RhinosinusitisNCT01296919
The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis
An observational study of Rhinosinusitis, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Dec 2011
- Phase
- Observational
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 chronic rhinosinusitis whose uncinate process had to be removed to enable surgical access to the sinuses.
Who may be able to join
- Patients with chronic rhinosinusitis who:
- Failed conservative medical treatment.
- Stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
- Had a Lund-MacKay CT score of 2 and higher of 24 available.
Who cannot join
- Immunosuppressed patients.
- Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
- Patients with a Lund-MacKay CT score < 2 of 24 available.
- Pregnant women.
- Patients who underwent prior endoscopic sinus surgery.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
AssutaHS
Tel Aviv
Eitan Yaniv, MD, 052-2509890, docyaniv@yahoo.com
Roee Landsberg, MD, 052-4266359
About this study
Official title: New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis
Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.
Read the detailed description
The purpose of the present study is to gain insight into the histopathological changes of the uncinate process in patients with chronic rhinosinusitis through comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).
- Conditions
- Rhinosinusitis
- Keywords
- Chronic rhinosinusitis, Histopathology, Infundibulum, Lamina propria, Uncinate process
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sinus drainage | Adult patients with chronic rhinosinusitis who failed treatment with antibiotics and topical corticosteroids and underwent endoscopic sinus surgery. Preoperative evaluation included paranasal sinus CT scans. The diagnosis was confirmed by endoscopic examination showing purulent and/or mucopurulent discharge in the middle and/or superior meatus. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilead Berger, MD, Principal investigator, AssutaHS, Meir Medical CenterEitan Yaniv, MD, Study chair, Assuta Hospital SystemsRoee Landsberg, MD, Study director, Assuta Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296919
- Sponsor's protocol ID
- AssutaHS10-2010037
- Status last verified
- Feb 2011
- First submitted
- 14 Feb 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes