NCT06264089

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

September 28, 2023

Last Update Submit

February 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reformatted coronal Computed tomography

    12 month

Study Arms (1)

No Arms have been specified for this study

OTHER

No Arms have been specified for this study

Procedure: Preservation Rhinoplasty Nasal Valve Angle and Area

Interventions

The same group of patients who underwent Preservation Rhinoplasty will be followed and the nasal valve angles before and after surgery will be compared.

Also known as: Preservation Rhinoplasty
No Arms have been specified for this study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preservation rhinoseptoplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yaser Said Cetin

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Amino Acid Motifs

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Protein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical PhenomenaProtein Structure, Secondary

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2023

First Posted

February 16, 2024

Study Start

August 6, 2020

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations