| CTRI Number |
CTRI/2024/05/066584 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Patient Satisfaction: Ear-Q Evaluation in Pinna Deformity Surgical Patients |
|
Scientific Title of Study
|
Assessment Of Change In Patient Reported Outcome Using EAR-Q In Patients With Pinna Deformities Undergoing Pinna Corrective Surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Meghna Kandwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
ROOM NO.-405, OPD-4A, Department Of Otorhinolaryngology, All India Institute Of medical sciences Jodhpur, Basini Phase-II, Jodhpur, Rajasthan-342005
All India Institute Of Medical Sciences, Jodhpur,Basini Phase- II Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07982209018 |
| Fax |
|
| Email |
mkandwal9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kapil Soni |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-412, OPD- 4A, Department of Otorhinolaryngology, AIIMS JODHPUR, BASINI PHASE-II, JODHPUR, RAJASTHAN-342005
All India Institute of medical sciences Jodhpur, Basini Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Meghna Kandwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room number-405, OPD-4A, Department of Otorhinolaryngology, AIIMS Jodhpur, Basini Phase-II, Jodhpur, Rajasthan-342005
All India Institute of medical sciences Jodhpur, Basini Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7982209018 |
| Fax |
|
| Email |
mkandwal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur,Industrial Phase II Basini,Jodhpur, Rajasthan-342005 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Meghna Kandwal |
All India Institute of Medical Sciences Jodhpur |
Room numberr 405, OPD-4A, Department of Otorhinolaryngology,All India Institute of Medical Sciences Jodhpur, Basini Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN |
7982209018
mkandwal9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H611||Noninfective disorders of pinna, (2) ICD-10 Condition: H948||Other specified disorders of ear in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged from 7 years and older with any pinna deformity undergoing pinna corrective surgery at AIIMS Jodhpur.
Patient willing to give consent for surgery. |
|
| ExclusionCriteria |
| Details |
Children less than 7 years of age
Patients undergoing revision surgery
Patient not willing to give consent for surgery.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the Change in the quality of life of patients undergoing Pinna Corrective surgery in patients with Pinna deformity |
One day Prior to the Surgery and
3 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To help surgeons in modifying the surgical techniques, and approaches to improve the quality of life of the patients |
Pre-operatively and 3 months post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
12/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Patients with pinna Deformities (Congenital or Traumatic) above the age of seven years, giving consent for pinna corrective surgery will be recruited in the study.
Impact of the surgery will be compared primarily in Psychological, Social and Appearance scales using EAR-Q scales. The questionnaire is made by McMaster University, specifically for ear. Every patient will be made to fill the EAR-Q assessment questionnaire, and the scores will be evaluated pre-operatively and Post surgery (after 3 months). The results will be compared in these two timelines.
|