Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

Bilateral Inferior Turbinates Hypertrophy Clinical Trial

Official title:

to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00651092
• Other study ID #: sor466208ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: March 30, 2008
• Last updated: April 1, 2008
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2008
• Source: Soroka University Medical Center
• Contact: nili segal, md
• Phone: +972544268202
• Email: segalna[@]012.net.il
• Is FDA regulated: No
• Health authority: Israel: clalit halth services
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients above 18 years

Exclusion Criteria:

• can not answer a written questionaire

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Inferior Turbinates Hypertrophy
• Hypertrophy

Intervention

Procedure:
• bilateral nasal inferior turbinectomy
the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life		1 year	No
Secondary	rhinomanometry, saccharine test, nasal endoscopy		1 year	No