Endoscopic Single Flap versus Double Flap Tympanoplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Graft uptake rate at 3 months after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.
研究概览
简要总结
Background and objectives: This study is aimed to compare the outcomes of the two techniques (endoscopic single flap tympanoplasty- ESFT versus endoscopic double flap tympanoplasty - EDFT) of endoscopic tympanoplasty for repairing large tympanic membrane (TM)perforations with limited anterior remnant.
Subjects and methods: In this randomised controlled trial, forty patients with large sized TM perforations were included and randomised in the ESFT and EDFT arms with twenty patients in each group. The ESFT group underwent conventional endoscopic transcanal tympanoplasty using temporalis fascia while the EDFT group underwent the double flap technique of endoscopic transcanal tympanoplasty with an additional anterior flap, outcomes were compared.
Results: Graft success rate was 85% (17/20 cases) in the ESFT group and 90%(18/20 cases) in the EDFT group. The ABG improvement median with interquartile range(IQR) was 5 dB (3.12 dB-10 dB) in the ESFT group and 8.75 dB (5dB-11.87 dB) in the EDFT group. The difference was not statistically significant.
Conclusions: When EDFT versus ESFT was attempted endoscopically in our study, there was no statistically significant difference in the graft success rate or hearing gain. Moreover, there was longer operative time and need for an extra incision while raising the anterior flap. This lack of statistically significant results in our study may be since the study has a very small sample size. Whether the same conclusion is reproducible needs to be further explored by a large size randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group >18 years & ≤ 60 years 2.Grade III and Grade IV tympanic membrane perforations.
- •3.Dry ear 4.Good cochlear reserve.
排除标准
- •1.Active mucosal disease 2.Atticoantral disease 3.Revision ear surgery 4.Active nasopharynx or sinus infection 5.Extensive tympanosclerosis 6.Suspected ossicular involvement.
结局指标
主要结局
Graft uptake rate at 3 months after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.
时间窗: 3 months after the intervention (surgery)
次要结局
- Change in air conduction- bone conduction gap (AB gap) after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.(3 months after the intervention(surgery))