| CTRI Number |
CTRI/2026/01/100959 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Posterior auricular artery as a landmark for identifying facial nerve trunk during Parotidectomy,in patients between 18 and 80 years of age with parotid swelling,by measuring the distance between the artery and facial nerve trunk so as to prevent injury to facial nerve during Parotidectomy. |
|
Scientific Title of Study
|
Posterior auricular artery as an anatomical landmark for identifying facial nerve trunk during Parotidectomy |
| 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 Gayathry PP |
| Designation |
Post Diploma DNB Resident ENT |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of Otorhinolaryngology
Kovai Medical Center and Hospital
Avinashi road
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
7561086747 |
| Fax |
|
| Email |
gayathrysinup777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diwakar M |
| Designation |
MS ENT,MRCS,FRCS(ORL-HNS) |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Room number 16
Department of Otorhinolaryngology
Kovai Medical Center and Hospital
Avinashi road
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9442250950 |
| Fax |
|
| Email |
dhiwamahi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diwakar M |
| Designation |
MS ENT,MRCS,FRCS(ORL-HNS) |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Room number 16
Department of Otorhinolaryngology
Kovai Medical Center and Hospital
Avinashi road
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9442250950 |
| Fax |
|
| Email |
dhiwamahi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kovai Medical Center and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Gayathry PP |
| Address |
Department of Otorhinolaryngology
Kovai Medical Center and Hospital
Avinashi road
Coimbatore
Tamil nadu
641014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Gayathry PP |
Kovai Medical Center and Hospital |
Room no 16,
Department of ENT,Head and neck surgery
Coimbatore
TAMIL NADU |
7561086747
gayathrysinup777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kovai Medical Center Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Identifying Posterior auricular artery during parotidectomy |
Axial Distance between Posterior auricular artery and facial nerve trunk in sagittal plane is measured during Parotidectomy and to explore the utility of posterior auricular artery as an anatomical landmark for identifying facial nerve trunk during parotidectomy |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients between 18 and 80 years of age undergoing parotidectomy during the study period will be included in this study. |
|
| ExclusionCriteria |
| Details |
All patients with previous history of parotid surgery will be excluded in this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To identify the relationship between posterior auricular artery and the facial nerve
trunk during Parotidectomy
2.To measure the axial distance between the Posterior auricular artery from its exit to the facial nerve trunk in saggital plane.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To validate the utility of Posterior auricular artery as an anatomical landmark for identifying facial nerve trunk during Parotidectomy |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/02/2026 |
| 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="0"
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
|
In this study the the utility of Posterior auricular artery as an anatomical landmark to identify facial nerve trunk during parotidectomy is explored by measuring the axial distance between the posterior auricular artery and the facial nerve trunk in sagittal plane during Parotidectomy and the collected data will be entered in Microsoft excel sheet and analysed with IBM SPSS Statistics and compared with published scientific theories |