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临床试验/NCT07731152
NCT07731152尚未招募不适用

Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction

Sohag University0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Improvement in nasal obstruction symptoms

研究概览

简要总结

This prospective comparative study aims to evaluate the outcomes of septoplasty with or without inferior turbinate reduction in patients with symptomatic deviated nasal septum. Subjective and objective outcomes will be assessed using the NOSE score, Peak Nasal Inspiratory Flow (PNIF), and nasal endoscopic examination before and after surgery.

详细描述

This prospective comparative study will be conducted at the Department of Otolaryngology, Sohag University Hospital. The study aims to compare the outcomes of septoplasty alone versus septoplasty combined with inferior turbinate reduction in adult patients with symptomatic deviated nasal septum and persistent nasal obstruction. Forty patients will be enrolled and allocated into two groups. Clinical outcomes will be evaluated preoperatively and at 1 month and 3 months postoperatively using the Nasal Obstruction Symptom Evaluation (NOSE) score, Peak Nasal Inspiratory Flow (PNIF), and diagnostic nasal endoscopy. The primary outcome is improvement in nasal obstruction symptoms, while secondary outcomes include changes in NOSE score, PNIF measurements, and endoscopic findings.

研究设计

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

盲法说明

No masking will be applied. Both participants and investigators will be aware of the surgical intervention performed.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with symptomatic deviated nasal septum causing persistent nasal obstruction, aged 18-50 years, who failed medical treatment for at least 3 months, will be included in the study.

排除标准

  • Patients with previous nasal surgery, nasal polyposis, chronic rhinosinusitis, alar collapse, uncontrolled allergic rhinitis, nasal tumors, or external nasal deformity requiring rhinoplasty will be excluded from the study.

结局指标

主要结局

Improvement in nasal obstruction symptoms

时间窗: Baseline (preoperative), 1 month postoperative, and 3 months postoperative

Assessment of improvement in nasal obstruction symptoms after surgery using the Nasal Obstruction Symptom Evaluation (NOSE) score.

次要结局

  • Change in NOSE score(Baseline, 1 month postoperative, and 3 months postoperative)
  • Change in Peak Nasal Inspiratory Flow (PNIF)(Baseline, 1 month postoperative, and 3 months postoperative)
  • Endoscopic nasal examination findings(Baseline, 1 month postoperative, and 3 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mena Mikhael Roshdy

Mena Mikhael Roshdy

Sohag University

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