Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Not Applicable

Completed

• Conditions: Nasal Septum; Deviation; Nasal Mucosa Hypertrophy; Nasal Obstruction

• 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

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