Role of Hyaluronic Acid in Type I Tympanoplasty for Total and Subtotal Tympanic Membrane Perforations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Graft success
研究概览
简要总结
Aim: the aim of the study is to compare the results of tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia graft with tympanoplasty using temporalis fascia graft.
Study Design: A prospective single blinded randomized controlled trial that will be carried out on 60 cases with total tympanic membrane perforation who will undergo tympanoplasty at our tertiary referral center. All involved cases will have grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation.
The patients will be randomly divided into 2 groups A and B. Patients in group A will undergo underlay tympanoplasty using temporalis fascia graft with the utilization of hyaluronic acid gel was used as an adjunct to temporalis fascia graft. Patients in group B will undergo classic underlay tympanoplasty using temporalis fascia graft.
The two group will be compared as regards:
- Graft success rate.
- Hearing outcome
- Surgical complications
详细描述
Aim: the aim of the study is to compare the results of tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia graft with tympanoplasty using temporalis fascia graft.
Study Design: A prospective single blinded randomized controlled trial that will be carried out on 60 cases with total tympanic membrane perforation who will undergo tympanoplasty at our tertiary referral center. Prior to study conduction, institutional ethics committee approval was obtained (code: MS.19.04.576). Informed written consents well be obtained from all cases before surgeries.
All involved cases will have grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation where the perforation was total perforation involving the entire four quadrants of the tympanic membrane. All the cases will have inactive dry ear for at least 2 months prior to surgeries. All involved cases will be ≥18 years old. Excluded cases include revision cases, cases with active (discharging ear), cases < 18 years old, immunocompromised cases and cases who missed to follow up.
The patients will be randomly divided into 2 groups A and B using computer generated block randomization. Patients in group A will undergo underlay tympanoplasty using temporalis fascia graft through postauricular approach with the utilization of hyaluronic acid gel was used as an adjunct to temporalis fascia graft. Patients in group B will undergo classic underlay tympanoplasty using temporalis fascia graft through postauricular approach.
The two group will be compared as regards:
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
- •Grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation.
- •Inactive dry ear for at least 2 months prior to surgeries.
排除标准
- •Revision cases.
- •Cases who missed to follow up.
- •Cases with active (discharging) ear.
- •Immunocompromised cases.
研究组 & 干预措施
Tympanoplasty using temporalis fascia
干预措施: Tympanoplasty using temporalis fascia (Procedure)
Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia
干预措施: Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia (Procedure)
结局指标
主要结局
Graft success
时间窗: 6 months
Prescence of an intact non-retracted tympanic membrane
次要结局
- Hearing improvement(6 months)
研究者
Ahmed Hemdan
Assistant Professor of Otorhinolaryngology
Mansoura University