Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

Brief Summary

Official Title: “to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy”

The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: May 2008

Detailed Clinical Trial Description

The two methods of nasal inferior turbinectomy are well popularized and in use for long periods of time. Endoscopic submucosal inferior turbinectomy is performed in our hospital and blunt turbinectomy is performed usually in privat clinics outside the hospital where there is no endoscopic equipment. We will examine both subjective (QOL questionaire) and objective parameters(rhinomanometry- a non invasive method to evaluate nasal airflow, saccharine test, nasal endoscopy) in our comparison of the outcome of these two methods.

Interventions Used in this Clinical Trial

  • Procedure: bilateral nasal inferior turbinectomy
    • the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
  • Procedure: endoscopic submucosal resection of the inferior turbinates
    • surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: A1
    • since the two methods of turbinectomy are in used on a regular basis there is no way to perform double blind study- both the surgeon and the patients are well aware of the operation they are about to go. we just compare several parameters in patients who are anyway about to undergo an operation in a specific method that is used by their surgeon
  • Active Comparator: A2
    • the resection of the inferior turbinates will be performed endonasally with an endoscopical instruments

Outcome Measures for this Clinical Trial

Primary Measures

  • quality of life
    • Time Frame: 1 year
      Safety Issue?: No

Secondary Measures

  • rhinomanometry, saccharine test, nasal endoscopy
    • Time Frame: 1 year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • all patients above 18 years

Exclusion Criteria

  • can not answer a written questionaire

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Soroka University Medical Center
  • Provider of Information About this Clinical Study
    • Dr nili segal, soroke university medical center
  • Overall Official(s)
    • nili segal, md, Principal Investigator, soroka university medical center beer sheva israel
  • Overall Contact(s)
    • nili segal, md, +972544268202, segalna@012.net.il

Citations Reporting on Results

Fradis M, Golz A, Danino J, Gershinski M, Goldsher M, Gaitini L, Malatskey S, Armush W. Inferior turbinectomy versus submucosal diathermy for inferior turbinate hypertrophy. Ann Otol Rhinol Laryngol. 2000 Nov;109(11):1040-5.

Williams HO, Fisher EW, Golding-Wood DG. 'Two-stage turbinectomy': sequestration of the inferior turbinate following submucosal diathermy. J Laryngol Otol. 1991 Jan;105(1):14-6.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00651092