The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis

Sinusitis Clinical Trial

Official title:

The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis: A Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03374124
• Other study ID #: 20171019
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2017
• Last updated: December 11, 2017
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: December 2017
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Jianbo Shi, doctor
• Phone: 8602087333733
• Email: shijb[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Polyps
• Sinusitis

Intervention

Diagnostic Test:
• sinonasal outcome test-22
Evaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients

Locations

Country	Name	City	State
China	the first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jianbo Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nasal symptoms	presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points).	through study completion, an average of 2 year
Primary	endoscopic appearance indicate the uncontrol of CRS	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.)	through study completion, an average of 2 year