| CTRI Number |
CTRI/2024/11/077247 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of Endoscopic assisted curettage adenoidectomy and Conventional curettage adenoidectomy - A randomized controlled trial. |
|
Scientific Title of Study
|
Endoscopic assisted curettage adenoidectomy versus Conventional curettage adenoidectomy - a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Petchithai Priya S |
| Designation |
Post graduate |
| Affiliation |
Aarupadai veedu medical college and Hospital |
| Address |
A block first floor, Department of ENT and Head and Neck surgery,Aarupadai veedu medical college and hospital,Pondy-cuddalore main road, Kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7338751176 |
| Fax |
|
| Email |
priyapriya221999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishanth Savery |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical college and Hospital |
| Address |
A block first floor, Department of ENT and Head and Neck surgery
Aarupadai veedu medical college and hospital , Kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894547810 |
| Fax |
|
| Email |
docnishuu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishanth Savery |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical college and Hospital |
| Address |
A block first floor, Department of ENT and Head and Neck surgery
Aarupadai veedu medical college and hospital , Kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894547810 |
| Fax |
|
| Email |
docnishuu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College and Hospital,Pondy Cuddalore Main road, Kirumambakkam, Pondicherry-607402 |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College and Hospital |
| Address |
A block first floor, Department of ENT and Head and Neck surgery,Aarupadai Veedu Medical College and Hospital,Pondy cuddalore main road,Kirumambakkam,
Pondicherry - 607402 |
| 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 Petchithai Priya S |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
A block first floor, Department of ENT and Head and Neck surgery,Aarupadai Veedu Medical College and Hospital,Pondy cuddalore main road,Kirumambakkam,
Pondicherry - 607402
Pondicherry
PONDICHERRY |
7338751176
priyapriya221999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee, Aarupadai Veedu Medical College and Hospital |
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 |
Conventional Curettage Adenoidectomy |
To compare and contrast the presence of residual adenoid tissue in patients between Endoscopic assisted curettage adenoidectomy and Conventional Curettage Adenoidectomy |
| Intervention |
Endoscopic Assisted Curettage Adenoidectomy |
After randomization Group A will receive Conventional curettage adenoidectomy and Group B will receive Endoscopic Assisted Curettage Adenoidectomy and assessment will be done at 1st week, 1 month and 3 months post operatively. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patient in the age group of 5-25 years of both genders with clinical and radiological findings of chronic adenoid hypertrophy. |
|
| ExclusionCriteria |
| Details |
Patient less than 5 years or more than 25 years od age, patients with cleft palate or sub mucosal cleft palate,coagulative disorders,tumours of nose nd paranasal sinuses,choanal atresia,sinonasal polyposis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and contrast the presence of residual adenoid tissue between endoscopic
assisted curettage adenoidectomy and conventional curettage adenoidectomy . |
Assessment will be done at 3 months post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the symptomatic improvement in patients between endoscopic assisted
curettage adenoidectomy and conventional curettage adenoidectomy . |
Follow up visits at specified intervals for symptomatic assessment will be done at 1 st week ,
1 month and 3 months post operatively . |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/12/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The purpose of the study is to improve quality of life in patient’s undergoing adenoidectomy by comparing the presence of residual adenoid tissue and symptomatic improvement in patients between endoscopic assisted curettage adenoidectomy and conventional curettage adenoidectomy. |