An interventional study of Septoplasty with Mucotomy and Septoplasty with Turbinectomy in Nasal Patency, Breathing Disorder During Sleeping and Breathing Mechanics, sponsored by University Hospital Sestre Milosrdnice. Enrolling by invitation at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by University Hospital Sestre Milosrdnice · Not applicable, Interventional, and Treatment
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.
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).
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's planned enrollment of 90 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Hospital Sestre Milosrdnice is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Septoplasty accompanied by radiofrequent mucotomy of the inferior nasal turbinates.
Procedure: Septoplasty with Valvuloplasty
Septoplasty accompanied by surgical resection of the inferior nasal turbinates.
Procedure: Septoplasty with Mucotomy
Septoplasty accompanied by placing a flaring sutture in the internal nasal valve area.
Procedure: Septoplasty with Turbinectomy
Subtotal reconstruction of the nasal septum accompanied by radiofrequent nasal mucosal reduction of the inferior turbinates.
Subtotal reconstruction of the nasal septum accompanied by surgical resection of the inferior turbinates.
Subtotal reconstruction of the nasal septum accompanied by surgical intervention by placing a flare sutture in the internal nasal valve area.
PNIF
Peak Nasal Inspiratory Flow measurement - objective measurement of nasal patency in liters per minute.
Time frame: Every months until six months postoperatively.
NOSE questionnaire
Validated PROM regarding subjective nasal patency assessment.
Time frame: Every month up to 6 months post surgery.
Plan to share: No
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University Hospital Sestre Milosrdnice