| CTRI Number |
CTRI/2026/01/102073 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING TWO METHODS OF TONSIL SURGERY (COLD STEEL TONSILLECTOMY WITH COBLATION TONSILLECTOMY) AND THE OUTCOMES SEEN IN THEM LIKE BLEEDING, PAIN AND THE CHANGES WHICH WILL BE SEEN IN THE TISSUE AFTER BEING SENT TO PATHOLOGISTS FOR EXAMINATION |
|
Scientific Title of Study
|
A COMPARISON OF HISTOPATHOLOGICAL FEATURES AND SURGICAL OUTCOMES OF COLD STEEL TONSILLECTOMY VS COBLATION TONSILLECTOMY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nongotonu Koso |
| Designation |
Post graduate resident |
| Affiliation |
ardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Otolaryngorhinology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South Delhi, 110029
India
South
DELHI
110029
India |
| Phone |
8794514886 |
| Fax |
|
| Email |
nongotonukoso@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
ardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Otolaryngorhinology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South Delhi, 110029
India
DELHI
110029
India |
| Phone |
9910050321 |
| Fax |
|
| Email |
guptadeepak74@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nongotonu Koso |
| Designation |
Post graduate resident |
| Affiliation |
ardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Otolaryngorhinology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South Delhi, 110029
India
DELHI
110029
India |
| Phone |
8794514886 |
| Fax |
|
| Email |
nongotonukoso@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdrajung Hospital |
| Address |
Department of Otolaryngorhinology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South Delhi, 110029
India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Nongotonu Koso |
ardhman Mahavir Medical College and Safdarjung Hospital |
Department of Otolaryngorhinology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South Delhi, 110029
India
South
DELHI |
08794514886
nongotonukoso@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
coblation tonsillectomy |
procedure will be done using a coblation machine and coblator wand which will dissect the tonsillar tissue by creating a plasma field using radiofrequency and saline solution |
| Intervention |
cold steel dissection |
procedure will be done by using blunt dissection and tonsillar tissue will be snared using a tonsillar snare |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Indications for tonsillectomy based on SIGN (Scottish Intercollegiate Guidelines Network) |
|
| ExclusionCriteria |
| Details |
1. Patients with acute tonsillitis or peritonsillar abscess
2. History of bleeding diathesis
3. History of immunocompromised status
4. History of known intellectual disability |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of histopathological changes: percentage of skeletal muscle involvement and percentage of mast cell degranulation in tonsillar specimen |
postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative blood loss and operative time in minutes |
Time from surgical incision till achievement of hemostasis |
| Evaluation of postoperative pain and slough grading |
Postoperative day 1, 3 and 7 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomised comparative study which compares the histopathological features and surgical outcomes between cold steel tonsillectomy and coblation tonsillectomy. The primary outcome measure is to compare the percentage of skeletal muscle involvement and percentage of mast cell degranulation in tonsillar specimen following cold steel tonsillectomy and coblation tonsillectomy. The secondary outcome measures will be to compare the intraoperative parameters like blood loss and operative times; evalutaion of post operative pain and slough grading in the two methods of tonsillecomy. |