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Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum

2016年1月10日 更新者:SHOROOK NA'ARA MD、Rambam Health Care Campus

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:

  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.

研究概览

详细说明

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:

  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.

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  1. Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
  2. Patients undergoing endoscopic sinonasal surgery.
  3. Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
  4. Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
  5. Patients listed for revision surgery
  6. Neoplasms - untreated or under active or recent treatment with chemotherapy or radiotherapy
  7. Unable to give informed consent due to mental impairment
  8. Unable to adhere follow up or treatment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Traditional
a control arm of patients undergoing traditional septoplasty for DNS
septoplasty under direct vision
实验性的:Endoscopic
patients undergoing endoscopic septoplasty.
Endoscopic surgery; septoplasty with or without middle turbenectomy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Quality of life
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年2月1日

初级完成 (预期的)

2019年2月1日

研究注册日期

首次提交

2016年1月6日

首先提交符合 QC 标准的

2016年1月10日

首次发布 (估计)

2016年1月13日

研究记录更新

最后更新发布 (估计)

2016年1月13日

上次提交的符合 QC 标准的更新

2016年1月10日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0576-15-RMB

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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