An observational study in Olfactory Impairment, sponsored by Central Hospital, Nancy, France. Recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Central Hospital, Nancy, France · Observational
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).
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 :
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).
70 studies on the registry are indexed under Olfaction Disorders; 18 are open to participants now.
This study's planned enrollment of 75 is close to the median of 81 across 16 observational studies indexed under Olfaction Disorders.
Browse Olfaction Disorders studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Exclusion Criteria:
Olfactory cleft stenosis or obstruction
Measures will classify as none, partial or total stenosis or obstruction
Time frame: 1 day
Impact of olfactory cleft stenosis or obstruction
Are patients with stenosis or obstruction hypsomic or anosmic
Time frame: 1 day
Plan to share: Undecided — 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)
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Central Hospital, Nancy, France →