CompletedNot Applicable

The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps

China110 participantsStarted 2020-12-06

Plain-language 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 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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, n…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention

Timeframe: 1month, 3month, 6month, 12month

Trial details

NCT IDNCT04852562

SponsorZheng Liu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-26

View on ClinicalTrials.gov More Chronic Sinusitis trials