“EFFECTS OF MIDDLE EAR GEL FOAM ON OUTCOMES AFTER TYPE I TYMPANOPLASTYâ€
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Toassessthegraftuptakeandhearing following type 1 tympanoplasty with and without gelfoam packing in the middle ear.
研究概览
简要总结
This prospective randomized case-control study was performed to compare the surgical outcomes of tympanoplasty with or without gel foam packing in the middle ear in patients with chronic otitis media (COM), according to the surgical procedure.
Following preoperative evaluation, the patients are taken up for Type 1 tympanoplasty by postaural approach. Packing of the middle ear is performed based on the group to which the patient belongs.
· Group A: packing of middle ear done with Gel foam.
· Group B: middle ear not packed.with gel foam
The patient’s ear is then monitored at regular intervals for signs of graft failure and infections. Assesment with Pure tone audiometry and Impedence is performed at 12 weeks post surgery. .These datas will be compiled and will be used for publications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with central perforation in tympanic membrane who require Type I Tympanoplasty.
排除标准
- •Patient below 18 or above 70 years of age Patients who requires ossiculoplasty.
- •Patients currently having ear discharge.
- •Patients with history of previous surgery to ear Unsafe Ear pathology, SNHL/mixed hearing loss.
- •Patient with cleft palate.
结局指标
主要结局
Toassessthegraftuptakeandhearing following type 1 tympanoplasty with and without gelfoam packing in the middle ear.
时间窗: 12 weeks.
次要结局
- To evaluate and compare the complications in both techniques(MONITORING TWICE IN 12 WEEKS TIME POINT)