NCT05880134

Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing conventional posterior nerve neurectomy in Neurectomy in 150 participants. Completed in 30 November 2023.

Timeline

12 March 2022

Primary endpoint
30 May 2023

30 November 2023

Quick facts

Lead sponsor	Kafrelsheikh University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	12 March 2022
Primary completion	30 May 2023
Estimated completion	30 November 2023
Sites	1 location across Egypt

Drugs / interventions tested

• conventional posterior nerve neurectomy
• cartilage graft reinforcement after posterior nerve neurectomy

Conditions studied

• Neurectomy — all drugs for Neurectomy →

Sponsor

Kafrelsheikh University

Who can join

Eligibility, any sex, with Neurectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rhinitis is defined clinically as having two or more symptoms of anterior or posterior rhinorrhea, sneezing, nasal blockage and/or itching of the nose during two or more consecutive days for more than 1 h on most days.

Allergic rhinitis is diagnosed when these symptoms are caused by allergen exposure leading to an IgE mediated reaction. The inflammatory mediators produced because of this IgE mediated reaction causes the classical symptoms of allergic rhinitis.

Nerve irritation causes sneezing and itching, the loss of mucosal integrity causes rhinorrhea, and the vascular engorgement leads to nasal blockage.

Based on the nasal symptoms the prevalence of allergic rhinitis in the Indian population is 20-30%.

Allergic rhinitis significantly affects the quality of life, it contributes to missed or unproductive time at school or work, disturbed sleep pattern and daytime somnolence.

The most popular and widely accepted treatment strategy for allergic rhinitis is pharmacotherapy, this includes antihistamines, leukotriene receptor antagonist and intranasal corticosteroids. These medical modalities are symptomatically effective in mild cases, with temporary relief and addressable adverse effects. Prolonged treatment with allergy immunotherapy causes a sustainable financial burden while remaining inaccessible at smaller towns.

Rhinorrhea is a frequent symptom reported amongst patients with allergic and vasomotor rhinitis. Most of these patients usually respond well to medical treatment.

Indications for surgical treatment are warranted only when medical treatment fails, or a patient wants a permanent solution.

In 1961, Golding-Wood first described vidian neurectomy for the treatment of allergic and vasomotor rhinitis. There was a high incidence of post-operative complications, such as disturbed lacrimal secretion and numbness of the cheek and gums. In 2007, Kikawada reported an endoscopic technique involving resection of the posterior nasal nerve near the sphenopalatine artery. With this technique, any intra-operative bleeding can be controlled under direct vision. In 2008, Ikeda et al. described submucosal reduction of the inferior turbinate and resection of the posterior nasal nerve. This resulted in significant improvements in nasal symptoms for patients with resistant chronic rhinitis (rhinorrhea).

The posterior nasal nerve is a peripheral branch of the sphenopalatine ganglion. It enters the nasal cavity through a separate foramen, 4-5 mm below the sphenopalatine foramen, after bifurcation of the nerve into the lacrimal nerve. The posterior superior nasal nerves innervate the superior and middle turbinates, and the superior and middle meatus.

Other parasympathetic nerve fibres of the nose branch off and joins the greater palatine nerve and enters the nasal cavity through the canaliculi in the perpendicular plate of the palatine bone as the posterior inferior nasal nerves. These nerves innervate the inferior turbinate and the inferior meatus.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.