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'The Factors Associated With the Formation of Nasal Polyp'


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Open (Enrolling)
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Nasal Polyp, Smoking, Rhinosinusitis, Allergic Rhinitis, Deviated Nasal Septum, ASA Intolerant Asthma

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Trial Information

'The Factors Associated With the Formation of Nasal Polyp'


The present study involves two parts. A case control study wherein the association of nasal
polyps with various risk factors like smoking, wood stove exposure, allergic rhinitis, non
vegetarian diet intake, rhino sinusitis, deviated nasal septum, occupational dust exposure
and eosinophilia.This will be studied individually for antrochoanal and ethmoidal nasal
polyps.Again the same will be studied with respect to the recurrent and non recurrent
polyps.

A descriptive study focuses on the nasal polyp occurrence with respect to the age, sex,
religion, socioeconomic status, urban or rural preponderance,overcrowding, aspirin
intolerance, family history etc.

The results will be studies after calculating the odds ratio and the chi square test for
whatever data is available. Interpretation will be performed subsequently.

Gene expression profiling would be performed to study the differences in gene expression
levels between AC and EP s with respect to risk factors and morphological
characteristics.Mutational analysis will be performed to identify mutations in selected
genes.


Inclusion Criteria:



1. Antrochoanal and ethmoidal nasal polyps

2. Recurrent nasal polyps

3. Both infected and non infected polyps

4. Both eosinophilic and non eosinophilic polyps

Exclusion Criteria:

1. Exclusive neoplasms of nose and para nasal sinuses

2. Immunodeficiency status like HIV

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Association of the antrochoanal and ethmoidal polyps with smoking, wood stove exposure, allergic rhinitis, deviated nasal septum, rhino sinusitis, non vegetarian diet,eosinophilia and staphylococcus aureus in terms of the odds ratio.

Outcome Description:

Based on the questionnaire the patient will be evaluated for the presence of risk factors. Patient will be subjected to appropriate investigations like complete hemogram, absolute eosinophil count, contrast tomography scan of the paransal sinuses and serum IgE levels will be performed.An odds ratio will be calculated after taking appropriate controls in the ratio of 2:1.Significance levels will be calculated using Chi square test.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Dr.Manjunath D Narasaiah, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistant Professor in ENT, Karnataka Institute of Medical Sciences, Hubli-580021, Karnataka, India

Authority:

India: Institutional research regulatory committee

Study ID:

KIMSPGS412

NCT ID:

NCT01278719

Start Date:

January 2010

Completion Date:

June 2013

Related Keywords:

  • Nasal Polyp
  • Smoking
  • Rhinosinusitis
  • Allergic Rhinitis
  • Deviated Nasal Septum
  • ASA Intolerant Asthma
  • Antrochoanal polyp
  • Ethmoidal polyp
  • Recurrence
  • Risk factors
  • Environmental factors
  • Gene expression
  • Micro array
  • Mutation
  • Nasal Polyps
  • Polyps
  • Rhinitis
  • Smoking
  • Nose Deformities, Acquired
  • Sinusitis

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