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临床试验/CTRI/2024/08/072797
CTRI/2024/08/072797尚未招募3 期

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

Subham Debnath1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月8日最近更新:

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

发起方
Subham Debnath
申办方类型
Other [Post Graduate Trainee]
责任方
Principal Investigator
主要研究者

Subham Debnath

Regional Institute Of Medical Sciences

研究点 (1)

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