Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Postoperative Synerchia
研究概览
简要总结
Primary objective
- To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
- To validate the Thai version of disease-specific quality of life tool SNOT-22
Secondary objectives
- To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
- To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
- To compare the side effects of Mitomicin C versus placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All Thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for CRS
- •Patients must not have following diseases or conditions
- •Cystic fibrosis based on positive sweat test or DNA test
- •Gross immunodeficiency (congenital or acquired)
- •Congenital mucociliary problem (eg. Primary ciliary dyskinesia)
- •Altered immune function such as patients with systemic vasculitis, systemic lupus erythematosus, end stage renal disease, cirrhosis, currently taking immunosuppressant or granulomatous disease
- •Severe comorbidity with life expectancy of less than 1 year, such as advanced stage malignancy patient, or severe infection
- •Patients are willing to participate and provide written informed consent
排除标准
- 未提供
研究组 & 干预措施
Mitomicin C
Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side.
干预措施: Mitomicin C (Drug)
Placebo
Identical placebo solution
干预措施: Identical placebo solution (Drug)
结局指标
主要结局
Postoperative Synerchia
时间窗: 1 year
The primary outcome of interest is time to event, with the event as the occurrence of nasal synechia. The date of surgery will be used as the beginning date, and the last date will be the date that patient was defined as synechia, or the end of the study period if that patient does not have synechia on follow up.
次要结局
- Scoring of SNOT-22(1 year)
- Clinical Symptom Score(6 months)
- SNOT-22(6 months)