Endoscopic Stapedotomy: Classic Versus Reversal Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Average air conduction pure-tone threshold
研究概览
简要总结
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy.
Patients and Methods
Study design:
This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy.
The two groups will compared to each other as regard, A. Intra-operative time (in minutes) B. Hearing outcome. C. Surgical complications
详细描述
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy.
Patients and Methods
Study design:
This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy.
Inclusion criteria:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of gradual progressive hearing loss with normal otoscopy.
- •No history of ear discharge.
- •No history of ipsilateral ear surgery.
- •Air bone gap >20 dB with lost stapedial reflex
排除标准
- •Cases who did not meet the inclusion criteria.
- •Revision cases.
- •Cases that lost to follow up.
- •All cases with narrow oval window niche or obliterated footplate, because those are the contraindications of reversal technique as described by Fisch (Fisch et al., 1994).
结局指标
主要结局
Average air conduction pure-tone threshold
时间窗: 3 months
The average air conduction pure-tone threshold (in dB HL) will be calculated from pure-tone audiometry and presented in decibels (dB)
Word recognition score
时间窗: 3 months
The word recognition score will be calculated from the the speech audiometry and presented as percentage (%)
Average air bone gap
时间窗: 3 months
Preoperative and postoperative air conduction (AC) and bone conduction (BC) thresholds will be recorded at frequencies of 0.5, 1, 2, and 3 khz. The air-bone gap (ABG) will be recorded as the difference between AC and BC thresholds. Postoperative air bone gap will be graded as grade A (0-10 dB), grade B (11-20 dB), grade C (21-30 dB) and grade D (\>30 dB).
次要结局
未报告次要终点
研究者
Ahmed Hemdan
Lecturer of Otorhinolaryngology
Mansoura University