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Status unknownNCT03374124Updated Dec 15, 2017

The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis

An observational study in Sinusitis and Nasal Polyps, sponsored by Jianbo Shi. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-15.

Sponsored by Jianbo Shi · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sinusitis
  • Nasal Polyps

Keywords

  • Chronic rhinosinusitis
  • Eosinophil
  • Surgery
  • Diagnosis
03

In context

Sinusitis

256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.

This study's planned enrollment of 100 is below the median of 125 across 44 observational studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

This is the only study on the registry with Jianbo Shi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chronic rhinosinusitis patients after endoscopic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • postoperational CRS

    observe the symptoms and endoscopic appearance

    Diagnostic Test: sinonasal outcome test-22

Interventions

  • Diagnostic testsinonasal outcome test-22

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

    Also known as: Lund-Kennedy endoscopic score

06

What researchers measure

Primary outcomes

  1. nasal symptoms

    presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points).

    Time frame: through study completion, an average of 2 year

  2. 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.)

    Time frame: through study completion, an average of 2 year

07

Study locations

1 of 1 sites recruiting
  • the first affiliated hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    Recruiting
    • Fenghong Chen, doctor · Contactchfhong@mail.sysu.edu.cn · 02086013560170816
    • jianbo Shi, doctor · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2016 (actual). Primary completion is estimated for Jan 2018, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Dec 15, 2017
StartActual
Jan 2016
Primary completionEst.
Jan 2018
CompletionEst.
Jun 2018
Last update
Dec 15, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03374124
Lead sponsor
Jianbo Shi
Responsible party
Jianbo Shi (Professor, First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Dec 15, 2017
Start date
Jan 2016
Primary completion
Jan 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Dec 15, 2017

Study contacts

Jianbo Shi, doctor
Contact
shijb@mail.sysu.edu.cn
8602087333733
Jianbo Shi, doctor
study director · Ent department, the first affiliated hospital, Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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