Recurrent Throat Infections and Tonsillectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)
研究概览
简要总结
The purpose of this study is to find out if tonsillectomy reduces the short-term risk of having an objectively confirmed (sequential changes in serum crp and procalcitonin levels) delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes. Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the quality of life after tonsillectomy among these patients are examined.
详细描述
We will have a prospective randomized study. We allocated 87 consecutive patients referred for tonsillectomy randomly in two groups: tonsilectomy group or waiting list(control group). Patients in tonsillectomy group were operated as soon as possible and data on postoperative morbidity was collected. In the control group, patients were placed on our normal waiting list and they were operated on in normal time (about 5-6 months). The data on preoperative morbidity was collected. All the pharyngitis episodes were treated by a study investigator and laboratory tests (crp, procalcitonin) were taken at that time and after three days. In addition, the patients record their symptoms on a diary.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients selected among the cases referred to tonsillectomy for recurrent pharyngitis episodes to a tertiary care university ENT clinic (Oulu, Finland).
- •At least three pharyngitis episodes difficult enough for the patients to seek for medical attention during the past 12 months
排除标准
- •Patients with other serious diseases (day surgery not feasible)
- •Patients having long time antibiotic treatment for other disease
- •Patients diagnosed to have peritonsillar abscess
- •Pregnancy
- •Age of 12 or under
- •Patients living outside Oulu or its 8 neighbouring cities (day surgery not feasible)
- •Patients suffering only from halitosis or bacterial plugs of palatine tonsils
结局指标
主要结局
Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin)
时间窗: 5 months follow up
次要结局
- Absolute percentage difference of patients having group A streptococcal pharyngitis.(5 months follow up)
- Absolute percentage difference of patients having acute pharyngitis episode with and without medical consultation(5 months follow up)
- Difference in the number and quality (mild, severe) of symptomatic days (fever, sore throat, rhinitis, cough)(5 months follow up)
- Absolute percentage difference having harmful effects related to tonsillectomy (haemorrhage, soft tissue burns etc.)(5 months follow up)