Nasal PolypsNCT04105361
Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study
A study testing Posterior neurectomy in people with Nasal Polyps, run by Assiut University.
Trial summary
The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Posterior neurectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis
Who cannot join
- refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis :A Comparative Study
The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis
Read the detailed description
Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate
- Conditions
- Nasal Polyps
- Being tested
- Posterior neurectomy
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior neurectomyProcedure or surgery
Cut of posterior nasal nerve
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | We will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose Receives: Procedure: Posterior neurectomy |
| Control group | Experimental | We will do FESS only in the other side of the nose Receives: Procedure: Posterior neurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis
Surgical procedure to evaluate the recurrence of nasal polyposis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startJan 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ET Zarief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105361
- Sponsor's protocol ID
- Nasal polyposis
- Status last verified
- Dec 2019
- First submitted
- 25 Sep 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mengeling WL. Anamnestic immune response of pigs to pseudorabies virus: latent virus reactivation versus direct oronasal and parenteral exposure to virus. J Vet Diagn Invest. 1991 Apr;3(2):133-6. doi: 10.1177/104063879100300205.
PubMed 1654132
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis :A Comparative Study
- ClinicalTrials.gov ID
- NCT04105361
- Acronym / sponsor ID
- Nasal polyposis
- Conditions
- Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 26 Sep 2019 (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.
The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis
Detailed description
Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Posterior neurectomyWe will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose |
| Control group | Experimental | Procedure: Posterior neurectomyWe will do FESS only in the other side of the nose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis
Key exclusion criteria (1 listed)
- refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome
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 |
|---|---|---|
| Posterior neurectomyCut of posterior nasal nerve | Procedure or surgery | Control group, Study group |
Primary outcome
Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis
Time frame: 1 year
Surgical procedure to evaluate the recurrence of nasal polyposis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Background: PubMed 1654132Mengeling WL. Anamnestic immune response of pigs to pseudorabies virus: latent virus reactivation versus direct oronasal and parenteral exposure to virus. J Vet Diagn Invest. 1991 Apr;3(2):133-6. doi: 10.1177/104063879100300205.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior neurectomy in people with Nasal Polyps, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enas Zarief (01226270800, Enaa.tharwat23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis (time frame: 1 year). 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 NCT04105361, which also lists 1 linked publication.
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 27 Dec 2019.