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Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

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ClinicalTrials.gov Identifier: NCT00651092
Recruitment Status : Unknown
Verified March 2008 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2008
Last Update Posted : April 2, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Bilateral Inferior Turbinates Hypertrophy Procedure: bilateral nasal inferior turbinectomy Procedure: endoscopic submucosal resection of the inferior turbinates

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy
Study Start Date : March 2008
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Procedure: bilateral nasal inferior turbinectomy
the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
Other Name: inferior conchectomy
Active Comparator: A2
the resection of the inferior turbinates will be performed endonasally with an endoscopical instruments
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
Other Name: submucosal conchectomy


Outcome Measures

Primary Outcome Measures :
  1. quality of life [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. rhinomanometry, saccharine test, nasal endoscopy [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients above 18 years

Exclusion Criteria:

  • can not answer a written questionaire
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651092


Contacts
Contact: nili segal, md +972544268202 segalna@012.net.il
Contact: moshe puterman, md +97286400521 puterman@netvision.net.il

Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: nili segal, md soroka university medical center beer sheva israel
More Information

Publications:
Responsible Party: Dr nili segal, soroke university medical center
ClinicalTrials.gov Identifier: NCT00651092     History of Changes
Other Study ID Numbers: sor466208ctil
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008

Keywords provided by Soroka University Medical Center:
turbinectomy

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical