Surgery for severe nasal polyps in chronic sinusitis
Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
NA · Tanta University · NCT05979662
This study is testing if a specific type of sinus surgery can help people with severe nasal polyps and chronic sinusitis feel better and reduce the chances of polyps coming back.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 2 sites (Tanta, El-Gharbia and 1 other locations) |
| Trial ID | NCT05979662 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endoscopic frontal sinus surgery (Draf III) in patients suffering from moderate to severe eosinophilic chronic rhinosinusitis with nasal polyps. The primary focus is on measuring the recurrence of polyps post-surgery using an endoscopic polyp score, while secondary outcomes include assessing overall sinus health through Lund MacKay scores, quality of life via SNOT-22, and the need for corticosteroids after the procedure. The study aims to provide insights into surgical outcomes for a condition that significantly impacts patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate to severe eosinophilic chronic rhinosinusitis with polyps who have not responded to medical treatments.
Not a fit: Patients with contraindications for general anesthesia, those under 18 years old, or those with previous sinus surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this surgery could significantly reduce polyp recurrence and improve the quality of life for patients with severe eosinophilic chronic rhinosinusitis.
How similar studies have performed: Previous studies have shown that surgical interventions for chronic rhinosinusitis can lead to improved outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months . Exclusion Criteria: * Narrow anteroposterior diameter of frontal sinus ostium(1cm or less) * Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography. * Any contraindication for general anesthesia. * Patients below age of 18 years. * Incomplete follow up * previous sinus surgery
Where this trial is running
Tanta, El-Gharbia and 1 other locations
- Tanta University Hospitals — Tanta, El-Gharbia, Egypt (RECRUITING)
- Tanta University — Tanta, El-Gharbia, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ibrahim T Elshamy, MSc
- Email: hematalal93@gmail.com
- Phone: +20 102 237 3920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III, Draf I or IIa