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The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT03374124
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jianbo Shi, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment
Sinusitis Nasal Polyps 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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis: A Retrospective Study
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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 Name: Lund-Kennedy endoscopic score




Primary Outcome Measures :
  1. nasal symptoms [ Time Frame: through study completion, an average of 2 year ]
    presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points).

  2. endoscopic appearance indicate the uncontrol of CRS [ Time Frame: 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.)



Biospecimen Retention:   Samples With DNA
The samples were abtained during endoscopic sinus surgery


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic rhinosinusitis patients after endoscopic surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374124


Contacts
Contact: Jianbo Shi, doctor 8602087333733 shijb@mail.sysu.edu.cn

Locations
China, Guangdong
the first affiliated hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Fenghong Chen, doctor    02086013560170816    chfhong@mail.sysu.edu.cn   
Principal Investigator: jianbo Shi, doctor         
Sponsors and Collaborators
Jianbo Shi
Investigators
Study Director: Jianbo Shi, doctor Ent department, the first affiliated hospital, Sun Yat-sen University

Responsible Party: Jianbo Shi, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03374124     History of Changes
Other Study ID Numbers: 20171019
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianbo Shi, First Affiliated Hospital, Sun Yat-Sen University:
Chronic rhinosinusitis
Eosinophil
Surgery
Diagnosis

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical