A Comparative Study Between Interlay and Underlay in Type 1 Tympanoplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To analyse and compare the outcomes of interlay and underlay techniques in type 1 tympanoplasty in terms of graft uptake and hearing improvement.
研究概览
简要总结
Chronic suppurative otitis media (CSOM) has a major impact on the social life of a person in the form of hearing disability. The discharge from the ear is also troublesome causing great discomfort to the patient. The mucosal type of CSOM can be treated surgically by tympanoplasty. It is a procedure done to repair the defect in the tympanic membrane after eradicating all the disease in the middle ear cleft with or without reconstruction of ossicular chain . The classification is based on the placement of graft in relation to the remnant tympanic membrane as:
(a) Underlay technique—graft is placed medial to the mucosal layer.
(b) Overlay technique—graft is placed lateral to the ï¬brous layer of tympanic membrane after elevating all squamous epithelium.
(c) Interlay technique—graft is placed between the ï¬brous layer and the endothelial (mucosal) layer of the drum remnant.
In overlay technique there are chances of anterior canal wall blunting, lateralisation of the graft, formation of epithelial pearls, excessive membrane thickness, and longer duration of healing and increased risk of iatrogenic cholesteatoma . The disadvantages of underlay technique are that the middle ear space is reduced, there are chances of medialisation of the graft , less suitable for large anterior perforations and longer healing time.
In interlay technique the graft is supported medially by the mucosal layer and laterally by the ï¬bro squamous layer thus contributing to the following advantages:
a) There is no blunting, as the anterior sulcus is skin lined.
b) Interlay is more physiological and anatomical compared to underlay and overlay
c) No lateralisation, as the graft is placed medial to mallets and ï¬bro-squamous layer.
d) No epithelial cyst formation.
e) No medialisation.
f) Can clear tympanosclerosis from anterosuperior quadrant easily.
g) Myringitis due to endothelium overgrowth on the graft is avoided.
h) No reduction in middle ear space.
The present study is undertaken to evaluate the outcome of type 1 interlay tympanoplasty in comparison to underlay techniques. The objectives are to evaluate the graft take up rate, to compare the hearing improvement and to study the complications associated with interlay technique and underlay technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases of chronic otitis media with inactive mucosal disease with a small to large central perforation and pure conductive hearing loss were included in the study.
- •Active mucosal disease under local and systemic antibiotic coverage for 7 days.
- •Both males and females in the age group of 10 to 60 years of age were included in the study.
排除标准
- •1.Patients with squamosal disease 2.Patients with ossicular discontinuity/ necrosis 3.Patients below 10 years and above 60 years were excluded from the study.
- •4.Patients with active focus of infection in throat, nose and oral cavity 5.Patients who fail to follow-up for at least 3 months.
结局指标
主要结局
To analyse and compare the outcomes of interlay and underlay techniques in type 1 tympanoplasty in terms of graft uptake and hearing improvement.
时间窗: 1 month, 3 months and 6 months after surgery
次要结局
- To find the incidence of CSOM in 10- 60yrs age group(1 yr)
- Expected findings and complications after type 1 tympanoplasty(1 yrs)
- To find out the etiological factors of mucosal type of COM(1 yr)
研究者
Dr Sudip Kumar Nath
Silchar Medical College and Hospital