Modified radical endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps

The Effect of Modified Radical Endoscopic Sinus Surgery on Chinese Patients With Eosinopilic Nasal Polyps

This study is testing a new type of sinus surgery to see if it can help people with chronic sinus issues and nasal polyps have fewer problems after surgery compared to the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT04852562 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of modified radical endoscopic sinus surgery in patients suffering from eosinophilic chronic rhinosinusitis with nasal polyps. The study aims to compare the outcomes of this more extensive surgical approach against traditional functional endoscopic sinus surgery. Patients will undergo surgery to remove mucosal tissue from the ethmoid and maxillary sinuses, with the goal of reducing postoperative polyp recurrence rates. The trial is prospective and randomized, ensuring a robust methodology for evaluating the intervention's impact.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18-65 diagnosed with eosinophilic chronic rhinosinusitis with nasal polyps who meet specific surgical criteria.

Not a fit: Patients outside the specified age range, those not diagnosed with eosinophilic chronic rhinosinusitis, or individuals who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of nasal polyps and improve quality of life for patients with severe eosinophilic inflammation.

How similar studies have performed: Previous studies have indicated that more radical surgical approaches can lead to better outcomes in similar patient populations, suggesting potential success for this trial.

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;

Where this trial is running

Wuhan, Hubei

• Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Zheng Liu, Doctor

Conditions Chronic Sinusitis; Endoscopic Sinus Surgery; Nasal Polyps; eosinophilic chronic rhinosinusitus with nasal polyps.; endoscopic sinus surgery