A Study Comparing the outcomes of Graft Placement Medial and Lateral to the Handle of Malleus in Type 1 Tympanoplasty Underlay Technique.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the graft uptake rate in both techniques
研究概览
简要总结
The study "a study comparing the outcomes of graft placement medial and lateral to the handle of malleus in type 1 tympanoplasty underlay technique" will be conducted in the department of otorhinolaryngology, varun arjun medical college, and rohilkhand hospital, banthra, shahjahanpur, uttar pradesh.
a. study setting and participants
the research focuses on patients with tympanic membrane perforations due to chronic otitis media (com) of the mucosal type, attending the ent outpatient clinic of the aforementioned institution. the inclusion and exclusion criteria ensure that eligible participants are between 12 and 60 years old, present isolated conductive hearing loss, and exhibit inactive com with specific tympanic perforations. patients with recurrent com, ossicular disruption, or uncontrolled systemic conditions are excluded.
b. objectives
-
evaluate graft uptake success rates for medial versus lateral placement of temporalis fascia.
-
compare hearing improvement post-surgery.
-
assess complications associated with each grafting technique.
c. methodology
design: prospective randomized controlled trial.
duration: april 2024 to september 2025.
sample size: 40 patients (20 per group), randomly assigned to either medial or lateral graft placement groups.
procedures: all patients undergo type 1 tympanoplasty using a postaural approach with temporalis fascia grafting, followed by consistent follow-ups (up to six months post-surgery).
outcome measures: graft uptake, improvement in air-bone gap via pure tone audiometry, and incidence of post-op complications.
d. data analysis
spss software will be used to analyze categorical and quantitative variables. statistical significance is determined at a p-value < 0.05.
e. significance
the findings aim to guide surgeons in optimizing graft placement for better hearing outcomes and reduced complications in patients with com.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient admitted and willing for procedure Patients with inactive chronic otitis media tubotympanic disease.
- •Patients with isolated conductive hearing loss with an Air bone gap of less than 45dB.
- •Dry ear for atleast 6 weeks Small or medium sized central perforation in tympanic membrane.
排除标准
- •Patients with recurrent chronic otitis media after previous surgery.
- •Patient with ossicular disruption.
- •Patients with complications of chronic otitis media.
- •Patients with uncontrolled co-morbidities like diabetes mellitus, systemic hypertension, and Bronchial asthma, tuberculosis.
结局指标
主要结局
To determine the graft uptake rate in both techniques
时间窗: 1 year
次要结局
- To compare the hearing improvement in both techniques.(1 year)
研究者
Dr KRITIKA AGRAWAL
Varun Arjun Medical College and Rohilkhand Hospital