Suction Diathermy Adenoidectomy : Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the efficacy of suction diathermy in completeness of adenoid removal
研究概览
简要总结
The aim of this prospective study is to evaluate the efficacy and safety of endoscopic suction diathermy adenoidectomy as regard the operative time, adenoid tissue remnant, blood loss, and clinical events like pain, halitosis, postoperative hemorrhage, speech changes and recurrence.
详细描述
Suction diathermy adenoidectomy is a procedure that uses thermal energy generated by electric current to ablate adenoid which is removed using suction. This procedure was described in 1997 and the technique has the advantage of complete tissue removal with reduced blood loss and intraoperative time, also reduced post-operative complications as postoperative hemorrhage , nasality and lower recurrence rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive symptoms such as long-lasting nocturnal snoring, sleep apnea, and open mouth breathing, bilateral nasal obstruction, and/or bilateral nasal discharge.
- •Adenoid hypertrophy is the only cause of nasal obstruction.
- •Radiography evidence of adenoid hypertrophy encroaching on the airway column.
- •Age under 15 years.
- •Sex: both males and females.
- •All patients are generally well and fit for surgery.
排除标准
- •Presence of chronic diseases such as chronic heart diseases, chronic liver diseases, chronic renal diseases, and diabetes mellitus.
- •Patients with other causes of nasal obstruction such as acute rhinitis, allergic rhinitis, septal deviation, inferior turbinate hypertrophy, antrochoanal polyp, nasal polypi or anatomical deformities (Choanal atresia).
- •Cases with submucous cleft palate and cases with a previous history of cleft palate repair.
- •Patients with bleeding or coagulation defects.
- •Patients with atrophic rhinitis.
- •Patients with recurrent adenoid.
结局指标
主要结局
the efficacy of suction diathermy in completeness of adenoid removal
时间窗: intraoperative
Flexible fibre optic nasopharyngoscope or zero degree nasal endoscope is used for evaluation of the nasopharynx and determine the adenoid remnant in percentage.
amount of intraoperative blood loss with suction diathermy adenoidectomy
时间窗: intraoperative
amount of blood loss measured in cubic centimeter
postoperative hemorrhage
时间窗: 2 weeks
percentage of occurence of post operative hemorrhage
Recurrence of symptoms
时间窗: 6 months
Flexible fibre optic nasopharyngoscope or 0 degree nasal endoscope is used for evaluation of the nasopharynx to detect any remnant or recurrence of adenoid in percentage
次要结局
- Intraoperative trauma to adjacent structures with suction diathermy adenoidectomy(6 months)
- postoperative halitosis(7 days)
- operative time with suction diathermy adenoidectomy(6 months)
- Postoperative pain(7 days)
- Speech changes(6 months)
研究者
Amr Hamed Hashem
principal investigator
Sohag University