The Effect of Modified Radical Endoscopic Sinus Surgery on Chinese Patients With Eosinopilic Nasal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention
研究概览
简要总结
Functional endoscopic sinus surgery (FESS) is the pimary surgical treatment of CRS, characterized with the preservation of nasal structure and function.But the control of disease by surgery has been unsatisfactory. Recent studies have shown that patients with recurrent CRSwNP (usually with severe eosinophilic inflammation), more radical surgery may be more effective. The purpose of this prospective and randomized study is to determine the effect of endoscopic sinus surgery for extensive mucosal removal in patients with eosinophilic chronic rhinosinusitus with nasal polyps.
详细描述
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache. Patients with significant eosinophilic inflammation usually accompanied with a higher recurrence rate and more severe clinical symptoms. Endoscopic sinus surgery (ESS) is recommended to patients who do not response well to conservative treatments. A retrospective study showed that postoperative polyp recurrence rate of patients with severe eosinophilic inflammation was significantly reduced by rebooting sinus mucosa. In this study, the experimental group intends to adopt a modified radical surger to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate resection to achieve a extensive treatment of ethmoid sinus. Antrostomies of frontal and sphenoid sinuses were then performed with meticulous operation and preserve the mucosa intactly.
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
- •CRSwNP is diagnosed according to EPOS clinical guidelines and met surgical requirements, the blood eosinophil count was greater than 0.22;
- •Subjects/legal authorized representatives must understand the purpose and procedures of the study and voluntarily sign the informed consent, voluntarily participate in the study and comply with the study regulations, understand and comply with follow-up plan, and can correctly record the scale score, the administration frequency, accompanying drug use and adverse events, etc;
- •The examinee must be 18-65 years old, male or non pregnant female, limited to Chinese;
- •During the treatment and follow-up period, female subjects have no pregnancy and lactation plans;
- •The subjects did not participate in other clinical trials in the past three months and agreed not to participate in other clinical trials before reaching the end point of this trial;
- •Patients accompanying asthma must use their regular asthma treatment steadily in the past 6 weeks;
排除标准
- •Women must not be pregnant, or breast-feeding;
- •Subjects with cystic fibrosis, congenital ciliary dyskinesia, fungal sinusitis, systemic vasculitis and granulomatous disease, tumor, and immunodeficiency are exclued;
- •Subjects accpted nasal endoscopic surgery within 6 months are exclued;
- •Subjects with an upper respiratory tract infection within 4 weeks of entering the study are excluded;
- •Subjects with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis;
- •Currently participating in other clinical studies or in other clinical investigators within 30 days, or staff directly involved in this study;
- •Subjects with emotional or mental problems are excluded;
- •Subjects must not have received immunotherapy within the previous 3 months;
- •Subjects unsuitable for inclusion based on judgement of researchers are excluded;
结局指标
主要结局
Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention
时间窗: 1month, 3month, 6month, 12month
The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
次要结局
- Revision surgery rate(12month)
- Symptom duration(1month, 3month, 6month, 12month)
- Postoperative medication(1month, 3month, 6month, 12month)
- Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention(1month, 3month, 6month, 12month)
- Recurrence time(1month, 3month, 6month, 12month)
- Change from baseline at months 1, 3, 6 and 12 in visual analogue scale (VAS) after surgical intervention(1month, 3month, 6month, 12month)
研究者
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Huazhong University of Science and Technology