The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis

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

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.

Study Overview

• Status: Unknown
• Conditions: Sinusitis; Nasal Polyps
• Intervention / Treatment: Diagnostic test: sinonasal outcome test-22

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jianbo Shi, doctor; Phone Number: 8602087333733; Email: shijb@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Fenghong Chen, doctor; Phone Number: 02086013560170816; Email: chfhong@mail.sysu.edu.cn
      • Principal Investigator: jianbo Shi, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic rhinosinusitis patients after endoscopic surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
postoperational CRS; observe the symptoms and endoscopic appearance	Diagnostic test: sinonasal outcome test-22; Evaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients; Other Names: Lund-Kennedy endoscopic score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jianbo Shi
• Investigators: Study Director: Jianbo Shi, doctor, Ent department, the first affiliated hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Surgery; Eosinophil; Diagnosis; Chronic rhinosinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Nasal Polyps
• Other Study ID Numbers: 20171019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No