Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880134
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-03-16
Brief Title:
Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Cartilage Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rhinitis is defined clinically as having two or more symptoms of anterior or posterior rhinorrhea sneezing nasal blockage andor 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
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
Detailed Description:
Allergic rhinitis AR is a growing health problem all over the world Around the world more than 500million subjects complained of AR and its prevalence had been increased during the last decades AR affected approximately 113 million people in Europe and about 30 - 60 million in the United States Poorly controlled symptoms of AR could lead to different comorbidities eg impaired sleep with consequent daytime fatigue which affect overall patients work or school achievement all affect quality of life QoL with increased treatment costs The ideal treatment strategy of AR includes complete avoidance of allergens local corticosteroids leukotriene receptor antagonists Th2 cytokine suppressors and nasal antihistamines therapy However these therapeutic interventions show limited effectiveness and high cost of long-term treatment Allergic rhinitis resistant to drug therapy usually submitted to posterior nasal nerve resection This surgical maneuver was originated from Vidian neurectomy which markedly reduces hypersecretion and hypersensitivity by ablation of the Vidian nerve with a transantral approach However Vidian neurectomy is occasionally accompanied by permanent comorbidities eg reduced lacrimation and development of upper lip numbness Posterior nasal neurectomy is a novel alternative technique in which neural bundles - under direct vision- are selectively cut or cauterized at the sphenopalatine foramen This enables avoidance of surgical compilations especially reduced lacrimation However literature is not yet addressed its safety and efficacy and no final consensus or guidelines had been drawn In addition it is of most importance to present our clinical experience and share our results regarding such procedure with the scientific community The aim of this work was to present our clinical experience with endoscopic posterior nasal neurectomy in persistent allergic rhinitis
Surgical technique This procedure had been completed under general anesthesia A 00 or a 300 nasal endoscope with a diameter of 4 mm is used throughout the surgery About 1 mL of 1100000 epinephrine was injected at the posterior end of the middle meatus Opening of the maxillary sinus and identification of its ostium to take it as a guide to reach the sphenopalatin foramen Then in the middle meatus a curved incision 15cm long had been made starting from the superior margin of the inferior nasal turbinate up to the horizontal part of the ground lamella of the middle turbinate The dissected mucosal flap had been separated from the vertical plate of the palatine bone and the flap had been folded backwards until exposure of the sphenopalatine notch and the superior margin of the vertical plate of the palatine bone Then at the level of sphenopalatine foramen the neurovascular bundle had been identified with inclusion of the posterior nasal nerve The PNN had identified and sectioned from the sphenopalatine artery only in four cases The rest of cases the whole bundle had been sectioned including the artery there is no significant side effects between both maneuvers To avoid postoperative bleeding a sufficient coagulation had been applied and nasal packing was inserted for 2 days
Surgical technique This procedure had been completed under general anesthesia A 00 or a 300 nasal endoscope with a diameter of 4 mm is used throughout the surgery About 1 mL of 1100000 epinephrine was injected at the posterior end of the middle meatus Opening of the maxillary sinus and identification of its ostium to take it as a guide to reach the sphenopalatin foramen Then in the middle meatus a curved incision 15cm long had been made starting from the superior margin of the inferior nasal turbinate up to the horizontal part of the ground lamella of the middle turbinate The dissected mucosal flap had been separated from the vertical plate of the palatine bone and the flap had been folded backwards until exposure of the sphenopalatine notch and the superior margin of the vertical plate of the palatine bone Then at the level of sphenopalatine foramen the neurovascular bundle had been identified with inclusion of the posterior nasal nerve The PNN had identified and sectioned from the sphenopalatine artery only in four cases The rest of cases the whole bundle had been sectioned including the artery there is no significant side effects between both maneuvers To avoid postoperative bleeding a sufficient coagulation had been applied and nasal packing was inserted for 2 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None