Treatment of Tonsillar Abscess: A Randomized Clinical Trial in a Tertiary Center
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Proportion of treatment success (%)
研究概览
简要总结
The diagnosis and treatment of tonsillar abscess are very physician-dependent, as sufficient prospective medical literature is lacking to choose the most efficient regimen. The proposed study aims to assess the therapeutic efficacy of tonsillectomy compared to drainage under local anesthesia. This is a prospective, randomized clinical trial in adults in a tertiary care center in Geneva (Switzerland).
详细描述
Introduction:
Tonsillar abscess is the most common complication of acute bacterial angina. The abscess is located in the majority of cases in the capsular space and occasionally within the tonsil itself. The ethiopathogenesis is polymicrobial, composed mainly of Streptococcus Pyogenes (aerobic) and Fusobacterium Necrophorum (anaerobe). This condition mainly affects young adults, smokers and significantly impacts quality of life. Symptoms are noisy, characterized by severe odynodysphagia, often limited mouth opening (trismus), and occasionally dyspnea, fever, and decreased general condition. Its complications include upper airway obstruction, spread of infection into the deep tissues of the neck and mediastinum, septic venous thrombosis, and arterial hemorrhage from contact necrosis. The descriptions of the management of this pathology are centuries old, but even today there is a need to drain the pus. We estimate that around 200 patients per year present to our University Hospital in Geneva (Switzerland) with suspected tonsillar abscess.
Diagnosis:
The medical literature describes several diagnostic methods without clear consensus on the most effective. The doctor's clinical suspicion varies according to the examiner's experience, although certain criteria are recognized as good predictors of the presence of an abscess (trismus, edema, uvula deviation, "hot potato voice", reflex otalgia), but with limited sensitivity and specificity. When clinically suspected, confirmation of the presence of pus can be determined by direct puncture or drainage, allowing immediate diagnosis, but with a high proportion of false negatives and requiring a painful invasive procedure. Ultrasound (US) and Computed Tomography (CT) provide a painless diagnosis, but US requires a specific oral probe and may be unfeasible in case of trismus, and its interpretation is very examiner-dependent. CT remains an irradiating, costly and time-consuming exam, but it is sensitive and can formally exclude any associated complication (venous thrombosis, retro- or parapharyngeal extension, contralateral involvement). The gold-standard for the diagnosis of a tonsillar abscess is the direct visualization of pus during drainage.
Treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age with clinical suspicion of unilateral tonsillar abscess without signs of "extra-capsular" complication.
- •Obtaining informed consent.
排除标准
- •Contraindications to injected CT or drainage in local anesthesia (allergy to iodinated contrast product, allergy to local anesthetics, phobia of needles, major trismus).
- •Parapharyngeal or retropharyngeal abscess, or associated venous thrombosis found on CT.
- •Imminent threat to the upper respiratory tract (glottic edema, acute dyspnea).
- •Inability to understand the different procedures (dementia, impossible communication, substance abuse).
- •Anamnestic pregnancy.
- •Antiaggregant or anticoagulant treatment.
- •Treatment of corticosteroids during the management of emergencies and in hospital.
研究组 & 干预措施
Incision drainage
Adult with clinical suspicion of tonsillar abscess who underwent a CT-scan confirming the abscess will be randomly assigned to one arm or the other. "Incision drainage" arm will benefit from drainage of the tonsillar abscess under local anesthesia and then be hospitalized for intravenous antibiotics. If the incision drainage fails, they will get a tonsillectomy under general anesthesia.
干预措施: Incision drainage (Procedure)
Tonsillectomy
Adult with clinical suspicion of tonsillar abscess who underwent a CT-scan confirming the abscess will be randomly assigned to one arm or the other. "Tonsillectomy" arm will benefit from tonsillectomy under general anesthesia and then be hospitalized for intravenous antibiotics.
干预措施: Tonsillectomy (Procedure)
结局指标
主要结局
Proportion of treatment success (%)
时间窗: 3 days
Disappearance of fever if any + decrease in leukocytosis and CRP value + no sign of recollection nor cervical extension of the infection.
次要结局
- Recurrence rate (%)(3 and 12 months)
研究者
François Voruz
Principal investigator
University Hospital, Geneva
