Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- NOSE score
研究概览
简要总结
The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
only one surgeon did the surgeries, other two assessors didnt know which intervention was done, the patient didn't know which group did they belong to
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with the following criteria were eligible for inclusion:
- •Age group: 18-60 years old.
- •Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
- •Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.
- •Patients who are unfit for general anesthesia
排除标准
- •All Patients with:
- •Marked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study
结局指标
主要结局
NOSE score
时间窗: 1 year
nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention
Pain VAS score
时间窗: 1-3 months postoperative
patient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain
Turbinate Size grading
时间窗: 1 year postoperative
endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity
次要结局
未报告次要终点
研究者
Ibrahim M. Gehad
Dr. Ibrahim Gehad
Kafrelsheikh University