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临床试验/NCT07412340
NCT07412340尚未招募不适用

Disarticulation Septoplasty Versus Classical Septoplasty: Retrospective Study

Hôpital NOVO1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results to correct symptomatic nasal septum deviations

研究概览

简要总结

The objective of this study is to determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results for correcting symptomatic deviations of the nasal septum.

More specifically it's about:

  • Compare the improvement in respiratory symptoms between the two techniques
  • Analyze and compare complication rates between the two techniques
  • Evaluate patient satisfaction with aesthetic results (including columella deviation)

详细描述

Nowadays, disarticulation septoplasty is recognized as an effective technique for correcting complex septal deviations. It allows better exposure of the nasal septum, which facilitates the correction of severe deformities and reduces post-operative complications. This method is often compared to open surgery, which remains a classic approach but perhaps less suited to cases of severe or complex deviations. This technique makes it possible to correct aesthetic deviations while improving the functional aspect avoiding an open path.

There are several questionnaires, particularly in the field of rhinology, to evaluate the results of this technique on nasal obstruction in an objective and subjective manner, therefore its impact on quality of life as well as its effectiveness on chronic nasal dysfunction caused by deviation of the nasal septum. In this study, in addition to nasal symptoms before and after surgery and postoperative complications, we chose to work with two scores; NOSE score as a valid, reliable and responsive self-report instrument to quantify subjective dysfunction related to nasal obstruction. The other score is NAFEQ score which makes it possible to evaluate the aesthetic and functional outcome after nasal reconstruction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patient aged 18 and over
  • Patient undergoing a new disarticulation septoplasty, or an open approach for nasal obstruction due to a deviated nasal septum, confirmed by endoscopy
  • Patient operated between 01/01/2023 and 31/12/2025

排除标准

  • Patient undergoing surgery but with the following medical history (on the day of surgery):
  • Patient with septal perforations
  • Patient with previous nasal septum surgery or cosmetic rhinoplasty
  • Patient with allergic rhinitis
  • Patient with chronic sinusitis
  • Patient with concha bullosa
  • Refusal to participate

结局指标

主要结局

To determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results to correct symptomatic nasal septum deviations

时间窗: Before and at least 3 months after the operation

Comparison of functional improvement in nasal breathing between the two techniques (disarticulation septoplasty versus classic septoplasty), using the standardized NOSE score routinely completed by patients pre-operatively and then 3 months post-operation.

次要结局

  • Compare the functional improvement between the two techniques, using a different tool(Before and at least 3 months after the operation)
  • Compare the improvement in respiratory symptoms between the two techniques(Before and at least 3 months after the operation)
  • Analyze and compare the complication rates between the two techniques(At day 15 and 3 months after the operation)
  • Assess patient satisfaction with aesthetic results (including columellar deviation)(Before and at least 3 months after the operation)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (1)

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