| CTRI Number |
CTRI/2024/05/068200 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Role of Frontal Sinus Drainage Pathway Variations in Frontal Sinus Diseases |
|
Scientific Title of Study
|
A Clinico-pathological And Radiological Correlation Of Various Frontal Sinus Diseases With Anatomical Variations Of Frontal Sinus Drainage Pathways At The Level Of Frontal Recess And Osteo-meatal Complex As Detected On Imaging - Cross-sectional Study |
| 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 Aishwarya Vijayappan |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7558950989 |
| Fax |
|
| Email |
ashgeetvijay01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Jain |
| Designation |
Professor and HOD |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881836366 |
| Fax |
|
| Email |
sjain_med@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Jain |
| Designation |
Professor and HOD |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881836366 |
| Fax |
|
| Email |
sjain_med@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Wardha 442001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of ENT, Acharya Vinoba Bhave Rural Hospital,DMIHER Sawangi, Wardha 442001 |
| Type of Sponsor |
Private 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 |
| Dr Aishwarya Vijayappan |
Jawaharlal Nehru Medical College |
Out-patient and In-patient Department of ENT, AVBRH, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe)
Wardha
MAHARASHTRA |
7558950989
ashgeetvijay01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J348||Other specified disorders of noseand nasal sinuses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CT- Paranasal Sinus Axial, Coronal and Saggital Sections |
Radiological investigation will be used to study Frontal sinus drainage pathway variations at the level of osteomeatal complex and frontal recess and their role in sinonasal diseases will be as part of initial evaluation in pre-operative period |
| Intervention |
Diagnostic Nasal Endoscopy,
|
0 and 30 degree rigid endoscopes will be used to diagnose variations at osteomeatal complex and its role in sino-nasal pathologies will be done to know the extent of disease during initial screening for patients with mass in nasal cavity and after 1 week of medical management in patients with features suggestive of rhinosinusitis in the pre-operative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All the patients having frontal sinus diseases and sinonasal pathologies involving frontal sinus aged over 18 years. |
|
| ExclusionCriteria |
| Details |
1.History of previous sino-nasal surgery.
2.Contraindications for surgery.
3.Patient with cardiovascular and neurological disorder.
4.Maxillofacial fractures disrupting the frontal recess anatomy, hindering cell identification and frontal sinus drainage pathway
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Contribution of frontal cells and drainage pathway variants in the frontal sinus disease pathogenesis |
Pre-operative at baseline day 0 and histopathological findings after 7 days of reporting time from surgical clearance |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="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
|
The frontal sinus is described as the most difficult sinus to access surgically, given its challenging and variable anatomy including the possibility of pneumatization in different cells. Its close proximity to the noble structures such as cribriform plate, orbit and anterior ethmoidal artery makes them further challenging to approach surgically. Our study focuses on reviewing frontal sinus anatomically and its contribution in the disease pathogenesis which can help in the effective management and choice of surgical approaches. The aim of this study is to evaluate the anatomical variations of frontal sinus drainage pathways at the level of frontal recess and osteo-meatal complex and its implications in the development of frontal sinus disease. This study will help in bringing more insight in the role of frontal sinus and its variant drainage pathways in the etio-pathological process of frontal sinus disease. Moreover it will aid the clinicians in selecting the surgical technique and approach. |