Nasal Obstruction, BilateralNCT06264089
Effects of Preservation Rhinoplasty Nasal Valve Angle and Area
A study testing Preservation Rhinoplasty Nasal Valve Angle and Area in people with Nasal Obstruction, Bilateral, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction, Bilateral
- What is being tested?
- Preservation Rhinoplasty Nasal Valve Angle and Area
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2020to 30 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preservation rhinoseptoplasty
Who cannot join
- Absence of nasal obstruction
- Previous nasosinusal surgery
- Cranio-facial anomalies
- Presence of nasosinusal tumors
Trial locations and contacts
1 site in 1 country.
About this study
The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery.
Read the detailed description
Nasal congestion is one of the most common complaints in Otorhinolaryngology medicine. One of the most common causes of this is the collapse or blockage of the Internal Nasal Valve (INV). The internal nasal valve is the narrowest part of the airway and creates the greatest resistance to airflow. Its most important function is to regulate the inspiratory airflow. It is determined by the angle formed between the caudal part of the upper lateral cartilage and the nasal septal cartilage. This angle normally varies between 9-15 degrees. The tip of the inferior turbinate and the tissues surrounding the piriform aperture may affect this area. When this angle is less than 9 degrees, the valve collapses in inspiration. The internal nasal valve region should be evaluated in every patient complaining of nasal congestion. the investigators planned to radiologically examine the improvement in the internal nasal valve angle of the patients we operated on.
- Conditions
- Nasal Obstruction, Bilateral
- Being tested
- Preservation Rhinoplasty Nasal Valve Angle and Area
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservation Rhinoplasty Nasal Valve Angle and AreaProcedure or surgery
Also called Preservation Rhinoplasty
The same group of patients who underwent Preservation Rhinoplasty will be followed and the nasal valve angles before and after surgery will be compared.
| Study group | Role | What they receive |
|---|---|---|
| No Arms have been specified for this study | Other | No Arms have been specified for this study Receives: Procedure: Preservation Rhinoplasty Nasal Valve Angle and Area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction Symptom Evaluation Scale (NOSE)
Nasal Obstruction Symptom Evaluation Scale (NOSE)
The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at the end of 12 months.
Measured: 12 month
Secondary outcomes (1)
Reformatted coronal Computed tomography
The internal and external nasal valve levels of patients scheduled for septorhinoplasty surgery will be prospectively examined preoperatively and postoperatively with a high-resolution 3-plan (axial-sagittal-coronal) CT study. Axial CT studies will be obtained with the latest generation, 128-channel, multi-slice CT scanners (Siemens SOMATOM Definition AS+128, Forchheim, Germany) with a slice thickness of 0.5 to 1.25 mm in the bone algorithm. Axial slices will be acquired from the top of the frontal sinuses to the bottom of the maxillary incisors. Studies will be made from random selections and without correlation to diagnosis or indication.
Axial data will be transferred to the workstation (Siemens Syngo Via Workstation) for postprocessing and measurements will be performed on this workstation.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start6 Aug 2020
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Obstruction, BilateralStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaser Said Cetin, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264089
- Sponsor's protocol ID
- 202015
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preservation Rhinoplasty Nasal Valve Angle and Area
- ClinicalTrials.gov ID
- NCT06264089
- Acronym / sponsor ID
- 202015
- Conditions
- Nasal Obstruction, Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 16 Feb 2024 (actual)
- 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 study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery.
Detailed description
Nasal congestion is one of the most common complaints in Otorhinolaryngology medicine. One of the most common causes of this is the collapse or blockage of the Internal Nasal Valve (INV). The internal nasal valve is the narrowest part of the airway and creates the greatest resistance to airflow. Its most important function is to regulate the inspiratory airflow. It is determined by the angle formed between the caudal part of the upper lateral cartilage and the nasal septal cartilage. This angle normally varies between 9-15 degrees. The tip of the inferior turbinate and the tissues surrounding the piriform aperture may affect this area. When this angle is less than 9 degrees, the valve collapses in inspiration. The internal nasal valve region should be evaluated in every patient complaining of nasal congestion. the investigators planned to radiologically examine the improvement in the internal nasal valve angle of the patients we operated on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Arms have been specified for this study | Other | Procedure: Preservation Rhinoplasty Nasal Valve Angle and AreaNo Arms have been specified for this study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Preservation rhinoseptoplasty
Key exclusion criteria (4 listed)
- Absence of nasal obstruction
- Previous nasosinusal surgery
- Cranio-facial anomalies
- Presence of nasosinusal tumors
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 |
|---|---|---|
| Preservation Rhinoplasty Nasal Valve Angle and AreaAlso: Preservation RhinoplastyThe same group of patients who underwent Preservation Rhinoplasty will be followed and the nasal valve angles before and after surgery will be compared. | Procedure or surgery | No Arms have been specified for this study |
Primary outcome
Nasal Obstruction Symptom Evaluation Scale (NOSE)
Time frame: 12 month
Nasal Obstruction Symptom Evaluation Scale (NOSE) The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at the end of 12 months.
1 secondary outcome
Reformatted coronal Computed tomography
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservation Rhinoplasty Nasal Valve Angle and Area in people with Nasal Obstruction, Bilateral, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Obstruction Symptom Evaluation Scale (NOSE) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024.