Effects of Preservation Rhinoplasty Nasal Valve Angle and Area

Nasal Obstruction, Bilateral Clinical Trial

Official title:

Effects of Preservation Rhinoplasty Nasal Valve Angle and Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06264089
• Other study ID #: 202015
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery.

Description:

Nasal congestion is one of the most common complaints in Otorhinolaryngology medicine. One of the most common causes of this is the collapse or blockage of the Internal Nasal Valve (INV). The internal nasal valve is the narrowest part of the airway and creates the greatest resistance to airflow. Its most important function is to regulate the inspiratory airflow. It is determined by the angle formed between the caudal part of the upper lateral cartilage and the nasal septal cartilage. This angle normally varies between 9-15 degrees. The tip of the inferior turbinate and the tissues surrounding the piriform aperture may affect this area. When this angle is less than 9 degrees, the valve collapses in inspiration. The internal nasal valve region should be evaluated in every patient complaining of nasal congestion. the investigators planned to radiologically examine the improvement in the internal nasal valve angle of the patients we operated on.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Preservation rhinoseptoplasty

Exclusion Criteria:

• Absence of nasal obstruction

• Previous nasosinusal surgery

• Cranio-facial anomalies

• Presence of nasosinusal tumors

Related Conditions & MeSH terms

• Nasal Obstruction
• Nasal Obstruction, Bilateral

Intervention

Procedure:
• Preservation Rhinoplasty Nasal Valve Angle and Area
The same group of patients who underwent Preservation Rhinoplasty will be followed and the nasal valve angles before and after surgery will be compared.

Locations

Country	Name	City	State
Turkey	Yaser Said Cetin	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Obstruction Symptom Evaluation Scale (NOSE)	Nasal Obstruction Symptom Evaluation Scale (NOSE); The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at the end of 12 months.	12 month
Secondary	Reformatted coronal Computed tomography	The internal and external nasal valve levels of patients scheduled for septorhinoplasty surgery will be prospectively examined preoperatively and postoperatively with a high-resolution 3-plan (axial-sagittal-coronal) CT study. Axial CT studies will be obtained with the latest generation, 128-channel, multi-slice CT scanners (Siemens SOMATOM Definition AS+128, Forchheim, Germany) with a slice thickness of 0.5 to 1.25 mm in the bone algorithm. Axial slices will be acquired from the top of the frontal sinuses to the bottom of the maxillary incisors. Studies will be made from random selections and without correlation to diagnosis or indication.; Axial data will be transferred to the workstation (Siemens Syngo Via Workstation) for postprocessing and measurements will be performed on this workstation.	12 month