跳至主要内容
临床试验/NCT07834892
NCT07834892尚未招募不适用

Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)

Assiut University0 个研究点目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Rate of Complete Tympanic Membrane Closure

研究概览

简要总结

Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer of temporalis fascia over the cartilage graft improves anatomical closure and functional hearing.

The primary purpose of this study is to determine whether adding a temporalis fascia layer to a conchal cartilage and perichondrium graft improves graft healing rates and audiological outcomes in patients undergoing tympanoplasty for large or subtotal perforations.

Adult participants with safe chronic suppurative otitis media and large or subtotal tympanic membrane perforations are randomly assigned in a 1:1 ratio to one of two surgical arms:

  • Group A:Tympanoplasty using an autologous conchal cartilage graft with attached perichondrium alone.
  • Group B: Tympanoplasty using an autologous conchal cartilage and perichondrium graft reinforced with an additional outer layer of temporalis fascia placed between the cartilage and the tympanic membrane remnant.

All participants undergo clinical otomicroscopy/otoendoscopy to assess graft take, healing, and complications, alongside pure-tone audiometry (evaluating air-bone gap and hearing thresholds) preoperatively and at 6 months postoperatively.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older
  • Presence of a large or subtotal tympanic membrane perforation
  • Safe chronic suppurative otitis media (CSOM)
  • Undergoing primary or revision tympanoplasty

排除标准

  • Unsafe ear (e.g., presence of cholesteatoma, marginal perforation, or attic pathology)
  • Small or medium-sized tympanic membrane perforations
  • Age younger than 18 years
  • Patients unwilling or unable to attend scheduled postoperative follow-up visits through 6 months

研究组 & 干预措施

Group B: Cartilage, Perichondrium, and Temporalis Fascia

Experimental

Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium combined with an additional temporalis fascia layer placed outside the cartilage graft between the cartilage and the tympanic membrane remnant.

干预措施: Conchal Cartilage, Perichondrium, and Temporalis Fascia Tympanoplasty (Procedure)

Group A: Cartilage and Perichondrium

Active Comparator

Participants undergoing tympanoplasty for large or subtotal tympanic membrane perforations using conchal cartilage with perichondrium graft alone.

干预措施: Conchal Cartilage and Perichondrium Tympanoplasty (Procedure)

结局指标

主要结局

Rate of Complete Tympanic Membrane Closure

时间窗: 6 months postoperatively

Evaluated by otomicroscopic or otoendoscopic examination. Complete closure is defined as an intact graft with total epithelialization and closure of the tympanic membrane perforation, with no residual or recurrent perforation.

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

Enas Saad Khalil

Resident

Assiut University

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