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Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study

Primary Purpose

Nasal Polyps

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior neurectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasal Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis

Exclusion Criteria:

  • refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Study group

    Control group

    Arm Description

    We will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose

    We will do FESS only in the other side of the nose

    Outcomes

    Primary Outcome Measures

    Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis
    Surgical procedure to evaluate the recurrence of nasal polyposis

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2019
    Last Updated
    December 24, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04105361
    Brief Title
    Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study
    Official Title
    Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis :A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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
    Detailed Description
    Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasal Polyps

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    We will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose
    Arm Title
    Control group
    Arm Type
    Experimental
    Arm Description
    We will do FESS only in the other side of the nose
    Intervention Type
    Procedure
    Intervention Name(s)
    Posterior neurectomy
    Intervention Description
    Cut of posterior nasal nerve
    Primary Outcome Measure Information:
    Title
    Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis
    Description
    Surgical procedure to evaluate the recurrence of nasal polyposis
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis Exclusion Criteria: refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Enas Zarief
    Phone
    01226270800
    Email
    Enaa.tharwat23@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Gad
    Phone
    0102 235 0318
    Email
    Mohamedomar18@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1654132
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study

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