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
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Subham Debnath
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Independent Variables-
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 12.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Independent Variables-
Time Frame: From starting of the operative procedure to 1 month post operative period
1. Age
Time Frame: From starting of the operative procedure to 1 month post operative period
2. Sex
Time Frame: From starting of the operative procedure to 1 month post operative period
3. Age of onset
Time Frame: From starting of the operative procedure to 1 month post operative period
4. Duration of illness for which tonsillectomy is indicated
Time Frame: From starting of the operative procedure to 1 month post operative period
Dependent Variable-
Time Frame: From starting of the operative procedure to 1 month post operative period
1.Intra operative time in minutes
Time Frame: From starting of the operative procedure to 1 month post operative period
2.Amount of intra operative blood loss in millilitre
Time Frame: From starting of the operative procedure to 1 month post operative period
3.Post-operative discomfort or pain in visual analogue pain scale
Time Frame: From starting of the operative procedure to 1 month post operative period
4.Post-operative secondary hemorrhage
Time Frame: From starting of the operative procedure to 1 month post operative period
Secondary Outcomes
No secondary outcomes reported
Investigators
Subham Debnath
Regional Institute Of Medical Sciences