SinusitisNCT03374124
The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis
An observational study of Sinusitis and Nasal Polyps, run by Jianbo Shi at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sinusitis, Nasal Polyps
- What is being tested?
- sinonasal outcome test-22
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic rhinosinusitis patients after endoscopic surgery
Who may be able to join
- Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Fenghong Chen, doctor, 02086013560170816, chfhong@mail.sysu.edu.cn
jianbo Shi, doctor
About this study
Official title: 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.
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.
- Conditions
- Sinusitis, Nasal Polyps
- Being tested
- sinonasal outcome test-22
- Keywords
- Chronic rhinosinusitis, Eosinophil, Surgery, Diagnosis
- Medical subject headings
- Sinusitis, Nasal Polyps, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinonasal outcome test-22Diagnostic test
Also called Lund-Kennedy endoscopic score
Evaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients
| Study group | Role | What they receive |
|---|---|---|
| postoperational CRS | observe the symptoms and endoscopic appearance Receives: Diagnostic Test: sinonasal outcome test-22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal symptoms
presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points).
Measured: 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.)
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianbo Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianbo Shi, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jianbo Shi, doctor, Study director, Ent department, the first affiliated hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374124
- Sponsor's protocol ID
- 20171019
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03374124
- Acronym / sponsor ID
- 20171019
- Conditions
- Sinusitis, Nasal Polyps
- Keywords
- Chronic rhinosinusitis, Eosinophil, Surgery, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jianbo ShiUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperational CRS | – | Diagnostic Test: sinonasal outcome test-22observe the symptoms and endoscopic appearance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic rhinosinusitis patients after endoscopic surgery
Key inclusion criteria (1 listed)
- Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sinonasal outcome test-22Also: Lund-Kennedy endoscopic scoreEvaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients | Diagnostic test | postoperational CRS |
Primary outcome
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).
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.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianbo Shi, doctor study director
Ent department, the first affiliated hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis and Nasal Polyps, run by Jianbo Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianbo Shi, doctor (8602087333733, shijb@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasal symptoms (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.