NCT04314492已完成不适用
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation
详细描述
The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 16-64
- •Planned tonsil surgery with informed concent
- •Obstructive sleep apnea (AHI > 15)
- •Tonsillar size of 3-4 on the Friedman scale
排除标准
- •BMI > 35 (Based on finnish Käypä Hoito -recommendations)
- •Central sleep apnea
- •Weight loss of more than 10% within the study period
- •Untreated obstruction of nasal breathing
- •Treated peritonsillar abscess <1 month before enrollment
- •Active tonsillar infection
- •Previous tonsillar surgery (excluding incision of abscess)
- •Malignancy
- •High use of analgesics >1 DDD daily during last 4 weeks
- •Untreated reflux
- •Anticoagulative medication
- •Any condition of hemophilia
- •Pregnancy, lactation
- •Other, evaluated by treating physician
研究组 & 干预措施
Intracapsular tonsillectomy with coblation
Experimental
(Total) Intracapsular tonsillectomy (ICTE) with coblation
干预措施: Tonsillectomy (Procedure)
结局指标
主要结局
Apnea-hypopnea index
时间窗: 6 months
Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.
次要结局
- Quality of life measured by Glasgow Benefit Inventory(6 months and 24 month and 60 months)
- Quality of life measured by Nordic tonsil surgery register questionnaire(6 months - up to 5 years)
- Total recovery of obstructive sleep apnea(6 months and 24 months and 60 months)
- Quality of life measured by Epworth sleepiness scale(6 months - up to 5 years)
- Post-operative recovery(21 days)
- Snoring time(6 months and 24 months and 60 months)
- Regrowth of tonsillar tissue(Pre-operative to 6 months)
- Apnea-index(6 months and 24 months and 60 months)
研究者
Jaakko Piitulainen
Consultant, Doctor of Medical Science
Turku University Hospital
研究点 (2)
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