Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT05880134
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '22-item Sino-Nasal Outcome Test (SNOT-22)', 'timeFrame': '6months after surgery', 'description': 'each symptom is 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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allergic rhinitis', 'neurectomy', 'cartilage'], 'conditions': ['Neurectomy']}, 'referencesModule': {'references': [{'pmid': '20816182', 'type': 'BACKGROUND', 'citation': 'Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.'}, {'pmid': '22341334', 'type': 'BACKGROUND', 'citation': 'Kobayashi T, Hyodo M, Nakamura K, Komobuchi H, Honda N. Resection of peripheral branches of the posterior nasal nerve compared to conventional posterior neurectomy in severe allergic rhinitis. Auris Nasus Larynx. 2012 Dec;39(6):593-6. doi: 10.1016/j.anl.2011.11.006. Epub 2012 Feb 15.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAllergic 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.\n\nNerve irritation causes sneezing and itching, the loss of mucosal integrity causes rhinorrhea, and the vascular engorgement leads to nasal blockage.\n\nBased on the nasal symptoms the prevalence of allergic rhinitis in the Indian population is 20-30%.\n\nAllergic rhinitis significantly affects the quality of life, it contributes to missed or unproductive time at school or work, disturbed sleep pattern and daytime somnolence.\n\nThe 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.\n\nRhinorrhea is a frequent symptom reported amongst patients with allergic and vasomotor rhinitis. Most of these patients usually respond well to medical treatment.\n\nIndications for surgical treatment are warranted only when medical treatment fails, or a patient wants a permanent solution.\n\nIn 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).\n\nThe 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.\n\nOther 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.', 'detailedDescription': "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 (e.g., impaired sleep with consequent daytime fatigue which affect overall patient's 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 \\[e.g., 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.\n\nSurgical 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 1:100,000 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, 1.5cm 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with allergic rhinitis\n* Patients fit for surgery.\n\nExclusion Criteria:\n\n* Coagulopathy, systemic diseases, and patients unfit for general anesthesia.'}, 'identificationModule': {'nctId': 'NCT05880134', 'briefTitle': 'Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Cartilage Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries; Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'MKSU 51-2-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional posterior nerve neurectomy', 'description': 'A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .\n\nThe mucoperiosteum is raised gently using a Cottle elevator or a suction freer elevator, after making the initial incision. Care must be taken not to injure the sphenopalatine vessel during flap elevation.\n\nThe peripheral part of the posterior nasal nerve can usually be identified just behind the incision, about 4-5 mm inferior to the sphenopalatine artery or crista ethmoidalis.\n\nI After identifying the nerve fibres, it is cauterised using monopolar suction cautery and cut using microscissors. It is essential to carry out this procedure on both sides for effective results.', 'interventionNames': ['Procedure: conventional posterior nerve neurectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cartilage reinforcement after posterior nerve neurectomy', 'description': 'A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .\n\nThe mucoperiosteum is raised gently using a Cottle elevator or a suction freer elevator, after making the initial incision. Care must be taken not to injure the sphenopalatine vessel during flap elevation.\n\nThe peripheral part of the posterior nasal nerve can usually be identified just behind the incision, about 4-5 mm inferior to the sphenopalatine artery or crista ethmoidalis.\n\nI After identifying the nerve fibres, it is cauterised using monopolar suction cautery and cut using microscissors. It is essential to carry out this procedure on both sides for effective results.', 'interventionNames': ['Procedure: cartilage graft reinforcement after posterior nerve neurectomy']}], 'interventions': [{'name': 'conventional posterior nerve neurectomy', 'type': 'PROCEDURE', 'description': 'A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .\n\nThe mucoperiosteum is raised gently using a Cottle elevator or a suction freer elevator, after making the initial incision. Care must be taken not to injure the sphenopalatine vessel during flap elevation.\n\nThe peripheral part of the posterior nasal nerve can usually be identified just behind the incision, about 4-5 mm inferior to the sphenopalatine artery or crista ethmoidalis.\n\nI After identifying the nerve fibres, it is cauterised using monopolar suction cautery and cut using microscissors. It is essential to carry out this procedure on both sides for effective results.', 'armGroupLabels': ['conventional posterior nerve neurectomy']}, {'name': 'cartilage graft reinforcement after posterior nerve neurectomy', 'type': 'PROCEDURE', 'description': 'A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .\n\nThe mucoperiosteum is raised gently using a Cottle elevator or a suction freer elevator, after making the initial incision. Care must be taken not to injure the sphenopalatine vessel during flap elevation.\n\nThe peripheral part of the posterior nasal nerve can usually be identified just behind the incision, about 4-5 mm inferior to the sphenopalatine artery or crista ethmoidalis.\n\nI After identifying the nerve fibres, it is cauterised using monopolar suction cautery and cut using microscissors. It is essential to carry out this procedure on both sides for effective results.\n\nthen harvest cartilage from nasal septum and refashion it around sphenopalatine bundle to prevent nerve re-innervation\n\nThe mucoperiosteal flaps are repositioned . No nasal packing is required. Patients are discharged on the same day', 'armGroupLabels': ['cartilage reinforcement after posterior nerve neurectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05555', 'city': 'Kafr ash Shaykh', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Kafrelsheikh university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'overallOfficials': [{'name': 'Mohammad Aouf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'kafrelsheikh U'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Mohammad Mahmoud Aouf', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}