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临床试验/NCT04687995
NCT04687995Unknown不适用

The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study

Assiut University0 个研究点目标入组 40 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty

研究概览

简要总结

  1. Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty.
  2. Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.

详细描述

The exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. Some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. The tragus has a pivotal function in reconstruction in ear surgery. The superficial musculoaponeurotic system (SMAS) was first introduced by Mits and Peyroniein1976. It is located in the mid-face overlying the parotid gland and mimic muscles, It connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. The SMAS graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Above 16 yrs old and less than 50 yrs old.
  • Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic).
  • Dry ear: no otorrhea without medication for at least 1 month.
  • Hearing loss gap not more than 50dB

排除标准

  • Age less than 16 or more than
  • Discharging (active) central perforations.
  • Unsafe CSOM with cholesteatoma.
  • Suspected ossicular pathology in safe CSOM if the gap > 50dB.
  • Previous ear surgery.
  • Patients unfit for surgery or having chronic medical illness.

结局指标

主要结局

comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty

时间窗: Baseline

comparison of results when using tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty success rate by audiological evaluation by using audiotympanogram

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hazem Gamal Noreldein

Resident doctor in otolaryngology

Assiut University

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