| CTRI Number |
CTRI/2024/08/072797 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparative study on surgical and post operative outcomes of two different methods of tonsillectomy |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subham Debnath |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute Of Medical Sciences |
| Address |
Department Of ENT, Regional Institute Of Medical Sciences, IMPHAL,MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
7005277915 |
| Fax |
|
| Email |
subhamdebnath08828@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
H Priyoshakhi Devi |
| Designation |
Professor and Guide |
| Affiliation |
Regional Institute Of Medical Sciences |
| Address |
Department Of ENT, Regional Institute Of Medical Sciences, IMPHAL,MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
9436034546 |
| Fax |
|
| Email |
hemampriyoshakhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
H Priyoshakhi Devi |
| Designation |
PROFESSOR AND GUIDE |
| Affiliation |
Regional Institute Of Medical Sciences |
| Address |
Department Of ENT, Regional Institute Of Medical Sciences, IMPHAL,MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
9436034546 |
| Fax |
|
| Email |
hemampriyoshakhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ENT, RIMS, IMPHAL, India, pin code 795004 |
|
|
Primary Sponsor
|
| Name |
Subham Debnath |
| Address |
DEPARTMENT OF ENT,RIMS,IMPHAL,INDIA PINCODE 795004 |
| Type of Sponsor |
Other [Post Graduate Trainee] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subham Debnath |
Regional Institute Of Medical Sciences |
RIMS OT Complex room no 7, Department Of ENT
Imphal West
MANIPUR |
7005277915
subhamdebnath08828@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bipolar cautery tonsillectomy.
One patient will undergo only one type of tonsillectomy for both the tonsils. Study findings will be collected from the beginning of operative procedure to 30days post operative period. |
Bipolar electrocautery tonsillectomy, the mucosa of the anterior palatal arch is incised, and tonsillar capsule identified. Using a bipolar electrocautery, tonsils were dissected from superior to inferior pole. Care was taken to remain close to cleavage within its capsule. Study findings will be collected from the beginning of operative procedure to 30days post operative period. |
| Comparator Agent |
COMBINED COLD KNIFE AND CAUTERY TONSILLECTOMY |
Combined cold knife cautery tonsillectomy, the upper pole of
the tonsil was grasped with a tonsil holding forceps and pulled medially. Using a no 12 surgical blade mucosa of the anterior palatal arch incised and the loose areolar tissue plane between tonsillar capsule and tonsillar bed is identified by gently pushing the upper pole of tonsil medially with tonsil retractor. Further blunt dissection was carried out towards the lower pole of the tonsil. During dissection any bleeding points found were quickly cauterized for 2-3 seconds with a bipolar diathermy forceps with a power setting of 26 watts and packed with cotton balls. The cautery point was carefully applied close to the tonsil. The bleeding points found in the tonsillar bed were also cauterized in the same way.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Independent Variables-
1. Age
2. Sex
3. Age of onset
4. Duration of illness for which tonsillectomy is indicated
Dependent Variable-
1.Intra operative time in minutes
2.Amount of intra operative blood loss in millilitre
3.Post-operative discomfort or pain in visual analogue pain scale
4.Post-operative secondary hemorrhage
|
From starting of the operative procedure to 1 month post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |