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CTRI Number  CTRI/2024/11/077303 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between Microdebrider Assisted Adenoidectomy and Coblation Adenoidectomy: Analyzing Post operative Recovery. 
Scientific Title of Study   Endoscopic assisted transoral endonasal adenoidectomy using microdebrider vs coblator : A comparative study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Payal Pandey 
Designation  Post Graduate Trainee 
Affiliation  Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital  
Address  ENT OPD Room no 7 Unit 1 Institute of Otorhinolaryngology and Head Neck Surgery IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  7838549180  
Fax    
Email  payalpandey620@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arunabha Sengupta  
Designation  Professor 
Affiliation  Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital  
Address  ENT OPD HOD Room no 8 Unit 1 Institute of Otorhinolaryngology and Head Neck Surgery IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9831089737  
Fax    
Email  arunabhasengupta2008@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Payal Pandey 
Designation  Post Graduate Trainee 
Affiliation  Institute of Post Graduate Medical Education and Research & Seth Sukhlal Karnani Memorial Hospital  
Address  ENT OPD Room no 7 Unit 1 Institute of Otorhinolaryngology and Head Neck Surgery IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  7838549180  
Fax    
Email  payalpandey620@gmail.com  
 
Source of Monetary or Material Support  
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital 244,AJC Bose Road Kolkata 700020 West Bengal India 
 
Primary Sponsor  
Name  Dr Arunabha Sengupta 
Address  Institute of Otorhinolaryngology and Head Neck Surgery IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata  
Type of Sponsor  Other [(Self)] 
 
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 
Dr Payal Pandey  Institute of Post Graduate Medical Education and Research And SSKM Hospital  ENT OPD Unit 1 Room no 7 (on Wednesday and Saturday) Institute of Otorhinolaryngology and Head Neck Surgery
Kolkata
WEST BENGAL 
7838549180

payalpandey620@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J352||Hypertrophy of adenoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coblator   Use of Coblator a surgical tool that uses radiofrequency energy and plasma to remove hypertrophied adenoid tissue in endoscopic adenoidectomy. Time taken 1-2 hours 
Intervention  Microdebrider  Use of Microdebrider a powered surgical tool used to remove hypertrophied adenoid tissue during endoscopic adenoidectomy. Time taken 1-2 hours  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1.Patient having Grade III or Grade IV adenoid hypertrophy, with or without bilateral tonsillar enlargement, with symptoms affecting speech, swallowing, breathing or sleep and having received at least one course of antibiotics.
2.Symptoms hampering day-to-day activities of patient.
3.Patients willing to participate in the study after giving informed consent.
4.Patients having no other debilitating systemic disease.
 
 
ExclusionCriteria 
Details  1.Age less than 3yrs and more than 15yrs.
2.Grade I or grade II disease.
3.Revision cases.
4.Patients with any debilitating systemic disease.
5.Cleft palate.
5.Cranio-facial abnormalities.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement in breathing  1 Month
3 Month
6 Month

 
 
Secondary Outcome  
Outcome  TimePoints 
Impact in Hearing Outcomes  1 Month
3 Month
6 Month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/12/2024 
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="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 - NO
Brief Summary  

Adenoidectomy is one of the most common procedures performed in paediatric otorhinolaryngology either alone or in conjunction with tonsillectomy or insertion of ventilation tubes or grommets. Although adenoidectomy is conventionally

done by curettage method by curetting the adenoid tissue blindly using St. Clair Thompson adenoid curette, newer methods including the use of suction diathermy, electrocautery, laser, coblation and endoscopic adenoidectomy is gaining popularity in modern times. Of these endoscopic adenoidectomy using power assisted Microdebrider adenoidectomy and Coblation adenoidectomy are the two new techniques available for adenoidectomy these days and are most commonly practiced in recent times. The advantages of endoscopic power assisted adenoidectomy over cold steel adenoidectomy has been well established in the literature. As adenoidectomy is one of the common paediatric surgical procedure there is always a concern to improve the outcomes and make postoperative experience more pleasant for the paediatric population. This study will look into the clinical outcomes following endoscopic assisted adenoidectomy by comparison between the two surgical methods by parameters like intraoperative time, intra-operative blood loss and post-operative pain, recovery time (ability to take solid food), residual tissue, post operative clinical improvement in breathing impact on hearing between the two methods.

 
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