Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 464
- 主要终点
- Postoperative pain
研究概览
简要总结
The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Tonsil size 2, 3, or 4 (Friedman tonsil scale)
- •Confirmed OSA with sleep analysis not older than a year either CRM or PSG
- •ASA 1 or 2
- •BMI < 35 kg/m2
排除标准
- •Children age < 18 years
- •Previous pharyngeal surgery such as previous tonsillotomy, tonsillectomy or palatal surgery
- •Epileptic disease or severe neurological comorbidity.
- •ASA 3, or
- •Central sleep apnea
- •Previous thrombotic disease.
- •Currently treated with sleep medications
- •No collapse of oropharyngeal lateral wall during DISE
- •Dropout of study, lack of sleep analysis or lack of postoperative DISE.
研究组 & 干预措施
Tonsillectomy
Patients undergo standard removal of subcapsular removal of palatine tonsils
干预措施: Tonsillectomy (Procedure)
Tonsillotomy
Patients undergo intracapsular reduction of palatine tonsils
干预措施: Tonsillotomy (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 30 days
Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.
Recovery time - Sick leave
时间窗: 30 days
Sick-leave in days, measured when the patient is at work or back at school, day 0 = surgery day and outcome day is last day of sick-leave
Morbidity
时间窗: 30 days
Re-admission at the hospital. Event is registered as null if no re-admission occurs and 1 or 2 etc. if re-admission occurs within first 30 days after surgery
Postoperative hemorrhage
时间窗: 14 days
Postoperative hemorrhage event - readmission to the hospital
次要结局
- AHI(180 days)
- DISE - VOTE(180 days)