The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis

• Conditions: Sinusitis; Nasal Polyps
• Interventions: Diagnostic Test: sinonasal outcome test-22

• Registration Number: NCT03374124
• Lead Sponsor: Jianbo Shi

Brief Summary

Previous studies have demonstrated that the eosinophilic inflammation of nasal mucosa is associated with the uncontrolled condition of chronic rhinosinusitis after surgery. However, the definition of the eosinophilic chronic rhinosinusitis is not very clear. Japanese researchers have designed a scoring system to diagnose eosinophilic chronic rhinosinusitis. In this study, the investigators hope to examine the practicability of this scoring system and have a better knowledge of eosinophilic chronic rhinosinusitis in china.The retrospective study was conducted in a tertiary hospital. Participants received functional endoscopic sinus surgery more than 1 years were called back for evaluation. A diagnosis cut off value of eosinophil count was determined by the surgery prognosis. Then different factors were compared between participants with eosinophilic CRS and those with non-eosinophilic CRS to establish the appropriated diagnosis approach for eosinophilic CRS.

Detailed Description

The retrospective study was conducted in a tertiary hospital. Participants received functional endoscopic sinus surgery more than 1 years were called back for evaluation. A diagnosis cut off value of eosinophil count was determined by the surgery prognosis. Then different factors were compared between participants with eosinophilic CRS and those with non-eosinophilic CRS to establish the appropriated diagnosis approach for eosinophilic CRS.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-11-27
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-15
• Last Update Posted: 2017-12-15
• Primary Completion: 2018-01
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007.

Exclusion Criteria

• Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients.
• Pregnancy or lactation.
• Acute respiratory tract infection within one month before the study.
• Patients without pathological samples.
• Antrochoanal polyp and cyst of the paranasal sinuses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
postoperational CRS	sinonasal outcome test-22	observe the symptoms and endoscopic appearance

Primary Outcome Measures

Name	Time	Method
nasal symptoms	through study completion, an average of 2 year	presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points).
endoscopic appearance indicate the uncontrol of CRS	through study completion, an average of 2 year	The presence of diseased mucosa (nasal polyps, mucopurulent secretions,and/or inflamed mucosa) under endoscopy.; (Lund-kennedy endoscopic score: Polyp≥1 or Oedema≥2 or Discharge≥2; 0-Absence of polyps;1-polyps in middle meatus only;2-polyps beyond middle meatus but not blocking the nose completely;3-polyps completely obstructing the nose.; Oedema: 0-absent; 1-mild; 2-severe.Discharge: 0-no discharge; 1-clear, thin discharge; 2-thick, purulent discharge.)

Trial Locations

Locations (1)

the first affiliated hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China