Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean Hearing Gain (Closure in Air-Bone Gap)
研究概览
简要总结
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss. When such perforations do not heal on their own, surgery called tympanoplasty is performed to repair the eardrum and improve hearing.
There are different surgical techniques for tympanoplasty. In the underlay technique, the graft (a small piece of tissue used to repair the hole) is placed beneath the layers of the eardrum. This approach is simpler and commonly used, but it carries risks such as displacement of the graft. In the interlay technique, the graft is positioned between specific layers of the eardrum, which may allow more natural healing and better hearing results, but it is technically more demanding.
This clinical study will compare the postoperative outcomes of these two techniques-interlay and underlay-among adults with large central perforations of the eardrum caused by chronic otitis media. The main outcomes assessed will include hearing improvement (measured by closure of the air-bone gap on hearing tests).
We hypothesize that the placement of the graft significantly influences surgical success and hearing recovery. By comparing interlay versus underlay techniques, the study aims to identify which method provides better results for patients. The findings may help refine surgical approaches and improve the overall quality of life for individuals undergoing tympanoplasty.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged l6-60 years, of any gender.
- •individuals with chronic otitis media characterized by inactive mucosal disease (absence of discharge) accompanied by a large central perforation persisting for at least 6 weeks and exhibiting pure conductive hearing loss as established through pure-tone audiometry.
排除标准
- •Presence of active otitis media manifesting acute infection or discharge.
- •Patients diagnosed with tympanosclerosis or ossicular necrosis, adversely affecting ossicular chain mobility, as identified in preoperative assessments.
- •History of ear surgeries, excluding myringotomy, that could potentially impact tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy.
- •Individuals with sensorineural or mixed hearing loss, as determined by pure-tone audiometry, indicating a possible alternate or additional source of hearing impairment.
- •Conditions potentially hindering wound healing or compliance with postoperative care, including but not limited to uncontrolled diabetes mellitus or immunodeficiency disorders.
- •Patients exhibiting eustachian tube dysfunction, as confirmed through clinical evaluation or medical records.
- •Patients with an active focus of infection in the throat, nose, paranasal sinuses, or oral cavity, as determined by medical records.
结局指标
主要结局
Mean Hearing Gain (Closure in Air-Bone Gap)
时间窗: 3 months after surgery
The average improvement in hearing thresholds, measured by pure-tone audiometry at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. The outcome will be assessed by calculating the difference between the preoperative and postoperative air-bone gap (ABG) values in decibels (dB). This measure evaluates the effectiveness of tympanoplasty in restoring conductive hearing loss.
次要结局
未报告次要终点
研究者
Muhammad Israr
Principal Investigator
Shaikh Zayed Hospital, Lahore