- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481045
Compensatory Inferior Turbinate Surgery in Septorhinoplasty (CIT)
Effect of Concomitant Compensatory Inferior Turbinate Surgery on Functional Outcomes After Septorhinoplasty: A Randomized Controlled Trial
Nasal obstruction is a common complaint among patients undergoing septorhinoplasty. In addition to septal deviation, compensatory inferior turbinate hypertrophy may contribute to impaired nasal airflow. For this reason, some surgeons routinely perform inferior turbinate reduction during septorhinoplasty. However, the necessity and functional benefit of this additional procedure remain controversial.
The aim of this randomized controlled study is to evaluate whether compensatory inferior turbinate surgery provides additional functional benefit when performed simultaneously with septorhinoplasty. Patients undergoing septorhinoplasty will be randomly assigned to either septorhinoplasty alone or septorhinoplasty combined with inferior turbinate surgery.
Functional outcomes will be assessed using both subjective and objective measures. Subjective nasal obstruction will be evaluated using the Nasal Obstruction Symptom Evaluation (NOSE) scale, and objective nasal airflow will be assessed using peak nasal inspiratory flow (PNIF). Patients will be followed for six months after surgery.
The results of this study are expected to clarify the role of compensatory inferior turbinate surgery in patients undergoing septorhinoplasty and provide evidence regarding whether routine turbinate intervention is necessary in this patient population.
Study Overview
Status
Intervention / Treatment
Detailed Description
Nasal obstruction is a common complaint among patients with nasal septal deviation and is one of the major indications for septorhinoplasty. Although correction of septal deviation often improves nasal airflow, some patients present with compensatory inferior turbinate hypertrophy that may contribute to persistent nasal obstruction. For this reason, inferior turbinate surgery is frequently performed during septorhinoplasty. However, the additional functional benefit of routine turbinate intervention in these patients remains controversial.
This prospective randomized controlled study aims to evaluate the effect of compensatory inferior turbinate surgery on functional outcomes in patients undergoing septorhinoplasty. Patients with nasal obstruction due to septal deviation who are scheduled for septorhinoplasty will be enrolled and randomly assigned to one of two treatment groups: septorhinoplasty alone or septorhinoplasty combined with inferior turbinate surgery.
All surgical procedures will be performed using standard septorhinoplasty techniques. In the intervention group, inferior turbinate reduction will be performed during the same surgical session. Postoperative functional outcomes will be evaluated using both subjective and objective assessment tools. Subjective nasal obstruction will be assessed with the Nasal Obstruction Symptom Evaluation (NOSE) scale, and objective nasal airflow will be measured using peak nasal inspiratory flow (PNIF).
Patients will be followed for six months after surgery. Functional outcomes will be compared between the two groups to determine whether additional inferior turbinate surgery provides clinically meaningful improvement in nasal airway function when performed simultaneously with septorhinoplasty.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06010
- Etlik City Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients older than 18 years
- Patients presenting with nasal obstruction and aesthetic concerns requiring septorhinoplasty
- Presence of nasal septal deviation confirmed by anterior rhinoscopy, nasal endoscopy, or computed tomography
- Presence of compensatory inferior turbinate hypertrophy in the contralateral nasal cavity
- Patients willing to participate and able to provide informed consent
Exclusion Criteria:
- Previous nasal, septal, or turbinate surgery
- Chronic rhinosinusitis with or without nasal polyps
- Bilateral inferior turbinate hypertrophy
- Absence of compensatory inferior turbinate hypertrophy
- Patients requiring additional nasal procedures or grafting techniques beyond the standardized surgical protocol
- Incomplete follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SRP
Patients undergoing standard open functional septorhinoplasty without inferior turbinate intervention.
|
Standard open functional septorhinoplasty was performed under general anesthesia, including septoplasty, dorsal profile alignment with transverse and lateral osteotomies, tipplasty, bilateral spreader graft placement, and columellar strut grafting.
Silicone nasal splints were placed bilaterally and removed after 72 hours.
|
|
Experimental: SRP + CIT Surgery
Patients undergoing septorhinoplasty combined with compensatory inferior turbinate surgery.
|
Standard open functional septorhinoplasty was performed under general anesthesia, including septoplasty, dorsal profile alignment with transverse and lateral osteotomies, tipplasty, bilateral spreader graft placement, and columellar strut grafting.
Silicone nasal splints were placed bilaterally and removed after 72 hours.
Inferior turbinate reduction was performed on the non-deviated side using submucosal radiofrequency ablation followed by turbinate lateralization to improve nasal airway patency.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nasal Obstruction Symptom Evaluation (NOSE) score
Time Frame: Preoperative baseline and 6 months after surgery
|
The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated patient-reported questionnaire used to assess the severity of nasal obstruction.
Scores range from 0 to 100, with higher scores indicating more severe nasal obstruction.
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Preoperative baseline and 6 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peak Nasal Inspiratory Flow (PNIF)
Time Frame: Preoperative baseline and 6 months after surgery
|
Peak Nasal Inspiratory Flow (PNIF) is an objective measure of nasal airflow.
|
Preoperative baseline and 6 months after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zülküf Küçüktağ, M.D., Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-BADEK1-2025-327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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