NeurectomyNCT05880134
Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries
A study testing conventional posterior nerve neurectomy and cartilage graft reinforcement after posterior nerve neurectomy in people with Neurectomy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurectomy
- What is being tested?
- conventional posterior nerve neurectomy and cartilage graft reinforcement after posterior nerve neurectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with allergic rhinitis
- Patients fit for surgery.
Who cannot join
- Coagulopathy, systemic diseases, and patients unfit for general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cartilage Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries; Randomized Controlled Trial.
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.
Read more
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.
Read the 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 (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.
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 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
- Conditions
- Neurectomy
- Being tested
- conventional posterior nerve neurectomy, cartilage graft reinforcement after posterior nerve neurectomy
- Keywords
- allergic rhinitis, neurectomy, cartilage
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional posterior nerve neurectomyProcedure or surgery
A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .
The 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.
The 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.
I 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.
cartilage graft reinforcement after posterior nerve neurectomyProcedure or surgery
A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .
The 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.
The 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.
I 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.
then harvest cartilage from nasal septum and refashion it around sphenopalatine bundle to prevent nerve re-innervation
The mucoperiosteal flaps are repositioned . No nasal packing is required. Patients are discharged on the same day
| Study group | Role | What they receive |
|---|---|---|
| conventional posterior nerve neurectomy | Active comparator | A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .
The 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.
The 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.
I 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. Receives: Procedure: conventional posterior nerve neurectomy |
| cartilage reinforcement after posterior nerve neurectomy | Active comparator | A vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. .
The 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.
The 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.
I 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. Receives: Procedure: cartilage graft reinforcement after posterior nerve neurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
22-item Sino-Nasal Outcome Test (SNOT-22)
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).
Measured: 6months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start12 Mar 2022
- Primary completion30 May 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeurectomyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Mahmoud Aouf, Kafrelsheikh University
- Investigators
- Mohammad Aouf, Principal investigator, kafrelsheikh U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880134
- Sponsor's protocol ID
- MKSU 51-2-13
- Status last verified
- Sep 2024
- First submitted
- 16 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20816182Kobayashi 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.
PubMed 22341334
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries; Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05880134
- Acronym / sponsor ID
- MKSU 51-2-13
- Conditions
- Neurectomy
- Keywords
- allergic rhinitis, neurectomy, cartilage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional posterior nerve neurectomy | Active comparator | Procedure: conventional posterior nerve neurectomyA vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. . The 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. The 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. I 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. |
| cartilage reinforcement after posterior nerve neurectomy | Active comparator | Procedure: cartilage graft reinforcement after posterior nerve neurectomyA vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. . The 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. The 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. I 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with allergic rhinitis
- Patients fit for surgery.
Key exclusion criteria (1 listed)
- Coagulopathy, systemic diseases, and patients unfit for general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional posterior nerve neurectomyA vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. . The 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. The 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. I 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. | Procedure or surgery | conventional posterior nerve neurectomy |
| cartilage graft reinforcement after posterior nerve neurectomyA vertical incision is made behind the posterior fontanelle. The posterior end of the posterior fontanelle is identified by palpation with an elevator. . The 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. The 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. I 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. then harvest cartilage from nasal septum and refashion it around sphenopalatine bundle to prevent nerve re-innervation The mucoperiosteal flaps are repositioned . No nasal packing is required. Patients are discharged on the same day | Procedure or surgery | cartilage reinforcement after posterior nerve neurectomy |
Primary outcome
22-item Sino-Nasal Outcome Test (SNOT-22)
Time frame: 6months after surgery
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 20816182Brozek 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.
- Background: PubMed 22341334Kobayashi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Aouf principal investigator
kafrelsheikh U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional posterior nerve neurectomy and cartilage graft reinforcement after posterior nerve neurectomy in people with Neurectomy, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
22-item Sino-Nasal Outcome Test (SNOT-22) (time frame: 6months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.