Impact of Structural and Microenvironmental Abnormalities in Olfactory Cleft on Olfaction in CRS

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

The purpose of this research is to investigate the impact of structural abnormalities and microenvironmental changes in the olfactory cleft on olfactory function in patients with chronic rhinosinusitis (CRS). It sought to elucidate the complex relationships among structural abnormalities, microenvironmental changes, and inflammatory factors contributing to olfactory dysfunction through a multidimensional assessment encompassing imaging, aerodynamics, biomarker , and histopathology analysis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed with CRS based on the diagnostic criteria of the EPOS guideline.

Provision of signed and dated informed consent form.

Patients with CRS admitted to the hospital awaiting endoscopic sinus surgery.

Healthy controls undergoing surgery for the deviated septum.

Disqualifiers

Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks.

Patients who have had prior sinus surgery.

Patients with fungal sinusitis, inverted papilloma, or other nasal diseases.

Patients with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses.

Trial population

Surgical patients were recruited from the Department of Otolaryngology at Peking University Third Hospital in clinic.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Computed Tomography

    Other intervention

    low-dose CT is taken

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Patients with CRS admitted for endoscopic sinus surgery1 intervention
Group B: healthy controls undergoing surgery for the deviated septum1 intervention

Trial outcomes

Primary outcomes

1

Sniffin Sticks Test

The test consists of odorous rods that are presented to the patient's nose. It consists of 3 parts different, with 3 sets of corresponding sticks: an olfactory threshold test, an olfactory discrimination test and an olfactory identification test. The final TDI score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores.

Time frame
Immediately before surgery

Secondary outcomes

1

The 22-item Sino-Nasal Outcome Test (SNOT-22)

Time frame
Immediately before surgery
2

Visual analog scale(VAS)for olfaction

numerical rating scale from 0 (no smell) to 10 (perfect smell)

Time frame
Immediately before surgery
3

The Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)

The QOD-NS comprises 17 negatively phrased statements, each rated on a scale from 0 (disagree) to 3 (agree), yielding a maximum score of 51. Higher QOD-NS scores indicate a poorer quality of life.

Time frame
Immediately before surgery
4

The original version of olfactory cleft CT score

Time frame
during routine preoperative CT imaging

Other outcomes

Sponsors and contacts

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