| CTRI Number |
CTRI/2023/02/050118 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
26/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY OF VARIOUS MASSES IN NOSE AND SINUS |
|
Scientific Title of Study
|
CLINICO-PATHOLOGICAL PROFILE OF VARIOUS SINONASAL MASSES :A STUDY FROM A TERTIARY CARE HOSPITAL, BHAVNAGAR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annapoorna k |
| Designation |
1st Year ENT Resident |
| Affiliation |
Governmaent Medical College , Bhavnagar |
| Address |
ENT DEPARTMENT, ROOM NO 603 , PG2 HOSTEL , SIR T HOSPITAL CAMPUS , JAIL ROAD , BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
8606616465 |
| Fax |
|
| Email |
annapoornamanohar9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSushil G Jha |
| Designation |
Head of Department in Otorhinolaryngology |
| Affiliation |
Government Medical College,Bhavnagar |
| Address |
SIR T HOSPITAL JAIL ROAD BHAVNAGAR GUJARAT
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Kumar Meena |
| Designation |
3rd Year Resident |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
ENT DEPARTMENT ,24 PG 1 MEDICAL HOSTEL SIR T HOAPITAL JAIL ROAD BHAVNAGAR GUJARAT
Bhavnagar
GUJARAT
364001
India |
| Phone |
7615023002 |
| Fax |
|
| Email |
manojkm970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolarngology, Sir T Hospital , jail road Bhavnagar. |
|
|
Primary Sponsor
|
| Name |
Department of Otorhinolaryngology |
| Address |
Sir T Hospital Bhavnagar. |
| 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 |
| DrAnnapoorna k |
Department of otorhinolaryngology and head and neck surgery |
ENT Department , Near cancer care centre, Sir T hospital, Jail road, Bhavnagar
Bhavnagar
GUJARAT |
8606616465
annapoornamanohar9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERMENT MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with masses in sinonasal region.
|
|
| ExclusionCriteria |
| Details |
Patients with intracranial lesions with nasal extension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clivico-pathological profile and rate of recurrence in various sininasal masses. |
8months (02/01/2023 - 31/08/2023) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Demographic data, clinico-pathological profile and various diagnostic and treatment modalities.
To estimate Rate of recurrence
|
8months (02/01/2023-31/08/2023)
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
§Otorhinolaryngologist encounter nasal masses in routine OPD practice.Hence it is essential to diagnose them and prevent any untreatable complications. §There are a variety of neoplastic and non neoplastic masses of nasal cavity , paranasal sinus and nasopharynx which are commonly encountered in clinical practice. §Nonneoplastic cell growth can be of 3 types- Hyperplasia, Dysplasia, Metaplasia. §Both neoplastic and nonneoplastic lesions may present with similar symptomatology such as nasal obstruction , nasal discharge, headaches, sneezing,epistaxis, headache to name a few. §Examples of sinonasal masses include-Antrochoanal polyp,inverted papilloma, juvenile nasopharyngeal angiofibroma,ethmoidal polyp, allergic fungal sinusitis, allergic fungal polyposis. |