Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Post-operative recovery
研究概览
简要总结
Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis
详细描述
Extracapsular tonsillectomy (TE) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in Turku University Central Hospital, Finland.
In our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (SIPT) ) as the intervention group with extracapsular tonsillectomy as the control group.
SIPT is done with either coblation or microdebrider and TE with monopolar electrosurgery.
Indications for surgery are recurrent tonsillitis or chronic tonsillitis. The patient group is adults (16-65 years)
Safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.
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)
盲法说明
Patients are masked with numbers and patient records not shown to the outcomes assessor
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 16-65 years
- •Planned tonsil surgery with informed consent
- •Recurrent or chronic tonsillitis
排除标准
- •Less than 1 month old, drained quinsy
- •Acute "hot phase" tonsillitis
- •Previous palatine tonsil surgery
- •Suspicion or confirmation of malignancy
- •High dose analgesics consumption
- •Current CPAP-device usage for treatment of OSAS
- •Untreated gastro-esophageal reflux disease
- •Anticoagulative medication
- •Any condition of hemophilia
- •Pregnancy, lactation
- •Current or positive history of malignant disease (if still active follow-up)
研究组 & 干预措施
ICTE/Coblator
Intrapsular tonsillectomy (ICTE) with coblator
干预措施: tonsillectomy (Procedure)
ECTE/Electrosurgery
Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery
干预措施: tonsillectomy (Procedure)
ICTE/Microdebrider
Intracapsular tonsillectomy (ICTE) with microdebrider
干预措施: tonsillectomy (Procedure)
结局指标
主要结局
Post-operative recovery
时间窗: 21 days
Pain post-operatively after discharge as self-reported pain intensity over the past day. Each day is scored with the modified Brief Pain Inventory and recovery is achieved when pain score reaches preset values. Recovery speed defined as pain VAS-score 3 or less at rest; or pain VAS-score 5 or less without regular analgesics use. Daily questionnaire used: Brief Pain Inventory.
次要结局
- Revision surgery(5 years)
- Analgesics use(21 days)
- Post-operative bleeding(21 days)
- Life quality(6 months)
- Throat problems(5 years)
- Life Quality(6 months)
- Residual tonsil tissue(6 months)
研究者
Jaakko Piitulainen
Consultant
Turku University Hospital