A study on audiological outcome of various ossiculoplasty techniques in the surgical management of chronic otitis media.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- in such patients.
研究概览
简要总结
Chronic suppurative otitis media (CSOM) is a major health care problem mostly presents with discharging ear. In 400 B.C. in Sushruta Samhita it was mentioned as Putikarna (pus in ear)6. According to WHO Chronic suppurative otitis media (CSOM) is defined as a chronic inflammation of the middle ear and mastoid cavity, which presents with recurrent ear discharges or otorrhoea through a tympanic perforation. Prevalence surveys show that the global burden of illness from CSOM involves 65–330 million individuals with draining ears, 60% of whom (39–200 million) suffer from significant hearing impairment.5 This persistent disease is capable of irreversible destruction of middle ear structures and grave complications. The 1993 World Development Report (185) estimated that about 5.12 million disability-adjusted life-years (DALYs) were lost from otitis media, 91% of which comes from the developing world.5 Ossicular chain damage from chronic ear disease is a significant problem in the practice of otorhinolaryngology leading to conductive hearing loss. One of the most intriguing topics in middle ear surgery is the reconstruction of this conductive mechanism. Ossiculoplasty is reconstruction of the ossicular chain which aims to surgically optimize the middle ear transformer mechanism so that sound energy is conducted from the environment to the inner ear fluid with only minimal loss.1. Ever since Matte’s first myringostapediopexy in 1901, there has been a quest for the ideal middle ear implant with the understanding that the middle ear environment in chronic ear disease is probably the main factor in determining treatment success.2 3 Hall and Rytzner (1957) performed the first ossicular reconstruction using autologous incus which has been the most common autograft material and is often reshaped to fit between the manubrium of the malleus and the stapes head4. The Austin classification of ossicular problems is very practical. Due to the wide variability of techniques and implants available today, reconstructions are generally reported without reference to a particular classification and instead include a detailed description of the type of prosthesis used, how it is interposed between the ossicular defect, and the use of other interposed or stabilizing grafting materials1. Ossicular reconstruction is performed in otherwise healthy ears or in conjunction with a tympanoplasty and mastoidectomy for chronic ear disease. Long term success of ossicular reconstruction depends upon five factors- 1. surgery (open versus closed mastoidectomy), 2. prosthesis type, 3. presence of infection, 4. tissue health., and 5. Eustachian tube function. These five factors allow for an accurate preoperative individual assessment when counselling patients regarding the likelihood of success of a proposed ossicular reconstruction7. The purpose of undertaking this study is to evaluate the surgical as well as audiological outcome of various techniques of ossicular chain reconstruction which acts by re-establishment of middle ear mechanics using autologous grafts (autologous incus, malleus, cartilage) carried out in the management of chronic otitis media.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients presenting with chronic otitis media with indications of ossicular reconstruction.
- •Patients with ossicular discontinuity presenting with conductive hearing loss.
排除标准
- •Patients presenting with acute suppurative otitis media, otosclerosis, congenital hearing disorder, sensorineural and mixed hearing loss.
- •Patients with systemic disease and other complications making unfit for surgery.
- •Ear malignancy.
- •Revision surgery.
- •Patients with congenital ear disease.
- •Cases with intact ossicles.
结局指标
主要结局
in such patients.
时间窗: 3 weeks, 6 weeks and 3 months.
To find out the audiological outcome among different types of ossciculoplasty procedures done
时间窗: 3 weeks, 6 weeks and 3 months.
次要结局
- Inspection of the mastoid cavity to determine whether discharge was still present or not & the status of the neo tympanic membrane.(6 weeks & 3 months.)
研究者
Dr Monjita Borthakur
Silchar Medical College and Hospital
