NCT07481045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 9, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

Septorhinoplasty, Inferior turbinate hypertrophy, Nasal obstruction, Peak nasal inspiratory flowmeter, NOSE score

Outcome Measures

Primary Outcomes (1)

  • Change in Nasal Obstruction Symptom Evaluation (NOSE) score

    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.

    Preoperative baseline and 6 months after surgery

Secondary Outcomes (1)

  • Change in Peak Nasal Inspiratory Flow (PNIF)

    Preoperative baseline and 6 months after surgery

Study Arms (2)

SRP

EXPERIMENTAL

Patients undergoing standard open functional septorhinoplasty without inferior turbinate intervention.

Procedure: Septorhinoplasty

SRP + CIT Surgery

EXPERIMENTAL

Patients undergoing septorhinoplasty combined with compensatory inferior turbinate surgery.

Procedure: SeptorhinoplastyProcedure: Inferior Turbinate Surgery

Interventions

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.

SRPSRP + CIT Surgery

Inferior turbinate reduction was performed on the non-deviated side using submucosal radiofrequency ablation followed by turbinate lateralization to improve nasal airway patency.

SRP + CIT Surgery

Eligibility Criteria

Age18 Years - 53 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Zülküf Küçüktağ, M.D.

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The investigator responsible for postoperative outcome assessment was blinded to the treatment allocation. Surgical procedures were performed by a single surgeon who was aware of the intervention. Participants were not blinded to the type of procedure performed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized in a 1:1 ratio to undergo either septorhinoplasty (SRP) alone or septorhinoplasty combined with compensatory inferior turbinate (CIT) surgery. Functional outcomes are compared between the two parallel groups using both subjective and objective measures during the postoperative follow-up period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 18, 2026

Study Start

January 1, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data.

Locations