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临床试验/NCT07127848
NCT07127848Enrolling By Invitation不适用

Comparing Outcomes in Patients Who Underwent Septoplasty With Mucotomy, Turbinectomy, Or Valvuloplasty

University Hospital Sestre Milosrdnice2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
90
试验地点
2
主要终点
PNIF

研究概览

简要总结

The aim of this study will be to compare postoperative nasal airflow and symptom improvement using a NOSE form in patients after different types of surgical treatment. Patients will be treated with one of the following operations: septoplasty with turbinectomy, septoplasty with radiofrequent ablation of the nasal turbinates, or septoplasty with valvuloplasty.

This is a single-center prospective randomized interventional comparative study on patients in a tertiary rhinology center, who will undergo septoplasty alongside one additional rhinologic procedure aimed at improving nasal patency.

详细描述

Inclusion criteria will be met if patients are 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates. The criteria require complete follow-up during the testing phases, complete documentation, written informed consent and all questionnaire-related data to be complete.

The patients will be divided into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates. Randomization will be performed via a binary coin-toss method, with allocation con-cealment, and using a heads-tails method on a true random number generator online service (TRNG).

Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis will be excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.

Written informed consent will be obtained from all of the eligible patients. Primary outcome measures include subjective NOSE (Nasal Obstruction Symptom Evaluation) questionnaire scores - internationally validated scale for assessment of intensity of nasal obstruction, consisting of 5 claims related to nasal obstruction divided into Likert scales of 4 points for each claim (normal values 2.75-7, with scores >7 indicating clinically relevant nasal obstruction), and objective peak nasal inspiratory flow measurements using a calibrated instrument (PNIF, GM Instruments, with normal values ranging from 130-140 l/min for healthy young adults), while anthropometric and demographic variables will be covariates[12].

PNIF is a noninvasive, easy to perform method commonly used to assess nasal patency. It is a physiologic measure indicating the peak nasal airflow in liters per minute achieved during maximal forced nasal inspiration [ ]. To reduce test-retest variability and sampling bias due to the influence of the elasticity of the lateral nasal wall (the valve effect), three PNIF measurements will be performed preoperatively and repeated at onset and three months postoperatively, with the best measurement recorded for data analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates.

排除标准

  • Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis were excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.

结局指标

主要结局

PNIF

时间窗: Every months until six months postoperatively.

Peak Nasal Inspiratory Flow measurement - objective measurement of nasal patency in liters per minute.

NOSE questionnaire

时间窗: Every month up to 6 months post surgery.

Validated PROM regarding subjective nasal patency assessment.

次要结局

未报告次要终点

研究者

发起方
University Hospital Sestre Milosrdnice
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andro Košec, MD, PhD

Consultant Otorhinolaryngologist and Head and Neck Surgeon

University Hospital Sestre Milosrdnice

研究点 (2)

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