Skip to main content
Clinical Trials/CTRI/2024/08/072797
CTRI/2024/08/072797
Not yet recruiting
Phase 3

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 site in 1 country40 target enrollmentStarted: September 8, 2024Last updated:

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

Sponsor
Subham Debnath
Sponsor Class
Other [Post Graduate Trainee]
Responsible Party
Principal Investigator
Principal Investigator

Subham Debnath

Regional Institute Of Medical Sciences

Study Sites (1)

Loading locations...

Similar Trials