| CTRI Number |
CTRI/2021/04/033114 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
29/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational cohort |
| Study Design |
Other |
|
Public Title of Study
|
COMPARING THREE SURGICAL OPTIONS FOR CONTROLLING DROOLING IN CHILDREN AND ADOLESCENTS |
|
Scientific Title of Study
|
A COMPARISON BETWEEN THREE SURGICAL MODALITIES IN THE CONTROL OF DROOLING IN CHILDREN AND ADOLESCENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HAGE DUNIYA |
| Designation |
JUNIOR RESIDENT ENT |
| Affiliation |
AIIMS JODHPUR |
| Address |
ROOM No. 405, A BLOCK,OPD BLOCK 4TH FLOOR, AIIMS JODHPUR RAJASTHAN.
B BLOCK,IPD BLOCK, 6TH FLOOR , AIIMS JODHPUR RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8302659712 |
| Fax |
|
| Email |
duniyahage27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIKRAM CHOUDHURY |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS JODHPUR |
| Address |
ROOM 409, A BLOCK,4TH FLOOR, OPD BLOCK, AIIMS JODHPUR RAJASTHAN
3rd Floor , Academics Building, AIIMS Jodhpur, Basni
Phase 2, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9596600990 |
| Fax |
|
| Email |
comatosebuddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HAGE DUNIYA |
| Designation |
JUNIOR RESIDENT ENT |
| Affiliation |
AIIMS JODHPUR |
| Address |
ROOM No. 405, A BLOCK,OPD BLOCK 4TH FLOOR, AIIMS JODHPUR RAJASTHAN.
B BLOCK,IPD BLOCK, 6TH FLOOR , AIIMS JODHPUR RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8302659712 |
| Fax |
|
| Email |
duniyahage27@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR BASNI INDUSTRIAL AREA BASNI 2ND PHASE JODHPUR RAJASTHAN 342005 |
| Type of Sponsor |
Government 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 Hage Duniya |
All India Institute Of Medical Sciences Jodhpur |
Department of Otorhinolaryngology OPD Block A Block AIIMS Jodhpur
Jodhpur
RAJASTHAN |
8302659712
duniyahage27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K117||Disturbances of salivary secretion, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents between 6 to 18years referred to Department of ENT from Department of Paediatrics AIIMS Jodhpur for intractable drooling inspite of adequate conservative management. |
|
| ExclusionCriteria |
| Details |
Patients with age less than 6 years and more than 18years |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the control in drooling using drooling quotient score, drooling severity and frequency score, visual analogue scale |
To assess the control in drooling using drooling quotient, drooling severity frequency score, visual analogue scale after 15days, 1month and 3months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
27/04/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective observational cohort study to compare between three surgical modalities in the control of drooling in children and adolescents assessed using drooling quotient score, drooling severity and frequency score and visual analogue scale among patients referred to Department of Otorhinolaryngology AIIMS Jodhpur from Department of Paediatrics over a period of 2years. Outcome assessment done preoperatively, post-op 1st month, 3rd month, 6th month. |