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CTRI Number  CTRI/2025/12/099301 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STUDY TO COMPARE COBLATOR(new) AND MICRODEBRIDER (old) METHODS FOR INTENSITY OF POSTOPERATIVE PAIN IN ADENOIDECTOMY 
Scientific Title of Study   Randomised controlled study to compare coblator and microdebrider methods for intensity of postoperative pain in Adenoidectomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Somya Maskara 
Designation  Junior resident 
Affiliation  Bharati Hospital and research Centre  
Address  204, C wing, Staff Quarters Bharati Vidyapeeth Campus,Dhankawadi Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  7543806008  
Fax    
Email  Somya.maskara@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Somya Maskara 
Designation  Junior resident 
Affiliation  Bharati Vidyapeeth Hospital and Research Centre 
Address  204, C wing, Staff Quarters Bharati Vidyapeeth Campus, Dhankawadi Pune- 411043
Good Books, Main Road Begusarai, Bihar 851101

MAHARASHTRA
411043
India 
Phone  7543806008  
Fax    
Email  Somya.maskara@gmail.com  
 
Details of Contact Person
Public Query  
Name  Somya Maskara 
Designation  Junior resident 
Affiliation  Bharati Hospital and Research Centre 
Address  204, C wing, Staff quarters Bharati Vidyapeeth Campus, Dhankawadi Pune 411043
Good Books, Main Road Begusarai Bihar- 851101

MAHARASHTRA
411043
India 
Phone  7543806008  
Fax    
Email  Somya.maskara@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth(Deemed to be)University Bharati Hospital and Research Centre, Dhankawadi, Pune-411043 Maharashtra, India 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed to be University 
Address  Bharati Vidyapeeth Deemed to be University Dhankawadi, Pune- 411043 Maharashtra, India Pune 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Somya Maskara  Bharati Hospital and Rersearch Centre  Department of ENT AND HEAD AND NECK Surgery Bharati Vidyapeeth Hospital and Research Centre, Dhankawadi, Pune -411043 Division-1 Dhankawadi Pune
Pune
MAHARASHTRA 		 7543806008

Somya.maskara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth deemed to be university INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Symptomatic Adenoid hypertrophy 
 
ExclusionCriteria 
Details  Presence of active infection
Bleeding and clotting disorder
Overt or submucous cleft palate 
 
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 
To compare postoperative pain intensity by VAS in microdebrider and coblation methods for adenoidectomy  To compare postoperative pain intensity by VAS in microdebrider and coblation methods for adenoidectomy
1)6 hours after the surgery
2)24 hours after the surgery
3) 7 days after the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare intraoperative blood loss in microdebrider and coblation method for adenoidectomy
2.To compare surgical time in microdebrider and coblation method for adenoidectomy

3.To compare postoperative hemorrhage in microdebrider and coblation methods for adenoidectomy 		 1. Intraoperative
2.Surgical time
3postoperative hemorrhage will be calculated 6 hours after surgery,on day 1 and day 7 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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)   31/12/2025 
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="5"
Days="29" 
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
  1. 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).

  2. 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Somya.maskara@gmail.com].

  6. For how long will this data be available start date provided 26-12-2025 and end date provided 26-10-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Institutional ethical committee clearance is obtained, consent/assent will be taken.the care givers of the patients in case of children whereas in adults the patients will be explained about the randomised controlled trial in detail, willingness is there to enter the trial they will randomly be allowed into either group A (coblation) and group  B (Microdebrider) by computer generated number, allocation concealment will be done using opaque sealed envelopes. Only outcome measurer will be blinded. Preoperative clinical and laboratory evaluation will be done and patients with active infection, bleeding disorder will be excluded. Intra-operative findings like surgical time, intraoperative blood loss will be recorded by the nurse/MPW, along with Post-operative findings like postoperative pain will be recorded by the team who were not a part of the OT. 
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