| CTRI Number |
CTRI/2025/10/096701 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare coblator (new) and dissection-snare (old) methods for blood loss in tonsillectomy |
|
Scientific Title of Study
|
Randomized controlled study to compare coblator and dissection-snare methods for blood loss in 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 |
Aniruddh Sinha |
| Designation |
Junior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
403,Tower 10 , Blue Ridge Housing Society , Hinjewadi Phase 1 , Pune
Dhankawadi, Pune-Satara Road
Pune - 411043
Pune
MAHARASHTRA
411057
India |
| Phone |
9028979678 |
| Fax |
|
| Email |
sinhaaniruddh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aniruddh Sinha |
| Designation |
Junior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
403,Tower 10 , Blue Ridge Housing Society , Hinjewadi Phase 1 , Pune
Dhankawadi, Pune-Satara Road
Pune - 411043
Pune
MAHARASHTRA
411057
India |
| Phone |
9028979678 |
| Fax |
|
| Email |
sinhaaniruddh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aniruddh Sinha |
| Designation |
Junior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
403,Tower 10 , Blue Ridge Housing Society , Hinjewadi Phase 1 , Pune
Dhankawadi, Pune-Satara Road
Pune - 411043
Pune
MAHARASHTRA
411057
India |
| Phone |
9028979678 |
| Fax |
|
| Email |
sinhaaniruddh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be) University
Bharati Hospital and Research Centre , Pune - Satara road , Dhankawadi , Pune - 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth (Deemed to be) University |
| Address |
Bharati Hospital and Research Centre , Pune - Satara road , Dhankawadi , Pune - 411043 |
| Type of Sponsor |
Private 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 |
| Dr Aniruddh Sinha |
Bharati Hospital and Research Center |
Bharati Vidyapeeth University , Pune-Satara Road , Pune - 411043
Pune
MAHARASHTRA |
9028979678
sinhaaniruddh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Medical college - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J353||Hypertrophy of tonsils with hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COBLATOR |
Surgical instrument used to dissect soft tissue , in this case tonsils |
| Intervention |
Dissection-Snare |
Instrument used traditionally to remove tonsils
Mollisons Tonsillar Dissector and Eves Tonsillar Snare |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
All patients coming to ENT OPD having chronic tonsillitis and Adenoid Hypertrophy |
|
| ExclusionCriteria |
| Details |
Acute infections
Adenoid hypertrophy
Coagulopathy
Cervical spine pathology
Anti-coagulant therapy
Immunodeficient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intra-operative blood loss |
During the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Surgical time
Postoperative pain
Tonsillar fossa recovery |
6hours,1day,7day
Upto 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/11/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sinhaaniruddh@gmail.com].
- For how long will this data be available start date provided 11-11-2024 and end date provided 27-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
All patients with Chronic tonsillitis will be included in this trial and divided into two groups depending on randomization , intervention - dissection and snare and comparer - coblator . They will be assessed on intra-operative blood loss (primarily) , surgical time , post-operative pain and tonsillar fossa recovery (secondarily). Depending on the findings results will be analysed and the trial will come to a conclusion about the comparison of two surgical method/techniques used for tonsillectomy |