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临床试验/NCT03666130
NCT03666130Unknown不适用

Endoscopic Versus Conventional Septoplasty in the Treatment of Deviated Nasal Septum

Assiut University0 个研究点目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
The percentage of patients free from symptoms after surgery

研究概览

简要总结

This study aims to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation and /or other postoperative complications following each techniques of surgery.

详细描述

A straight septum is found not to be the dominant but the exception.

A deviated septum can be asymptomatic or can cause functional and cosmetic abnormality. it also can become symptomatic at any age. Deviated nasal septum not only causes breathing difficulties but also causes improper aeration of para nasal sinuses leading to infection, so any functional or cosmetic disturbance caused by a deviated septum should be treated. Different surgeries have been proposed for the correction of deviated nasal septum. Initially, submucosal resection of septum was proposed but was later replaced by septoplasty .

Septoplasty is the procedure of choice in nasal obstruction caused by septal deviation resistant to medical treatment. It also improves access to the medial meatus in sinus surgery and other nasal and sinus procedures, such as cosmetic rhinoplasty and functional endoscopic sinus surgery(FESS)

Modern septoplasty techniques were initially described separately in the early twenties century by Killian and Freer. It is conventionally performed under direct visualization using a headlight and nasal speculum. However, this method has the drawbacks of relatively poor illumination and accessibility and no magnification, calling for a larger incision and elevation of larger flaps often on both sides of the septum. As a result, there are higher chances of over-resection and over manipulation. Endoscopic septoplasty has been commonly performed since the development of endonasal surgery and as as an alternative to the conventional technique. In this study the I investigators aim to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation following each techniques of surgery.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with deviated nasal septum with persistent symptoms for at least 3 months and had not responded to maximal medical management.
  • patients of deviated nasal septum cased by either childbirth trauma or recent

排除标准

  • patients of asymptomatic deviated nasal septum
  • patients who had a history of previous nasal surgery
  • patients who had other causes of nasal obstruction
  • patients who had received radiotherapy of head and neck region.

研究组 & 干预措施

endoscopic septoplasty

Active Comparator

in this arm the participants will undergo endoscopic septoplasty for correction of the deviated nasal septum

干预措施: endoscopic septoplasty (Procedure)

conventional septoplasty

Active Comparator

in this arm the participants will undergo conventional septoplasty operation for correction of the deviated nasal septum that will done by surgical traditional septoplasty technique using head lamb and anterior rhinoscopy

干预措施: endoscopic septoplasty (Procedure)

结局指标

主要结局

The percentage of patients free from symptoms after surgery

时间窗: 3 months

the relive of the nasal obstruction symptoms as difficult breathing and nasal discharge and the complication of each method of surgery as synechia formation and postoperative bleeding

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

Mostafa Mahrous

Institutional Review Board (IRB) of faculty of medicine

Assiut University

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