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Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

Primary Purpose

Bilateral Inferior Turbinates Hypertrophy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

bilateral nasal inferior turbinectomy

endoscopic submucosal resection of the inferior turbinates

About this trial

This is an interventional treatment trial for Bilateral Inferior Turbinates Hypertrophy focused on measuring turbinectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

all patients above 18 years

Exclusion Criteria:

can not answer a written questionaire

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

quality of life

Secondary Outcome Measures

rhinomanometry, saccharine test, nasal endoscopy

Full Information

NCT ID

NCT00651092

First Posted

March 30, 2008

Last Updated

April 1, 2008

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00651092

Brief Title

Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

Official Title

to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

May 2008 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bilateral Inferior Turbinates Hypertrophy

Keywords

turbinectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

bilateral nasal inferior turbinectomy

Other Intervention Name(s)

inferior conchectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

endoscopic submucosal resection of the inferior turbinates

Other Intervention Name(s)

submucosal conchectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

quality of life

Time Frame

1 year

Secondary Outcome Measure Information:

Title

rhinomanometry, saccharine test, nasal endoscopy

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all patients above 18 years Exclusion Criteria: can not answer a written questionaire

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

nili segal, md

Phone

+972544268202

segalna@012.net.il

First Name & Middle Initial & Last Name or Official Title & Degree

moshe puterman, md

Phone

+97286400521

puterman@netvision.net.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nili segal, md

Organizational Affiliation

soroka university medical center beer sheva israel

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

11089995

Citation

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.

Results Reference

result

PubMed Identifier

1999659

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. doi: 10.1017/s0022215100114707.

Results Reference

result

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Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

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