NCT07127848

Investingation on Outcomes After Combining Septoplasty With Additional Procedures.

Comparing Outcomes in Patients Who Underwent Septoplasty With Mucotomy, Turbinectomy, Or Valvuloplasty

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital Sestre Milosrdnice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study will be to compare postoperative nasal airflow and symptom improvement using a NOSE form in patients after different types of surgical treatment. Patients will be treated with one of the following operations: septoplasty with turbinectomy, septoplasty with radiofrequent ablation of the nasal turbinates, or septoplasty with valvuloplasty. This is a single-center prospective randomized interventional comparative study on patients in a tertiary rhinology center, who will undergo septoplasty alongside one additional rhinologic procedure aimed at improving nasal patency.

Detailed description

Inclusion criteria will be met if patients are 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates. The criteria require complete follow-up during the testing phases, complete documentation, written informed consent and all questionnaire-related data to be complete. The patients will be divided into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates. Randomization will be performed via a binary coin-toss method, with allocation con-cealment, and using a heads-tails method on a true random number generator online service (TRNG). Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis will be excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed. Written informed consent will be obtained from all of the eligible patients. Primary outcome measures include subjective NOSE (Nasal Obstruction Symptom Evaluation) questionnaire scores - internationally validated scale for assessment of intensity of nasal obstruction, consisting of 5 claims related to nasal obstruction divided into Likert scales of 4 points for each claim (normal values 2.75-7, with scores \>7 indicating clinically relevant nasal obstruction), and objective peak nasal inspiratory flow measurements using a calibrated instrument (PNIF, GM Instruments, with normal values ranging from 130-140 l/min for healthy young adults), while anthropometric and demographic variables will be covariates\[12\]. PNIF is a noninvasive, easy to perform method commonly used to assess nasal patency. It is a physiologic measure indicating the peak nasal airflow in liters per minute achieved during maximal forced nasal inspiration \[ \]. To reduce test-retest variability and sampling bias due to the influence of the elasticity of the lateral nasal wall (the valve effect), three PNIF measurements will be performed preoperatively and repeated at onset and three months postoperatively, with the best measurement recorded for data analysis. The study was designed to comply with CONSORT guidelines. A minimal study sample of 90 was calculated based on 80% study power and alpha error rate of 5% (G\*Power t-test).

Conditions

• Nasal Patency
• Breathing Disorder During Sleeping
• Breathing Mechanics

Interventions

Type	Name	Description
PROCEDURE	Septoplasty with Mucotomy	Subtotal reconstruction of the nasal septum accompanied by radiofrequent nasal mucosal reduction of the inferior turbinates.
PROCEDURE	Septoplasty with Turbinectomy	Subtotal reconstruction of the nasal septum accompanied by surgical resection of the inferior turbinates.
PROCEDURE	Septoplasty with Valvuloplasty	Subtotal reconstruction of the nasal septum accompanied by surgical intervention by placing a flare sutture in the internal nasal valve area.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-03
• Completion: 2025-09-03
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: Croatia