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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01350466
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), University Hospital, Ghent (Other), AZ Sint-Lucas Gent (Other), Hopital Sint-Luc Bruxelles (Other)
200
25

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Aug 1, 2011
    Anticipated Primary Completion Date :
    Mar 1, 2013
    Anticipated Study Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    FESS patients

    Controls

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 65 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Universitaire Ziekenhuizen Leuven
      • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
      • University Hospital, Ghent
      • AZ Sint-Lucas Gent
      • Hopital Sint-Luc Bruxelles

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01350466
      Other Study ID Numbers:
      • S53127
      First Posted:
      May 9, 2011
      Last Update Posted:
      May 9, 2011
      Last Verified:
      May 1, 2011
      Keywords provided by , ,

      Study Results

      No Results Posted as of May 9, 2011