Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- closure of tympanic membrane perforation
研究概览
简要总结
Eligible participants with chronic tympanic membrane perforation (>6 month) will be given a detailed description and offered to participate in the study.
the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic tympanic membrane perforation (>6 months).
- •Central tympanic membrane perforation.
- •Air bone gar of 35 dB or lower at the operated ear.
- •No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.
- •No evidence of a retraction pocket and no suspicion for a cholesteatoma.
排除标准
- •Known ossicular chain dysfunction
- •The tympanic membrane perforation edges are not accessible/visualized transcanal
- •Pregnancy
- •Allergy to lidocaine
研究组 & 干预措施
Transcanal tympanoplasty under local anasthesia with fat graft and "Tachosil"
eligibale participatns with chronic tympanic membrane perforation will be offered to participate.
Under local anesthesia, subcutaneous fat from the neck will be harvested. After that trimming of the perforation edges, planting the fat graft medial to the tympanic membrane and placement of the "Tachosil" on top of the fat graft.
gelfoam is placed lateral to the tympanic membrane fo fill the ear canal. follow-up will be held at 2, 4-6 and 12 month following the procedure, with audiometric and otological evaluation
干预措施: Tympanoplasty performed under local anesthesia using fat graft and "Tachosil". (Procedure)
结局指标
主要结局
closure of tympanic membrane perforation
时间窗: 1 year following the procedure
the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.
次要结局
- Hearing results following tympanoplasty - Pure Tone Average(1 year following the procedure)
- Hearing results following tympanoplasty - Speech recognition threshold(1 year following the procedure)
- Hearing results following tympanoplasty - air bone gap.(1 year following the procedure)
研究者
Yoni Evgeni Gutkovich
Doctor
HaEmek Medical Center, Israel