Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

NCT ID: NCT00651092

Last Updated: 2008-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-01-31

Brief Summary

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

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.

Conditions

Bilateral Inferior Turbinates Hypertrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

bilateral nasal inferior turbinectomy

Intervention Type: PROCEDURE

the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed

A2

the resection of the inferior turbinates will be performed endonasally with an endoscopical instruments

Group Type: ACTIVE_COMPARATOR

endoscopic submucosal resection of the inferior turbinates

Intervention Type: PROCEDURE

surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates

Interventions

bilateral nasal inferior turbinectomy

the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

inferior conchectomy; submucosal conchectomy

Eligibility Criteria

Inclusion Criteria

• all patients above 18 years

Exclusion Criteria

• can not answer a written questionaire

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

soroke university medical center

Principal Investigators

nili segal, md

Role: PRINCIPAL_INVESTIGATOR

soroka university medical center beer sheva israel

Central Contacts

nili segal, md

Role: CONTACT

segalna@012.net.il

+972544268202

moshe puterman, md

Role: CONTACT

puterman@netvision.net.il

+97286400521

References

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. doi: 10.1177/000348940010901109.

Reference Type: RESULT

PMID: 11089995 (View on PubMed)

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. doi: 10.1017/s0022215100114707.

Reference Type: RESULT

PMID: 1999659 (View on PubMed)

Other Identifiers

sor466208ctil

Identifier Type: -

Identifier Source: org_study_id