| 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
|
|
|
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
|
|
|
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. |