| CTRI Number |
CTRI/2024/04/066245 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to investigate the anatomical variations in the arteries supplying the pinna and its impact on the outcomes of auricular reconstruction surgeries |
|
Scientific Title of Study
|
Descriptive study of the anatomical variations of the Superficial Temporal artery and the Posterior Auricular Artery in the patients with unilateral microtia and its implications on the surgical outcomes in Auricular reconstruction surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
STAVAN JARIWALA |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of Otorhinolaryngology- Head and Neck Surgery, Room no. 4058
4th Floor, Teaching Block,
AIIMS New Delhi
New Delhi DELHI 110029 India |
| Phone |
6375068728 |
| Fax |
|
| Email |
stavjari@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. Rakesh Kumar |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of Otorhinolaryngology- Head and Neck Surgery, Room no. 4058
4th Floor, Teaching Block,
AIIMS New Delhi
New Delhi DELHI 110029 India |
| Phone |
9868397461 |
| Fax |
|
| Email |
winirk@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Stavan Jariwala |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of Otorhinolaryngology- Head and Neck Surgery, Room no. 4085
4th Floor, Teaching Block,
AIIMS New Delhi
New Delhi DELHI 110029 India |
| Phone |
6375068728 |
| Fax |
|
| Email |
stavjari@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,
Sri Aurobindo Marg, Ansari Nagar, New Delhi, Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
All India Institute of Medical Sciences,
Sri Aurobindo Marg, Ansari Nagar, New Delhi, Delhi, 110029 |
| 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 |
| Stavan Jariwala |
All India Institute of Medical Sciences, New Delhi |
Department of Otorhinolaryngology,
Room no. 4058, 4th floor, Teaching Block,
All India Institute of Medical Sciences,
Sri Aurobindo Marg, Ansari Nagar, New Delhi, Delhi, 110029 New Delhi DELHI |
6375068728
stavjari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q172||Microtia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All cases of unilateral microtia undergoing auricular reconstruction aged more than 6 years.
2. Any gender.
3. Individuals giving consent to participate in the study Willing to give written informed consent.
4. Chest circumference of atleast 60 cm at the level of xiphoid process.
|
|
| ExclusionCriteria |
| Details |
1. Patient who is not willing to participate in the study.
2. Patient who is unfit for surgery under general anaesthesia.
3. Patients with low hairline microtia.
4. Patients with less than 6 years of age.
5. Patients who have undergone previous ear surgery.
6. Patients with severe facial abnormalities.
7. Patient with chest wall abnormalities.
8. Patient for whom computed tomography is contraindicated.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for anatomical variations in Superficial Temporal artery and Posterior Auricular artery by measuring their diameter and branching patterns |
CT Angiography will be done before these patients undergo surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine the post operative surgical outcomes of auricular reconstruction surgery in cases of unilateral microtia based on their vascular anatomy. |
During follow up of patients in the post operative period |
|
|
Target Sample Size
|
Total Sample Size="3" Sample Size from India="3"
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)
|
27/04/2024 |
| 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 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
|
A purposive sampling of all patients attending the ENT clinics at AIIMS
OPD will be undertaken. Patients with Unilateral Microtia will be evaluated and
those fulfilling the inclusion and exclusion criteria will be recruited. They
will be screened for severe facial abnormalities, chest wall abnormalities and
low hairline microtia. Those deemed unfit for surgery under General Anesthesia
by the Anesthesiology team will be excluded and will be provided other suitable
alternative treatment options.
Patients recruited for the study will be explained in complete detail
about the procedure and an Informed Written consent will be sought.
Following this, detailed workup and assessment of the patients will be
done and a basic proforma including demographic and clinical details will be
filled.
Clinical Photographs for medical, research and academic purpose will be
taken only after due consent from the patients.
Subsequent to this, patients will undergo CT Angiography. The diameter
of STA and PAA will be measured on CT Angiography. Branching pattern of STA
will also be assessed.
The surgery will be done in a staged manner, utilizing Modified Nagata
technique employing Temporoparietal flap based on Superficial Temporal Artery
and customized to suit the individual patient. Intra operative proforma
including size, shape and location of flap, time taken for temporoparietal
flap harvesting and total time of surgery from draping to closure will be
filled separately for both stages.
There
would be minimum 3 months gap between both stages. Patients will stay admitted
in the ENT ward for few days after each stage during which they will be closely
observed to look for any complications, and will be subsequently discharged and
will be followed up in OPD.
Proforma
will be updated for details in the post-op period to look for any complication.
The socio-demographic and
clinical variables will undergo tabulation, and measures of central tendency
will be computed for analysis. Quantitative variables will be presented as mean
values, while categorical variables will be expressed
as frequencies and percentages. Descriptive statistics will be employed to
analyze the data obtained. |