- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105361
Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study
December 24, 2019 updated by: ET Zarief, Assiut University
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
Study Overview
Detailed Description
Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Study group
We will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose
|
Cut of posterior nasal nerve
|
|
EXPERIMENTAL: Control group
We will do FESS only in the other side of the nose
|
Cut of posterior nasal nerve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 1, 2020
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (ACTUAL)
September 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 27, 2019
Last Update Submitted That Met QC Criteria
December 24, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nasal polyposis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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