| CTRI Number |
CTRI/2021/05/033688 [Registered on: 20/05/2021] Trial Registered Prospectively |
| Last Modified On: |
16/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the variations of the frontal sinus and their association with CT scan signs of sinusitis |
|
Scientific Title of Study
|
A prospective study on the Anatomical variations of the Frontal Sinus and their association with Computer Tomographic signs of sinusitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Koliyote Snigdha Girish |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of ENT, New OPD block, Kasturba Hospital Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9833150282 |
| Fax |
|
| Email |
snigdha.koliyote@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Singh |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Otorhinolaryngology, Kasturba Medical college and Hospital, Madhavnagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9900405817 |
| Fax |
|
| Email |
rohit.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koliyote Snigdha Girish |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of ENT, New OPD block, Kasturba Hospital, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9833150282 |
| Fax |
|
| Email |
snigdha.koliyote@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal
Udupi-Hebri road, Madhav Nagar, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Koliyote Snigdha Girish |
| Address |
Room No 421, New International Hostel A block, Manipal Drive, Manipal 576104 |
| 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 Koliyote Snigdha Girish |
Department of ENT, Kasturba Hospital Manipal |
Udupi-Hebri road, Madhav Nagar, Manipal.
Udupi
KARNATAKA |
9833150282
snigdha.koliyote@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J321||Chronic frontal sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with complete multiplanar CT scans of the Nose and Paranasal Sinuses with less than 3 mm cuts
2.Patients above 18 years of age
|
|
| ExclusionCriteria |
| Details |
1. Patients less than 18 years of age
2. Patients with Sino-nasal neoplasms
3. Patients with Fungal sinusitis
4. Patients with history of previous sinus surgery
5. Patients with Maxillofacial trauma
6. Patients with incomplete CT scans, or with CT scans with cuts more than 3mm
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Prevalence of the various types of frontal cells will be noted.
• The classification which helps classify the cells better will be identified.
• The frontal cells with higher prevalence of sinusitis will be identified.
|
One and a half years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
31/05/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study of patients undergoing Multiplanar CT scans of the Nose and Paranasal Sinus (less than 3 mm cuts) at Kasturba Hospital Manipal will be identified using the above mentioned inclusion and exclusion criteria. The Frontal sinus and frontal recess region in the CT Scans will be evaluated and then classified according to Kuhn’s classification and the IFAC classification. After classification the prevalence of each type of frontal cell will be identified and compared. Presence of radiological sinusitis of the frontal sinus and frontal recess will also be documented. The better classification system between the two will be identified. |