A non randomized control trial study on surgical and post operative outcomes of bipolar electro cautery versus combined cold knife and cautery tonsillectomy in RIMS, Imphal
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Independent Variables-
研究概览
简要总结
Tonsillectomy remains to be an ordinary operative procedure in otorhinolaryngology. Although there are a plenty of surgical means adopting in otorhinolaryngology, the advantage of one method over another has not been systematically demonstrated. The aim of designing this study is to evaluate the outcomes of bipolar electrocautery tonsillectomy compare with combined cold knife cautery tonsillectomy.
A total of 40 patients aged 12 to 40 years of either sex, who are admitted in the otorhinolaryngology ward with one or more indications of tonsillectomy will be divided into two groups (Group 1 and Group 2) non randomly. In group 1 patients will receive Bipolar electrocautery tonsillectomy and group 2 will receive combined cold knife cautery tonsillectomy. The parameters to be measured are Intra-operative time in minutes, intra-operative blood loss in milliliter, post-operative discomfort or Pain in visual analogue pain and post-operative secondary hemorrhage. The data collected will then be analyzed and interpreted by appropriate statistical method.
The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients aged between 12-40 years with one or more of the followings 1.Hypertrophied tonsils causing obstructive sleep apnoea, cor-pulmonale, alveolar hypoventilation and dysphasia 2.Haemorrhagic tonsillitis 3.Tonsillitis causing febrile seizures 4.Recurrent tonsillitis 5.Chronis tonsillitis refractory to antimicrobial therapy 6.Peritonsillar abscess.
排除标准
- •1.Children suffering from tonsillitis of age less than 12 years 2.Patient requiring adenoidectomy 3.Underlying bleeding and clotting disorders 4.Pregnancy and lactation 5.Sub-mucous cleft palate 6.Chronic systemic illness 7.Suspected malignancy.
结局指标
主要结局
Independent Variables-
时间窗: From starting of the operative procedure to 1 month post operative period
1. Age
时间窗: From starting of the operative procedure to 1 month post operative period
2. Sex
时间窗: From starting of the operative procedure to 1 month post operative period
3. Age of onset
时间窗: From starting of the operative procedure to 1 month post operative period
4. Duration of illness for which tonsillectomy is indicated
时间窗: From starting of the operative procedure to 1 month post operative period
Dependent Variable-
时间窗: From starting of the operative procedure to 1 month post operative period
1.Intra operative time in minutes
时间窗: From starting of the operative procedure to 1 month post operative period
2.Amount of intra operative blood loss in millilitre
时间窗: From starting of the operative procedure to 1 month post operative period
3.Post-operative discomfort or pain in visual analogue pain scale
时间窗: From starting of the operative procedure to 1 month post operative period
4.Post-operative secondary hemorrhage
时间窗: From starting of the operative procedure to 1 month post operative period
次要结局
未报告次要终点
研究者
Subham Debnath
Regional Institute Of Medical Sciences
