NCT04105361

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

September 25, 2019

Last Update Submit

December 24, 2019

Conditions

Nasal Polyps

Outcome Measures

Primary Outcomes (1)

  • Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis

    Surgical procedure to evaluate the recurrence of nasal polyposis

    1 year

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: Posterior neurectomy

Control group

EXPERIMENTAL

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

Procedure: Posterior neurectomy

Interventions

Posterior neurectomyPROCEDURE

Cut of posterior nasal nerve

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 1654132BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Enas Zarief

CONTACT

01226270800Enaa.tharwat23@gmail.com

Mohamed Gad

CONTACT

0102 235 0318Mohamedomar18@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

January 1, 2020

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

December 27, 2019

Record last verified: 2019-12