| CTRI Number |
CTRI/2025/11/097309 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of adenoid and tonsil surgery in quality of life of children in Wayanad |
|
Scientific Title of Study
|
Quality of life in pediatric population before and after adenotonsillectomy in a tertiary care Centre in Wayanad |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samyutkha |
| Designation |
MS Resident |
| Affiliation |
DMMC,Wayanad |
| Address |
MS Resident,Department of ENT,DMMC,Naseera Nagar,Meppadi(P.O),Kerala,India(673577
Wayanad
KERALA
673577
India |
| Phone |
8547831686 |
| Fax |
|
| Email |
yuktha.sam21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.George K George |
| Designation |
Associate Professor |
| Affiliation |
DMMC,Wayanad |
| Address |
Department of ENT,DMMC,Naseera Nahar ,P.O Meppadi,kerala,Inidia-673577
KERALA
673577
India |
| Phone |
8547831686 |
| Fax |
|
| Email |
georgekgeorge7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samyutkha |
| Designation |
MS Resident |
| Affiliation |
DMMC,Wayanad |
| Address |
Department of ENT ,DMMC,Naseera Nagar,Meppadi(P.O),Wayanad Kerala,India-673577
KERALA
673577
India |
| Phone |
8547831686 |
| Fax |
|
| Email |
yuktha.sam21@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMMC,Naseera Nagar,Meppadi(P.O),Wayanad ,Kerala,India,673577 |
|
|
Primary Sponsor
|
| Name |
DMMC |
| Address |
Department of ENT ,DMMC,Naseera Nagar,Meppadi(P.O),Wayanad Kerala,India-673577 |
| 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 |
| Samyuktha |
Dmmc |
Naseera Nagar,Meppadi(P.O),Wayanad,Kerala-673577
Wayanad
KERALA |
8547831686
yuktha.sam21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,DMMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children above the age of 4 and below 14.
2.Children diagnosed with chronic adenotonsillitis and are planned for adenotonsillecotmy.
|
|
| ExclusionCriteria |
| Details |
1.Children with craniofacial deformities, neuromuscular diseases, behavioral diseases.
2.Children with psychiatric illness.
3.Children previously subjected to speech therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean pediatric quality of life score from pre-operative to 3 months after adenotonsillecotmy ,measured by a validated parent-proxy/child Qol questionnaire. |
Baseline-preoperative time(within 2 weeks before surgery).
endtime-3 months post surgery. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
All
children presenting to ENT OPD with symptoms of chronic adenotonsillitis will
be included in the study. An informed consent will be obtained from the
parent/guardian of each child enrolled in the study. Detailed history, general physical
examination, ear, nose and throat examination will be done. Diagnostic nasal
endoscopy and X-ray nasopharynx also would be used. After doing all of the
above mentioned, presence of adenotonsillar hypertrophy will be confirmed. Following
which parents/guardians will be asked to fill questionnaires on quality of life(OSA
18 and PVRQOL) of their children pre-operatively. Later 3 months after adenotonsillectomy,
they will be again asked to fill in the same questionnaires to assess the
impact of surgery in the child’s life. |