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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Traditional
a control arm of patients undergoing traditional septoplasty for DNS
|
septoplasty under direct vision
|
|
Experimental: Endoscopic
patients undergoing endoscopic septoplasty.
|
Endoscopic surgery; septoplasty with or without middle turbenectomy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Quality of life
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 0576-15-RMB
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