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Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome

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ClinicalTrials.gov Identifier: NCT01350466
Recruitment Status : Unknown
Verified May 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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. 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.


Condition or disease
Rhinosinusitis

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome
Study Start Date : August 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
FESS patients
Controls


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
chronic rhinosinutis patients undergoing functional endoscopic sinus surgery
Criteria

Inclusion Criteria:

  1. Patients scheduled for sinus surgery because of recurrent acute sinusitis or chronic sinusitis with or without nasal polyps.
  2. Age > 18 and < 65 years
  3. Signed informed consent
  4. Willingness and capability to fill in questionnaire.

Exclusion Criteria:

  1. Patient with diagnosed cystic fibrosis or primary ciliary dysfunction syndrome
  2. Patients that undergo FESS for antrochoanal polyp
  3. Patient that undergo FESS for a malignant process
  4. Patient that are diagnosed with sarcoidosis or any type of vasculitis
More Information

Responsible Party: Valerie Hox, UZLeuven
ClinicalTrials.gov Identifier: NCT01350466     History of Changes
Other Study ID Numbers: S53127
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2011

Keywords provided by Universitaire Ziekenhuizen Leuven:
Chronic rhinosinusitis