A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Sinonasal Outcome Test-22 score
研究概览
简要总结
The aim of this study is to find out if endoscopic sinus surgery improves the quality of life in patients suffering from recurrent acute rhinosinusitis. Our main outcome is the difference between the average change in disease-specific SNOT-22 quality of life questionnaire scores (from baseline to 5-6 months follow-up) between the intervention and the control groups.
详细描述
This is a randomized controlled trial. Patients suffering from recurrent acute sinusitis episodes will be randomly allocated to two groups: intervention group, where they will receive endoscopic sinus surgery in addition to medical treatment and control group, where they will receive mere medical treatment. Both groups will be followed-up for 5 to 6 months. At baseline and after 5 to 6 months, patients will answer the life quality questionnaires SNOT-22 and RAND 36-item Health Survey. The numbers of sinusitis episodes, medical appointments for respiratory symptoms, use of medications, numbers of days lost from work or studies and numbers of days with various respiratory and adverse symptoms will be recorded with patient diaries. The potential serious adverse events (e.g. cerebrospinal fluid leak, orbital complications) related to surgery will be collected from the medical records.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months or at least 2 episodes per year for 3 consecutive years
- •Episodes must last less than 4 weeks and be diagnosed and treated as acute rhinosinusitis by a physician
- •Episode symptoms include nasal discharge, nasal congestion, hyposmia and facial pressure or pain and the episodes have to be severe enough for the patient to seek medical help and for daily life to be significantly disturbed
- •Patients must have failed a three-month conservative therapy (medication for possible allergies, nasal corticosteroids and douching and courses of antibiotics as necessary)
排除标准
- •Age under 18 years,
- •Immunodeficiency or immunosuppression
- •Pregnancy,
- •Previous illness making same-day surgery unfeasible
- •Ongoing antibiotic treatment for other reasons,
- •Primary complaint of nasal septal deviation and
- •Chronic rhinosinusitis with or without nasal polyposis
- •Symptoms for over 12 weeks and/or Lund-Mackay score over 8 in paranasal sinus CBCT scanning
结局指标
主要结局
Sinonasal Outcome Test-22 score
时间窗: 5-6 months
Difference between the mean disease-specific Sinonasal Outcome Test 22 (SNOT-22) change scores (from baseline to 5-6 months) of ESS and control group. SNOT-22 summary scores vary between 0 and 110 with higher values indicating poorer quality of life.
次要结局
- Difference in numbers of days with nasal discharge(5-6 months)
- Difference of numbers of days with fever(5-6 months)
- Adverse effects - postoperative synechia formation(5-6 months)
- Difference in numbers of days with facial pain or pressure(5-6 months)
- Adverse effects - postoperative orbital complication(5-6 months)
- Difference in numbers of sinusitis episodes(5-6 months)
- Adverse effects - postoperative infection(5-6 months)
- Difference in proportions of patients benefiting(5-6 months)
- Difference in numbers of antimicrobial treatments(5-6 months)
- Difference in numbers of days with nasal obstruction(5-6 months)
- Difference in numbers of days with nasal pain(5-6 months)
- Difference in numbers of days with nasal hemorrhage(5-6 months)
- 36-Item Short Form Survey (SF-36, RAND) score(5-6 months)
- Difference in numbers of medical visits(5-6 months)
- Difference in numbers of days lost from work or studies(5-6 months)
- Adverse effects - postoperative intracranial complication(5-6 months)
研究者
Olli-Pekka Alho, MD
Professor of Otorhinolaryngology
Oulu University Hospital