Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy - Full Text View

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00651092

Purpose

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

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

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

rhinomanometry, saccharine test, nasal endoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator 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
A2: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

all patients above 18 years

Exclusion Criteria:

can not answer a written questionaire

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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 of 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.

Responsible Party:	soroke university medical center ( Dr nili segal )
Study ID Numbers:	sor466208ctil
Study First Received:	March 30, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00651092
Health Authority:	Israel: clalit halth services

Keywords provided by Soroka University Medical Center:

turbinectomy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy

ClinicalTrials.gov processed this record on January 16, 2009