跳至主要内容
临床试验/NCT01457638
NCT01457638已完成不适用

Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life and Acoustic Rhinometry Outcomes

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Nasal Obstructive Symptoms Evaluation Scale

研究概览

简要总结

The purpose of this study is to determine whether inferior turbinate surgery during rhinoseptoplasty is effective in improving quality of life and acoustic rhinometry outcomes.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Older than 15 years old;
  • Nasal obstruction and nasal aesthetics complaints;

排除标准

  • Previous septoplasty, turbinates intervention and/or rhinoplasty;
  • Association of other surgical procedures in the same surgical time, as functional endoscopic sinus surgery, blepharoplasty, mentoplasty or otoplasty;
  • Inferior turbinate hypertrophy as the isolated cause of nasal obstruction (no septum deviation or internal valve collapse)

研究组 & 干预措施

No inferior turbinate surgery

Sham Comparator

During rhinoseptoplasty there is no intervention on inferior turbinates

干预措施: No iInferior turbinate surgery (Procedure)

Inferior Turbinate surgery

Experimental

During rhinoseptoplasty, inferior turbinate submucosal cauterization is performed.

干预措施: Inferior turbinate surgery (Procedure)

结局指标

主要结局

Nasal Obstructive Symptoms Evaluation Scale

时间窗: 3 months postop

Specif instrument for evaluation of quality of life related to nasal obstruction

次要结局

  • Acoustic Rhinometry(3 months post-op)
  • World Health Organization Quality of Life (WHOQOL)(3 months postop)
  • Rhinoplasty Outcomes Evaluation(3 months postop)
  • Allergic Conjunctivitis(3 months postop)
  • Nasal Rhinorrea(3 months postop)
  • Nasal pruritis(3 months posopt)
  • Nasal Sneeze(3 months postop)
  • Topic nasal corticosteroid(3 months)
  • Oral antihistamine(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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