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

Launched by ZHENG LIU · Apr 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a type of surgery called modified radical endoscopic sinus surgery to see how well it helps people with eosinophilic chronic rhinosinusitis with nasal polyps. This condition causes ongoing sinus issues and can lead to nasal polyps, which are growths in the nasal passages. The goal of the study is to find out if a more extensive approach to surgery can provide better relief for patients who have not responded well to standard treatments.

To participate in the trial, individuals need to be between 18 and 65 years old and diagnosed with the specific type of sinusitis mentioned. They should have a particular level of eosinophils in their blood, which are a type of white blood cell involved in inflammation. Participants will need to sign consent forms and will be closely monitored during the study. This trial is currently recruiting participants and is limited to individuals who have not been involved in other clinical studies recently. It's important for potential participants to be in good overall health, without serious underlying medical conditions that could interfere with the study.

Gender

ALL

Eligibility criteria

• 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, 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;