Trial record 2 of 4 for:    Open Studies | "Occupational Exposure"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
AMC Amsterdam
University Hospital, Ghent
Algemeen Ziekenhuis Sint-Lucas Gent
Hopital Sint-Luc Bruxelles
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01350466
First received: May 6, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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
Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
FESS patients
Controls

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Valerie Hox, UZLeuven
ClinicalTrials.gov Identifier: NCT01350466     History of Changes
Other Study ID Numbers: S53127
Study First Received: May 6, 2011
Last Updated: May 6, 2011
Health Authority: Belgium: UZLeuven

Keywords provided by Universitaire Ziekenhuizen Leuven:
Chronic rhinosinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014