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临床试验/NCT02231216
NCT02231216已完成不适用

The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3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
2
主要终点
Quality of life related to nasal obstruction

研究概览

简要总结

Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate?

  • Population: patients eligible for functional rhinoseptoplasty and / or aesthetic
  • Intervention: surgery, turbinectomy of inferior turbinates
  • Comparison: the absence of intervention in inferior turbinates
  • Primary endpoint: Quality of life related to nasal obstruction

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
Single (Participant)

入排标准

年龄范围
6 Months 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible patients to rhinoseptoplasty
  • Patients who agreed to participate

排除标准

  • Presence of symptoms of nasal obstruction in the absence of septal deviation, poor support of the nasal tip or clamping of the nasal valve;
  • Presence of hypertrophic and obstructive inferior turbinates;
  • Presence of sinonasal tumors;
  • Patients undergoing treatment of other concomitant rhinoplasty entities such as inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and blepharoplasty.

研究组 & 干预措施

Rhinoseptoplasty and turbinectomy

Experimental

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

干预措施: Rhinoseptoplasty (Procedure)

Rhinoseptoplasty and turbinectomy

Experimental

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

干预措施: Partial turbinectomy (Procedure)

Rhinoseptoplasty and turbinectomy

Experimental

Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.

干预措施: Endoscopic partial turbinectomy (Procedure)

Rhinoseptoplasty

Active Comparator

Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.

干预措施: Rhinoseptoplasty (Procedure)

结局指标

主要结局

Quality of life related to nasal obstruction

时间窗: 3 months

Quality of life will be evaluated by the WHOQOL-BREF instrument, that comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.

次要结局

  • Topical Nasal Corticosteroids(3 MONTHS)
  • Nasal sneezing(3 MONTHS)
  • Nasal Rhinorrhea(3 MONTHS)
  • Nasal Pruritis(3 MONTHS)
  • Allergic Conjunctivitis(3 months)
  • Oral antihistamine(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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