Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Number of sore throat episodes after TE vs. TO.
研究概览
简要总结
Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE.
Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain.
Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥15 years) with RT, defined as a minimum of five tonsillitis episodes in one year or a minimum of three tonsillitis episodes per year for two years (Danish National Guidelines criteria
- •The ability to understand Danish orally and in writing.
排除标准
- •Previous TE or TO.
- •Suspected tonsillar malignancy.
- •History of malignant tumor in the oral cavity, the pharynx or the larynx.
- •Previous radiation therapy on head or neck.
- •Hemorrhagic diathesis or anticoagulant therapy.
结局指标
主要结局
Number of sore throat episodes after TE vs. TO.
时间窗: 12 months (and 24, 36 and 60 months)
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO
时间窗: 12 months (and 24, 36 and 60 months)
A disease-specific questionnaire for adults with tonsillitis. It is used pre- and postoperatively to detect changes in quality of life. It consists of 14 questions that covers four subscales: throat dis-comfort (question 1-4) general health (question 5-6), resources (question 7-10), and social psychological restrictions (question 11-14). The questionnaire uses a six-point Likert scale with 0 representing "no problem" and 5 representing "couldn't be worse". The points are summed, divided by the number of questions multiplied by 5, and multiplied by 100, giving scores in the range 0-100, where higher scores reflect poorer quality of life
Summarized postoperative pain scores (days 1-10)
时间窗: Days 1-10
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"
Overall postoperative discomfort (day 21)
时间窗: Day 21
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"
次要结局
- Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO(12 months (and 24, 36 and 60 months))
- Overall patient satisfaction after TE vs. TO(12 months (and 24, 36 and 60 months))
- Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO(12 months (and 24, 36 and 60 months))
- Number of sore throat days after TE vs. TO(12 months (and 24, 36 and 60 months))
- Prevalence of reoperation after TE vs. TO(12 months (and 24, 36 and 60 months))
研究者
Tejs Ehlers Klug
MD, DMSc, Clinical Associate Professor
Aarhus University Hospital