A study to evaluate effect after addition of endoscope to microscopic tympanomastoid exploration for chronic otitis media squamous (active)- a randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy
研究概览
简要总结
Background-
The surgical procedure for Chronic Otitis Media Squamous (Active) can either be a canal wall up (CWU) or a canal wall down (CWD) procedure. Both procedures have their advantages and disadvantages. Disease eradication being the primary aim of the surgery, its important to achieve complete clearance of the disease from the middle ear and mastoid. The hidden/ difficult to reach areas include the sinus tympani, deep tip cells, sinodural angle cells and deep supratubal recess. Literature states, intraoperative residual cholesteatoma rates of 13% in CWU mastoidectomy operation and 11.8% in CWD mastoidectomy operation when using microscope.
In contemporary practice, most otologists favour CWU surgery as far as possible in order to preserve normal anatomy alongwith disease clearance. With the advent of modern technology with better illumination, better optics and better magnification this has been possible to a large extent.
Traditionally the otomicroscope has been used for these procedures, however with the advent of endoscopes it has been demonstrated that previously hidden/ difficult areas have become more accessible and it’s the way ahead for these surgeries. The endoscope has been used for grommet insertion, tympanoplasty and few cases of mastoid surgeries. The proponents of endoscope state its advantage of better visualization and better maneuverability in comparison to otomicroscope. However, the exact role of an endoscope in mastoidectomy has not been established.
This study aims to study the effect of addition of endoscope to traditional microscopic surgery in our subset of patients.
Purpose-
Primary Objective - To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy
Secondary Objective- To Evaluate the functional outcomes of in terms of disease progression and audiological outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All consenting patients with Chronic Otitis Media Squamous (active) with involvement of more than 1 site as per STAM CO classification.
排除标准
- •Patients with Chronic Otitis Media Squamous (Inactive) b.
- •Patients with complications of Chronic Otitis Media Squamous c.
- •Patients with posterior canal wall erosion.
结局指标
主要结局
To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy
时间窗: Intraoperative
次要结局
- To evaluate functional outcomes in terms of disease progression and audiological results(3 months)