- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06887842
Posterior Nasal Nerve Neurectomy for Treatment of Intractable Allergic Rhinitis
May 17, 2026 updated by: Ahmed Magdi Noaman Othman Orabi, Kafrelsheikh University
Posterior Nasal Nerve Surgical Resection Versus Radiofrequency Ablation Versus Surface Coblation for Treatment of Intractable Allergic Rhinitis
This study aims to compare the outcomes of posterior nasal nerve neurectomy in patients with resistant Allergic rhinitis by using three different methods ( surgical resection vs radiofrequency ablation vs surface coblation ) through assesment of functional outcomes, postoperative complications, and impacts on quality of life.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kafrelsheikh, Egypt
- Kafrelsheikh University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 16 to 65 years, fit for surgery, diagnosed as moderate to severe persistent Allergic Rhinitis, as per the ARIA guidelines having 3 or more of the typical symptoms of Allergic Rhinitis including nasal discharge, repeated attacks of sneezing, nasal itching and nasal obstruction.
Exclusion Criteria:
• Patients with Coexisting nasal pathologies that could influence the outcomes of the surgery like: chronic granulomatous diseases of the nose, nasal tumors, chronic sinsitis with or without nasal polyps, etc.
- Patients who had used topical steroid nasal spray, oral or topical antihistamines, oral leukotriene antagonists, oral or tobical nasal decongestants in the last 2 weeks.
- Immunocompromised patients, Systemic disease affecting prognosis such as diabetes mellitus, hypertension,chronic liver failure or heart failure.
- Unwillingness for endoscopic surgery.
- Patients younger than 18 years of age.
- Patients who are unfit for general anesthesia.
- Previous history of nasal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Posterior nasal neurectomy by surgical resection
|
Posterior Nasal Nerve neurectomy which is done by surgical resection.
Posterior Nasal Nerve neurectomy which is done by using radiofrequency ablaion.
Posterior Nasal Nerve neurectomy by coblation of the surface of the course of the nerve
|
|
Active Comparator: Posterior nasal neurectomy by radio- frequency ablation
|
Posterior Nasal Nerve neurectomy which is done by surgical resection.
Posterior Nasal Nerve neurectomy which is done by using radiofrequency ablaion.
Posterior Nasal Nerve neurectomy by coblation of the surface of the course of the nerve
|
|
Active Comparator: Surface coblation on area of the course of the Posterior nasal nerve
|
Posterior Nasal Nerve neurectomy which is done by surgical resection.
Posterior Nasal Nerve neurectomy which is done by using radiofrequency ablaion.
Posterior Nasal Nerve neurectomy by coblation of the surface of the course of the nerve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of the four main symptoms (Sneezing ,itching , rhinorrhea ,nasal obstruction)
Time Frame: Evaluations will be scheduled for 2 weeks, one month, three months, and six months following surgery.
|
These symptoms will be assessed using the SNOT-22 rhinologic subdomain questionnaire which is routinely and prospectively administered to all patients, and individual item scores within the rhinologic subdomain (need to blow nose, sneezing, runny nose, cough, post- nasal discharge, and thick nasal discharge) will be tabulated, each symptom will be scored on a scale from 0 to 5 (0 = no problem, 1 = very mild problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem and 5 = problem as bad as it can be).
|
Evaluations will be scheduled for 2 weeks, one month, three months, and six months following surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative complications eg. Bleeding, crustations etc, postoperative endoscopic score will be evaluated.
Time Frame: 2 weeks, 1M month after the procedure .
|
Bleeding assessment using The Modena bleeding score.
Postoperative endoscopic score including : (discharge, crust formation ,scarring ) after the operation will be also recorded and documented using the LundKennedy (LK) system.
|
2 weeks, 1M month after the procedure .
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2025
Primary Completion (Actual)
April 10, 2026
Study Completion (Actual)
May 1, 2026
Study Registration Dates
First Submitted
March 9, 2025
First Submitted That Met QC Criteria
March 14, 2025
First Posted (Actual)
March 20, 2025
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 17, 2026
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-543
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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