跳至主要内容
临床试验/NCT02653950
NCT02653950Unknown不适用

Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial

Rambam Health Care Campus0 个研究点目标入组 60 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Change in Quality of life

研究概览

简要总结

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:

  1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
  2. To evaluate the differences in the operation time between the two different approaches.

详细描述

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.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
  • Patient undergoing surgery for repairing the deviated nasal septum.

排除标准

  • 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.

结局指标

主要结局

Change in Quality of life

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SHOROOK NA'ARA MD

MD

Rambam Health Care Campus

相似试验