Prospective study on outcomes of cholesteatoma surgery in a tertiary care center
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine incidence rate of dry ear and disease-free cavity at six months in adult acquired cholesteatoma patients undergoing surgery
研究概览
简要总结
Patients aged 18-65 yrs and all genders diagnosed with acquired cholesteatoma and planned for cholesteatoma surgery will be recruited. Detailed history taking and clinical examination will be done. Patients will undergo Pure Tone Audiometry (PTA) and HRCT Temporal Bone. Surgery as per extent of disease will be performed.
Intraoperatively correlated with radiological findings.
Chronic ear Survey questionairre to be done at preop and at 6 months to compare the quality of life before and after surgery
Follow up on 1 month, 3 month and 6 months for clinical examination to assess for complcations
PTA to be done preoperatively and at 6 months to compare improvement in hearing.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age group 18-65 yrs of all genders diagnosed with acquired cholesteatomatous disease.
- •Patients undergoing primary cholesteatoma surgery.
- •Patients willing to provide written informed consent and comply with follow-up protocol.
排除标准
- •Patients not willing to consent Patients with uncontrolled comorbidities affecting healing and surgical outcomes patients undergoing revision cholesteatoma surgery patients unfit for surgery under GA.
结局指标
主要结局
To determine incidence rate of dry ear and disease-free cavity at six months in adult acquired cholesteatoma patients undergoing surgery
时间窗: To determine incidence rate of dry ear and disease-free cavity at six months in adult acquired cholesteatoma patients undergoing surgery | To compare pre & post surgery hearing outcomes at six months.
To compare pre & post surgery hearing outcomes at six months.
时间窗: To determine incidence rate of dry ear and disease-free cavity at six months in adult acquired cholesteatoma patients undergoing surgery | To compare pre & post surgery hearing outcomes at six months.
次要结局
- To determine radiologic correlation of disease extent with intraoperative findings(to compare the quality of life pre and post surgery using Chronic Ear Survey scale)
研究者
Dr Moumita Barik
Aiims, new delhi