Status:
COMPLETED
The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps
Lead Sponsor:
Zheng Liu
Collaborating Sponsors:
Wuhan Central Hospital
Wuhan No.1 Hospital
Conditions:
Chronic Sinusitis
Endoscopic Sinus Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 u...
Detailed Description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, an...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
Key Trial Info
Start Date :
December 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04852562
Start Date
December 6 2020
End Date
July 26 2024
Last Update
September 10 2025
Active Locations (1)
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1
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030