Chronic RhinosinusitisCTNCT00899561
Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis
An observational study of Chronic Rhinosinusitis, run by Meir Medical Center at 2 sites in Israel.
Trial summary
In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- How many people
- 45 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2008to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a limited (of 1-8), intermediate (9-16), and extensive (17-24) sinus disease.
Who may be able to join
- Adult patients with chronic rhinosinusitis who failed conservative medical treatment,
- Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
Who cannot join
- Immunosuppressed patients,
- Patients in whom no indication to excise the middle turbinate was found, AND
- Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
Trial locations and contacts
2 sites in 1 country.
Gilead Berger, MD contact
Israel2 sites, 2 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Gilead Berger, MD
- Recruiting
Meir Medical Center
Kfar Saba
Gilead Berger, MD, berger45@netvision.net.il
About this study
Official title: Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis
In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group.
The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.
- Conditions
- Chronic Rhinosinusitis
- Keywords
- Chronic rhinosinusitis, Computed tomography, Histology, Middle turbinate, Morphometry, osteomyelitis, polyps
- Medical subject headings
- Osteomyelitis, Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation of soft tissue and bony elements of the middle turbinate
Measured: two years
Secondary outcomes (1)
correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies 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
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
- Investigators
- Gilead Berger, MD, Principal investigator, Meir Medical CenterRoee Landsberg, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899561
- Sponsor's protocol ID
- MeirMc
- Acronym
- CT
- Status last verified
- Mar 2012
- First submitted
- 11 May 2009
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT00899561
- Acronym / sponsor ID
- CT / MeirMc
- Conditions
- Chronic Rhinosinusitis
- Keywords
- Chronic rhinosinusitis, Computed tomography, Histology, Middle turbinate, Morphometry, osteomyelitis, polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 12 May 2009 (estimated)
- 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.
In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group.
The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a limited (of 1-8), intermediate (9-16), and extensive (17-24) sinus disease.
Key inclusion criteria (2 listed)
- Adult patients with chronic rhinosinusitis who failed conservative medical treatment,
- Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
Key exclusion criteria (3 listed)
- Immunosuppressed patients,
- Patients in whom no indication to excise the middle turbinate was found, AND
- Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
inflammation of soft tissue and bony elements of the middle turbinate
Time frame: two years
1 secondary outcome
correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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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.
Gilead Berger, MD contact
Gilead Berger, MD principal investigator
Meir Medical Center
Roee Landsberg, MD principal investigator
Tel-Aviv Sourasky Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis, run by Meir Medical Center at 2 sites in Israel.
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 2 inclusion and 3 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 Gilead Berger, MD (berger45@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation of soft tissue and bony elements of the middle turbinate (time frame: two years). 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 19 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.