Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Not Applicable

Completed

• Conditions: Nasal Septum; Deviation; Nasal Mucosa Hypertrophy; Nasal Obstruction
• Interventions: Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty; Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

• Registration Number: NCT04220853
• Lead Sponsor: University Hospital Ostrava

Brief Summary

Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery.

The aim of the study is to examine nasal airflow parameters after septoplasty and turbinoplasty .

Detailed Description

Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery.

The aim of the study is to examine nasal airflow parameters at pre-defined intervals in patients after septoplasty and turbinoplasty .

Study Timeline

• Study First Submitted: 2019-09-04
• Study Start: 2019-10-01
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients with nasal obstruction (nasal septal deviation, hypertrophy of nasal mucosa)
• 18 to 70 Years
• patient capable of general anesthesia
• signing of the informed consent

Exclusion Criteria

• patient incapable of general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Septoplasty	Rhinomanometry in patients after septoplasty and/or turbinoplasty	The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Turbinoplasty	Acoustic rhinometry in patients after septoplasty and/or turbinoplasty	The patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Septoplasty and turbinoplasty	Acoustic rhinometry in patients after septoplasty and/or turbinoplasty	The patients indicated for septoplasty and turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Septoplasty	Acoustic rhinometry in patients after septoplasty and/or turbinoplasty	The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Turbinoplasty	Rhinomanometry in patients after septoplasty and/or turbinoplasty	The patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Septoplasty and turbinoplasty	Rhinomanometry in patients after septoplasty and/or turbinoplasty	The patients indicated for septoplasty and turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.

Primary Outcome Measures

Name	Time	Method
Changes in airflow	6 and 12 weeks after surgery	Changes in airflow (measured in ml/s - millilitres/second) will be assessed with rhinomanometry 6 and 12 weeks after surgery.
Changes in resistance	6 and 12 weeks after surgery	Changes in resistance (measured in Pa-s/ml - Pascal-second/millilitre) will be assessed with rhinomanometry 6 and 12 weeks after surgery.
Changes in the cross-sectional area of the nasal passage	6 and 12 weeks after surgery	Changes in the cross-sectional area of the nasal passage will be assessed with acoustic rhinometry 6 and 12 weeks after surgery.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia