Bilateral Inferior Turbinates HypertrophyNCT00651092
Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy
A study testing bilateral nasal inferior turbinectomy and endoscopic submucosal resection of the inferior turbinates in people with Bilateral Inferior Turbinates Hypertrophy, run by Soroka University Medical Center.
Trial summary
The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Inferior Turbinates Hypertrophy
- What is being tested?
- bilateral nasal inferior turbinectomy and endoscopic submucosal resection of the inferior turbinates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients above 18 years
Who cannot join
- can not answer a written questionaire
Trial locations and contacts
No sites are listed yet.
About this study
Official title: to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy
The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters.
Read the 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.
- Being tested
- bilateral nasal inferior turbinectomy, endoscopic submucosal resection of the inferior turbinates
- Keywords
- turbinectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral nasal inferior turbinectomyProcedure or surgery
Also called inferior conchectomy
the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed
endoscopic submucosal resection of the inferior turbinatesProcedure or surgery
Also called submucosal conchectomy
surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: bilateral nasal inferior turbinectomy |
| A2 | Active comparator | the resection of the inferior turbinates will be performed endonasally with an endoscopical instruments Receives: Procedure: endoscopic submucosal resection of the inferior turbinates |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measured: 1 year
Secondary outcomes (1)
rhinomanometry, saccharine test, nasal endoscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bilateral Inferior Turbinates HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- nili segal, md, Principal investigator, soroka university medical center beer sheva israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651092
- Sponsor's protocol ID
- sor466208ctil
- Status last verified
- Mar 2008
- First submitted
- 30 Mar 2008
- Last updated
- 2 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11089995Williams 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.
PubMed 1999659
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy
- ClinicalTrials.gov ID
- NCT00651092
- Acronym / sponsor ID
- sor466208ctil
- Keywords
- turbinectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2008 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Procedure: bilateral nasal inferior turbinectomysince 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 |
| A2 | Active comparator | Procedure: endoscopic submucosal resection of the inferior turbinatesthe resection of the inferior turbinates will be performed endonasally with an endoscopical instruments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients above 18 years
Key exclusion criteria (1 listed)
- can not answer a written questionaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral nasal inferior turbinectomyAlso: inferior conchectomythe operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed | Procedure or surgery | A1 |
| endoscopic submucosal resection of the inferior turbinatesAlso: submucosal conchectomysurgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates | Procedure or surgery | A2 |
Primary outcome
quality of life
Time frame: 1 year
1 secondary outcome
rhinomanometry, saccharine test, nasal endoscopy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2008.
- Results publication: PubMed 11089995Fradis 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 publication: PubMed 1999659Williams 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nili segal, md principal investigator
soroka university medical center beer sheva israel
Questions about this trial
What is this clinical trial studying?
A study testing bilateral nasal inferior turbinectomy and endoscopic submucosal resection of the inferior turbinates in people with Bilateral Inferior Turbinates Hypertrophy, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nili segal, md (+972544268202, segalna@012.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00651092, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2008.