The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis

NCT03374124 | Unknown

• 1 other identifier: 20171019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis; Nasal Polyps

Keywords

Chronic rhinosinusitis; Eosinophil; Surgery; Diagnosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

postoperational CRS

observe the symptoms and endoscopic appearance

Diagnostic Test: sinonasal outcome test-22

Interventions

sinonasal outcome test-22 DIAGNOSTIC_TEST

Evaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients

Also known as: Lund-Kennedy endoscopic score

postoperational CRS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic rhinosinusitis patients after endoscopic surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jianbo Shi: lead

Study Sites (1)

the first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The samples were abtained during endoscopic sinus surgery

MeSH Terms

Conditions

Sinusitis; Nasal Polyps; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Jianbo Shi, doctor

  Ent department, the first affiliated hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Jianbo Shi, doctor

CONTACT

8602087333733; shijb@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 15, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

CN (1)