RhinosinusitisNCT01350466
Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome
An observational study of Rhinosinusitis, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune, infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus surgery (FESS) is the therapy of choice. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Sep 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: chronic rhinosinutis patients undergoing functional endoscopic sinus surgery
Who may be able to join
- Patients scheduled for sinus surgery because of recurrent acute sinusitis or chronic sinusitis with or without nasal polyps.
- Age > 18 and < 65 years
- Signed informed consent
- Willingness and capability to fill in questionnaire.
Who cannot join
- Patient with diagnosed cystic fibrosis or primary ciliary dysfunction syndrome
- Patients that undergo FESS for antrochoanal polyp
- Patient that undergo FESS for a malignant process
- Patient that are diagnosed with sarcoidosis or any type of vasculitis
About this study
The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune, infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients that undergo FESS, need revision surgery within the 3 years following initial surgery. Causes of failure are multiple and not fully understood.
As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced by occupational factors as well. No data are currently available on how these factors may contribute to the disease manifestation, whereas negligence of these factors as potential causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal condition and even give rise to the induction of bronchial symptoms. There exists no documentation on the role of the occupational agents on chronic sinus disease.
This prospective study aims at providing data about the exposure levels of patients that undergo sinus surgery and correlate them with both subjective and objective postoperative parameters. This will be done by providing a questionnaire that was developed at our department to all patients that are planned for sinus surgery at the participating centers. This questionnaire asks for medical history, current sinonasal symptoms, professional history and recreational occupation. An extensive list of occupational agents is given and patients are asked to indicate those that they encounter at work or during recreational activities. This will be followed by an extensive clinical investigation including nasal endoscopy. These investigations (questionnaire and clinical examination) will be repeated at 3 months and 12 months after surgery.
- Conditions
- Rhinosinusitis
- Keywords
- Chronic rhinosinusitis
- 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 |
|---|---|---|
| FESS patients | Not described | |
| Controls | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2017
- Study completionSep 2017
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital, Ghent, AZ Sint-Lucas Gent, Hopital Sint-Luc Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350466
- Sponsor's protocol ID
- S53127
- Status last verified
- Jun 2024
- First submitted
- 6 May 2011
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome
- ClinicalTrials.gov ID
- NCT01350466
- Acronym / sponsor ID
- S53127
- Conditions
- Rhinosinusitis
- Keywords
- Chronic rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital, Ghent, AZ Sint-Lucas Gent, Hopital Sint-Luc Bruxelles
- Study start
- Aug 2011 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 May 2011 (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.
The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune, infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients that undergo FESS, need revision surgery within the 3 years following initial surgery. Causes of failure are multiple and not fully understood.
As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced by occupational factors as well. No data are currently available on how these factors may contribute to the disease manifestation, whereas negligence of these factors as potential causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal condition and even give rise to the induction of bronchial symptoms. There exists no documentation on the role of the occupational agents on chronic sinus disease.
This prospective study aims at providing data about the exposure levels of patients that undergo sinus surgery and correlate them with both subjective and objective postoperative parameters. This will be done by providing a questionnaire that was developed at our department to all patients that are planned for sinus surgery at the participating centers. This questionnaire asks for medical history, current sinonasal symptoms, professional history and recreational occupation. An extensive list of occupational agents is given and patients are asked to indicate those that they encounter at work or during recreational activities. This will be followed by an extensive clinical investigation including nasal endoscopy. These investigations (questionnaire and clinical examination) will be repeated at 3 months and 12 months after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FESS patients | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- chronic rhinosinutis patients undergoing functional endoscopic sinus surgery
Key inclusion criteria (4 listed)
- Patients scheduled for sinus surgery because of recurrent acute sinusitis or chronic sinusitis with or without nasal polyps.
- Age > 18 and < 65 years
- Signed informed consent
- Willingness and capability to fill in questionnaire.
Key exclusion criteria (4 listed)
- Patient with diagnosed cystic fibrosis or primary ciliary dysfunction syndrome
- Patients that undergo FESS for antrochoanal polyp
- Patient that undergo FESS for a malignant process
- Patient that are diagnosed with sarcoidosis or any type of vasculitis
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinosinusitis, run by Universitaire Ziekenhuizen KU Leuven.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 1 Jul 2024.