Evaluation of Prognostic Factors and Middle Ear Risk Index in Tympanoplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done.
研究概览
简要总结
Tympanoplasty is the surgical operation performed for the reconstruction of the eardrum and/or the ossicles. Tympanoplasty is classified into five different types, originally described by Horst Ludwig Wullstein. 1,2 Type 1 involves repair of the tympanic membrane alone, when the middle ear is normal. A type 1 tympanoplasty is synonymous to myringoplasty, Type 2 involves repair of the tympanic membrane and middle ear in spite of slight defects in the middle ear ossicles, Type 3 when mallus and incus are absent graft place directly on stapes head., Type 4 describes a repair when the stapes foot plate is movable, but the crura are missing. The resulting middle ear will only consist of the Eustachian tube and hypotympanum, Type 5 is a repair involving a fixed stapes footplate.
There are various prognostic factors reported in the literature that may influence the surgical success of tympanoplasty.
详细描述
Some studies report significance for some of these factors whereas others report the contrary. The reported incidence of surgical success of tympanoplasty ranges from 60% to 99% in adults Belluci described four separate stages for prognosis of tympanoplasty 4 according to otorrhea
. Austin proposed a prognostic stratification according to disease categories, stage categories, and disease descriptors.
Black introduced the surgical, prosthetic, infection, tissues, and eustachian tube system (SPITE), and more recently Kartush developed middle ear risk index (MERI).
Smoking is added as a middle ear risk. Furthermore, cholesteatoma and granulation tissue or effusion risk value has been increased in MERI 2001.
Prognostic factors such as age, sex, presence of systemic diseases, location and size of perforation, duration of dry period, presence of myringosclerosis, presence of septal and conchal pathology, operation type, and status of the opposite ear and middle ear risk index were investigated. 9
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty.
排除标准
- •Patients with otomycosis, septic foci such as sinusitis which can influence the outcome of tympanoplasty were excluded from the study
结局指标
主要结局
Evaluation of prognostic factors in tympanoplasty to predict the outcome of the surgical management whenever done.
时间窗: One year
Prognostic factors such as age, sex, presence of systemic diseases, location and size of perforation, duration of dry period, presence of myringosclerosis, presence of septal and conchal pathology and status of the opposite ear and middle ear risk index will be investigated.
Evaluation of middle ear risk index in tympanoplasty
时间窗: One year
Each risk parameter will take a numerical value; Ear discharge: 0-3, Perforation: 0-2, Cholesteotoma: 0-2, Ossicular chain status: 0-4, Middle ear granulation and history of previous surgery: 0-2. Now newly, smoking is also included as a risk parameter. The MERI will be evaluated. The patients will be categorized into those with mild (0-3), moderate(4-6) and severe(≥7) MERI
次要结局
未报告次要终点
研究者
asmaa.nabil
Principal investigator
Assiut University