Effects of Preservation Rhinoplasty Nasal Valve Angle and Area

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

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction, Bilateral
• Intervention / Treatment: Procedure: Preservation Rhinoplasty Nasal Valve Angle and Area

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Yaser Said Cetin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Preservation rhinoseptoplasty

Exclusion Criteria:

• Absence of nasal obstruction
• Previous nasosinusal surgery
• Cranio-facial anomalies
• Presence of nasosinusal tumors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No Arms have been specified for this study	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.; Other Names: Preservation Rhinoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 202015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No