A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- needle aspirations
研究概览
简要总结
The study is a prospective randomized controlled trial conducted at two different centers at the Department of ORL - Head & Neck Surgery, Odense University Hospital and the Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet.
The research question is:
In a group of patients referred to an otolaryngology department with objective findings of peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and guide needle aspiration compared to the traditional landmark-based technique, when measured by the number of performed needle aspirations, procedure-related pain and days on sick leave?
The secondary outcomes measured are
- Number of hospitalization days
- Number of Quincy tonsillectomies
- Number of visits to an outpatient clinic
- Patient-reported outcome (measured using an 11-point numeric rating scale)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
The landmark technique
PTA a needle aspiration attempted according to the landmark technique is conducted. If the initial aspiration is unsuccessful, two additional attempts are made in the middle and lower pole of the tonsil.
干预措施: The landmark technique (Procedure)
Ultrasound-guided aspiration
An intraoral ultrasound is conducted with a Burr-Hole N11C5s transducer (BK Ultrasound) and if an abscess cavity is suspected, an ultrasound-guided aspiration is performed with an in-plane needle guide attached to guide the needle.
干预措施: Intraoral ultrasound (Diagnostic Test)
结局指标
主要结局
needle aspirations
时间窗: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
total number of needle aspirations performed
proportion of succesfull needle aspirations
时间窗: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
proportion of needle aspirations with aspiration of pus
days on sick leave
时间窗: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Total number of days on sick leave after first intervention
次要结局
- Number of hospitalization days(From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.)
- Patient-reported outcome(From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.)
- Number of visits in outpatient clinic(Until full recovery from peritonsilar infection)
- Number of quincy tonsillectomies(From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.)
研究者
Tobias Todsen
MD, PhD
Rigshospitalet, Denmark