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Набор скоро начнётся NCT07412340

Disarticulation Septoplasty Versus Classical Way

— Наблюдательное Nasal Septum Deviation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice.
Кому может быть актуально
Состояния в реестре: Nasal Septum Deviation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Disarticulation Septoplasty Versus Classical Septoplasty: Retrospective Study

Обзор

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)

Подробное описание

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.

Вмешательства

  • Другое Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice
    Comparison of functional improvement in nasal breathing between the two techniques using questionnaires administered to patients by their practitioners in routine practice

Первичные конечные точки

  • To determine which of the two techniques (disarticulation septoplasty versus open surgery) offers the best functional results to correct symptomatic nasal septum deviations [Срок оценки: Before and at least 3 months after the operation]
Вторичные конечные точки (4)
  • Compare the functional improvement between the two techniques, using a different tool [Срок оценки: Before and at least 3 months after the operation]
  • Compare the improvement in respiratory symptoms between the two techniques [Срок оценки: Before and at least 3 months after the operation]
  • Analyze and compare the complication rates between the two techniques [Срок оценки: At day 15 and 3 months after the operation]
  • Assess patient satisfaction with aesthetic results (including columellar deviation) [Срок оценки: Before and at least 3 months after the operation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hopital Novo — Pontoise

Публикации

  • Jankowski R, Gallet P, Nguyen DT, Rumeau C. Septoplasty by disarticulation. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Nov;137(5):423-426. doi: 10.1016/j.anorl.2020.07.014. Epub 2020 Oct 2. PMID 33020044

Идентификаторы

NCT: NCT07412340 · CHRD 1925

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗