain perception. Owing to the study design, patients and surgeons act as their own controls.

Conclusions: The results of the study may guide future research and practice of tonsillectomy to reduce the risk of PTH.

Funding: Lizzi and Mogens Staal Fonden and Nordsjællands Hospital. The funding sources had no influence on trial design, data collection, analysis or publication.

Trial registration:

Clinicaltrials: gov Identifier: NCT05161754. Registration date: 20042021; version 2: 20042021.

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来源期刊
Danish medical journal
Danish medical journal MEDICINE, GENERAL & INTERNAL-
CiteScore
2.30
自引率
6.20%
发文量
78
审稿时长
3-8 weeks
期刊介绍: The Danish Medical Journal (DMJ) is a general medical journal. The journal publish original research in English – conducted in or in relation to the Danish health-care system. When writing for the Danish Medical Journal please remember target audience which is the general reader. This means that the research area should be relevant to many readers and the paper should be presented in a way that most readers will understand the content. DMJ will publish the following articles: • Original articles • Protocol articles from large randomized clinical trials • Systematic reviews and meta-analyses • PhD theses from Danish faculties of health sciences • DMSc theses from Danish faculties of health sciences.
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