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
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Inferior Turbinates Hypertrophy focused on measuring turbinectomy
Eligibility Criteria
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
Active Comparator
Arm Label
A1
A2
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
No
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
A1
Arm Type
Active Comparator
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
Arm Title
A2
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
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
Email
segalna@012.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
moshe puterman, md
Phone
+97286400521
Email
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
Learn more about this trial
Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy
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