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临床试验/NCT03880890
NCT03880890Unknown不适用

(Value of Endoscopic Sphenoid Nasalization in Management of Allergic Fungal Sinusitis Involving Sphenoidal Sinus)

Assiut University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
rate of recurrence

研究概览

简要总结

To study the outcome of different two endoscopic sphenoid procedure for management of allergic fungal sphenoidal sinusitis : sphenoidotomy versus sphenoid nasalization with posterior septectomy .

详细描述

Fungal rhinosinusitis classified into invasive and noninvasive subtypes. Phenotypes of noninvasive fungal rhinosinusitis occur in immunocompetent subjects and include: local fungal colonization, fungal ball, and allergic fungal rhinosinusitis. Subtypes of invasive fungal rhinosinusitis include acute invasive fungal rhinosinusitis, chronic invasive fungal rhinosinusitis and granulomatous invasive rhinosinusitis.

The estimated incidence of sphenoid sinusitis is only 2.7% of all nasal sinus infections, also the diagnosis of sphenoid sinus fungal infection is sometimes difficult. Clinical signs are often non specific and nasal endoscopy can be strictly normal.Early diagnosis is therefore difficult and diagnosis is often delayed with headache that may sometimes persists for several years before diagnosis of the disease.

In most cases of sphenoid sinusitis, enlargement of the obstructed sinus ostium is sufficient to provide drainage of retained secretions and reestablish mucociliary clearance.According to Simmen and Jones, a type I sphenoidotomy entails identification of the ostium without further intervention; a type II sphenoidotomy entails enlargement of the ostium upward to the level of the cranial base, and inferiorly to one-half of the sinus height; and a type III sphenoidotomy involves widening the ostium to its most lateral extent.

Eloy et al in 2017 stuited that,In more extensive sphenoid sinus surgery is reserved for cases where in the disease process is extensive or previous surgery has failed. In some cases sphenoid nasalization in which bilateral extended sphenoidotomy is necessary. In this procedure, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway . It also allows access to the lateral recesses of this sinus.

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

性别
All
接受健康志愿者

入选标准

  • Any case of allergic fungal sinusitis unilateral or bilateral involving the sphenoid sinus

排除标准

  • Acute invasive fungal sinusitis.
  • Previous Sinonasal surgery.
  • Unfit patient for surgery.

研究组 & 干预措施

sphenoidotomy (group A)

Active Comparator

sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus

干预措施: sphenoidotomy versus sphenoid nasalisation (Procedure)

sphenoid nasalization (group B)

Active Comparator

sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .

干预措施: sphenoidotomy versus sphenoid nasalisation (Procedure)

结局指标

主要结局

rate of recurrence

时间窗: 6 month

To assess the effect of nasalization of sphenoid sinus on recurrence rate of allergic fungal sinusitis Recurrence will be evaluated by clinical endoscopic evaluationof regular endoscopic examination first visit after one week,the second after 3 weeks and after 3month. CT nose and paranasal sinus will be done after 3 and 6 months.

次要结局

  • Type of caustive organism(2weeks)

研究者

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

hoda abdelkader mohamed

ENTspechilist

Assiut University

研究点 (2)

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