Olfactory Cleft Stenosis and Obstruction on Paranasal Sinus CT Scan in Pre Septo Rhinoplasty Patients Without Respiratory Mucosa Pathology : Normal Variants or Pathologic Findings ?

October 8, 2023 updated by: JANKOWSKI Roger, Central Hospital, Nancy, France
This retrospective studed included patients referred to our institution between December 2013 and december 2021 for septoplasty or septorhinoplasty. All patients underwent pre operatory paranasal sinus CT scan and olfactory test. Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).

Study Overview

Status

Recruiting

Conditions

Detailed Description

In this retrospective study, We will include every patients over 18 years old who had a septoplasty or septorhinoplasty between December 2013 and December 2021 and who underwent paranasal CT scan and olfactory test (sniffin stick test).

The patients will be find thanks to social security code GAMA007 for septoplastie, GAMA 004, 010 for septorhinoplasty and olfactometry GJQP001.

The patients with mucosa pathology on CT scan or with record of chronic respiratory rhinitis, septum perforation or a pathology that can alter the olfaction on the consultation report will be excluded.

Olfactory measurements were performed before surgery using the threshold and identification subtests of Sniffin Stick Test. Olfactory status will be classified by taking into account the normative data provided by Hummel et al and the real identification score. The patients will be classified as normosmic if the threshold and the identification score is superior the tenth percentile. If not, they will be classified as anosmic if both score are 0 and hyposmic otherwise.

2 experienced radiologists will perform the measures on paranasal sinus CT. They will be blinded to olfactory results.

The olfactory cleft boundaries were determined in the coronal plane : Anterior boundary was defined by the anterior attachment of the middle turbinate; the posterior boundary corresponding to the anterior face of the sphenoid sinus; the lateral boundaries were defined as the attachment of the middle and/or superior turbinate laterally and the nasal septum medially. Olfactory clefts were divided into an anterior and a posterior compartment, defined as "middle olfactory recess" and "superior olfactory recess", laterally bounded by the middle and the superior turbinate lamella, respectively.

Each olfactory recess width, global olfactory Cleft width and cribriform plate width will be measured in the coronal plane, at the level of the cribriform plate and 5mm underneath at 5 different sites :

  1. - First slice depicting the cribriform plate (entry of the middle olfactory recess)
  2. - Middle of the middle olfactory recess (halfway throuh 1 and 3)
  3. - First slice depicting the head of the superior turbinate (entry of the superior olfactory recess)
  4. - Middle of the superior olfactory recess (halfway through 3 and 5)
  5. - Anterior face of sphenoid sinus Olfactory cleft length will be determined in the sagittal plane as length of the cribriform plate.

Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), A global olfactory cleft status will be obtained : no significant or partial stenosis in any compartment, total stenosis in case of complete stenosis in every compartment and intermediate stenosis in any other situation.

Olfactory Cleft obstruction will be classified as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).

Olfactory cleft lateral boundaries will be evaluated for the presence of a lamellar pneumatization (superior, middle or lamellar concha bullosa).

Olfactory groove depth was classified according to the Keros classification in regard of the middle and superior olfactory recess.

as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
      • Nancy, France
        • Recruiting
        • Centre Hospitalier Régional Universitaire - Service ORL
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

- Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty without respiratory mucosa pathology Sex, mean age Olfactory test threshold and identification using sniffin stick test. Classification normosmic or hyposmic using Hummel table.

Description

Inclusion Criteria:

  • Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty

Exclusion Criteria:

  • Respiratory mucosa pathology on CT (polyposis, opacification of the maxillary sinuses, ethmoid cells, frontal sinus, sphenoidal sinus, sinonasal tumor)
  • septal perforation
  • chronic respiratory rhinitis (allergic, vasomotor, mucoviscidosis)
  • pathologie that can alter olfaction (multiple sclerosis, meningioma, post infection such as COVID)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Olfactory cleft stenosis or obstruction
Time Frame: 1 day
Measures will classify as none, partial or total stenosis or obstruction
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of olfactory cleft stenosis or obstruction
Time Frame: 1 day
Are patients with stenosis or obstruction hypsomic or anosmic
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

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.

General Publications

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 (Actual)

August 1, 2023

Primary Completion (Estimated)

October 8, 2023

Study Completion (Estimated)

October 25, 2023

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PI023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The initial database of patients with olfactory measure and septoplasty or septorhinoplasty can be used for other research as well the one with the patients included (without mucosa pathology)

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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