Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum
Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial
In this study the investigators aim to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary outcomes:
- To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
- To evaluate the differences in the operation time between the two different approaches.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Nasal obstruction is one of the most common complaints that the otorhinolaryngologist faces in the daily practice. Deviated nasal septum (DNS) is a very frequently encountered and common cause. It not only causes breathing difficulties but also results in improper aeration of paranasal sinuses predisiposing to sinusitis and also results in drying of mucosa leading to crusting and epistaxis 1,2. DNS can also be accompanied with hypertrophic nasal turbinates causing sleep disturbances and snoring3.
Septoplasty is an accepted and common surgical intervention to improve the nasal airway4 and sleep disturbances3.
Traditional septoplasty procedure involves sum mucosal resection of the anterior septum. The results for long-term symptom relief after traditional septoplasty are contradictory in reviewed publications 5.
In the last two decades the endoscopic Sino nasal surgery has been widely used including endoscopic approach for septoplasty. Endoscopic septoplasty as a minimally invasive technique where the dissection of the nasal septal flap can be limited minimizing trauma. The excellent visualization is presumed to decrease morbidity and post-operative swelling in isolated septal deviation by limiting the excision to the area of deviation 2. Furthermore, diagnosing and treating abnormalities of the lateral wall of the nose at the same sitting is only feasible in the endoscopic approach.
At the time of this study, there are no studies comparing the changes of quality of life in patients undergoing traditional septoplasty Vs endoscopic septoplasty.
The investigators aimed to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Aims
Primary:
1) To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary:
- To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
- To evaluate the differences in the operation time between the two different approaches.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
- Patient undergoing surgery for repairing the deviated nasal septum.
Exclusion Criteria:
- Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
- Patients undergoing endoscopic sinonasal surgery.
- Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
- Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
- Patients listed for revision surgery
- Neoplasms - untreated or under active or recent treatment with chemotherapy or radiotherapy
- Unable to give informed consent due to mental impairment
- Unable to adhere follow up or treatment.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Traditional
a control arm of patients undergoing traditional septoplasty for DNS
|
septoplasty under direct vision
|
|
Экспериментальный: Endoscopic
patients undergoing endoscopic septoplasty.
|
Endoscopic surgery; septoplasty with or without middle turbenectomy
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Quality of life
Временное ограничение: Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.
|
quality of life will assessed using Sino-Nasal Outcome Test-22 (SNOT-22) scores.
|
Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 0576-15-RMB
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