Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)
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
- 否
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
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
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
Enas Saad Khalil
Resident
Assiut University
