To compare outcome between cartilage and temporal fascia grafts in endoscopic type 1 tympanoplasty.(Comparative study)
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The tympanic membrane being intact without retraction or lateralization at 4weeks, 12 weeks and 24 weeks, and the difference between pre op and post op air bone gap (ABG) at 24 weeks
研究概览
简要总结
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. Perforation of the tympanic membrane can result from middle ear infections, trauma or the treatment of middle ear diseases. A tympanoplasty is a surgical procedure to close a tympanic membrane perforation and reconstruct the tympanic membrane and hearing, commonly after chronic otitis media and trauma. A tympanoplasty is fundamentally a tissue transference procedure. Various graft materials have been used to close tympanic membrane perforations. These graft materials include temporalis fascia muscle, cartilage, perichondrium, dura mater, vein tissue, fat, and skin. This study aims to compare the hearing gain and structural stability of cartilage graft and temporalis fascia in patients undergoing endoscopic type 1 tympanoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 17.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients requiring type 1 tympanoplasty.
- •Central perforation.
- •Intact ossicular chain on endoscopic examination.
- •Dry ear for more than 3 months.
- •No mastoid surgery in the past.
- •Minimum follow up of 1 year.
- •Patients with informed consent.
排除标准
- •Affected/ distorted ossicular chain on endoscopic examination.
- •Total and marginal perforation.
- •Revision surgeries.
- •Cholesteatoma and retraction pockets.
- •Patients unwilling to participate in study.
- •Chronic sinusitis allergic rhinitis.
结局指标
主要结局
The tympanic membrane being intact without retraction or lateralization at 4weeks, 12 weeks and 24 weeks, and the difference between pre op and post op air bone gap (ABG) at 24 weeks
时间窗: 24 weeks
次要结局
- NA(NA)
研究者
Rajat Bhardwaj
Dr Rajendra Prasad Medical College Kangra At Tanda