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临床试验/NCT06668844
NCT06668844尚未招募不适用

Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).

Assiut University0 个研究点目标入组 68 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
68
主要终点
Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy.

研究概览

简要总结

Patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group A will have endoscopic directDraf IIa frontal sinusotomy and group B will have endoscopic angled Draf IIa frontal sinusotomy, the two groups will be compared according to ostium patency and perioperative morbidity

详细描述

Frontal sinus surgery is a challenging component of endoscopic sinus surgery due to the intricacy and variability of frontal recess and sinus anatomy. Before the introduction of endoscopy in sinus surgery, complex cases of the frontal sinus were managed through the anterior wall using an osteoplastic flap approach. This technique was relatively successful in treating frontal sinus pathologies, but was invasive with adverse effects and failure in 6-25 percent of patients.

Different endoscopic techniques have been introduced for performing frontal sinusotomy. Draf categorized them into four techniques (Draf I, Draf IIa, Draf IIb, Draf III). Draf II procedures widen the frontal sinus outflow tract from the lamina papyracea laterally to the middle turbinate (Draf IIa) or the nasal septum medially (Draf IIb).

The thickness of the nasofrontal beak, and a limited anterior-posterior dimension of the frontal recess, make the Draf IIa frontal sinus surgery with angled endoscopy and instrumentation visually diffcult and requires skilled dexterity.

The direct access or Carolyn's window approach to the frontal recess replicates Draf's technique via the endoscopic approach. The approach utilizes only the 0° endoscope. In this approach, the entire frontal process of the maxilla, agger nasi and nasal process of the frontal bone, is removed with a high-speed drill.The goal of the approach is to visualize all walls of the frontal sinus via a ° endoscope. This postoperative view predicts better irrigation access and drainage of the frontal sinuses.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients (aged 18 and above) with chronic rhino sinusitis affecting the frontal sinus with or without nasal polyps confirmed by nasal endoscopy and CT scan.
  • •Unilateral or bilateral cases.
  • •Denovo or recurrent cases.

排除标准

  • •Individuals younger than 18 year-old.

研究组 & 干预措施

First arm

Experimental

Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy

干预措施: Endoscopic direct Draf IIa (Procedure)

Second arm

Active Comparator

Endoscopic angled Draf IIa frontal sinuaotomy

干预措施: Endoscopic angled Draf IIa (Procedure)

结局指标

主要结局

Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy.

时间窗: 2 years

Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy assessment will be done radiologically after 6 months : it will be considered patent if ostium more than 5mm

次要结局

  • Assess perioperative morbidity of endoscopic direct Draf IIa approach compared to endoscopic Draf IIa frontal sinusotomy with an angled endoscope and instrumentation(2 years)

研究者

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

Hazem Gamal Noreldein

Assistant Lecturer

Assiut University

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