Boomerang-Shaped Cartilage/Perichondrial Graft in Endoscopic Tympanoplasty for Anterior or Subtotal Tympanic Membrane Perforations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Graft Uptake Rate
研究概览
简要总结
This study evaluates the anatomical and functional outcomes of using a boomerang-shaped chondroperichondrial graft in endoscopic Type I tympanoplasty for repairing anterior or subtotal tympanic membrane perforations.
Anterior and subtotal eardrum perforations represent challenging surgical scenarios due to limited visualization, lack of anterior graft support, and higher risks of graft retraction, medialization, or residual perforation. The boomerang-shaped cartilage and perichondrium graft provides a sturdy cartilage framework along the anterior border to secure structural support, while maintaining a thin perichondrial layer over the functional vibratory area to facilitate acoustic transmission.
All enrolled participants undergo endoscopic Type I tympanoplasty using this autologous grafting technique. Follow-up assessments are conducted at 1, 3, and 6 months after surgery to determine successful graft uptake, evaluate hearing improvement (via pure-tone audiometry and air-bone gap closure), and monitor for complications such as blunting, retraction, lateralization, or infection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Anterior or subtotal tympanic membrane perforation
- •Dry ear for at least 3 months prior to surgery
- •Intact and mobile ossicular chain on clinical and intraoperative assessment
- •Aerated middle ear with healthy or near-normal middle ear mucosa
- •No evidence of cholesteatoma
- •Ability to attend all scheduled postoperative follow-up visits
- •Provision of written informed consent
排除标准
- •Active ear discharge at the time of surgery
- •Presence of cholesteatoma
- •Marginal or attic perforation associated with pathology requiring mastoid surgery
- •Ossicular discontinuity or erosion requiring ossiculoplasty
- •Significant adhesive otitis media
- •Previous failed tympanoplasty in the same ear
- •Severe Eustachian tube dysfunction associated with adhesive disease
- •Craniofacial anomalies affecting the ear
- •Uncontrolled systemic disease contraindicating surgery
- •Narrow external auditory canal precluding endoscopic access
- •Inability to complete the planned follow-up period
研究组 & 干预措施
Boomerang-Shaped Chondroperichondrial Graft
Patients undergo endoscopic Type I tympanoplasty using an autologous boomerang-shaped chondroperichondrial graft for the repair of anterior or subtotal tympanic membrane perforations. Graft uptake, audiometric outcomes (pure-tone audiometry thresholds and air-bone gap closure), and postoperative complications are assessed over a 6-month follow-up period.
干预措施: Endoscopic Type I Tympanoplasty with Boomerang-Shaped Chondroperichondrial Graft (Procedure)
结局指标
主要结局
Graft Uptake Rate
时间窗: 6 months postoperatively
Percentage of patients achieving complete anatomical closure and intact healing of the tympanic membrane perforation without residual defect, verified by postoperative otoscopic and endoscopic examination.
次要结局
未报告次要终点
研究者
Reham Asaad Ibrahim Mohamed
Resident
Assiut University