FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
Close