| CTRI Number |
CTRI/2019/06/019589 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
06/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Normal differences in the structure of paranasal sinuses and nasal cavity present in patients with sinusitis with complications - A descriptive study |
|
Scientific Title of Study
|
Anatomical variations of paranasal sinuses and nasal cavity present in patients with complicated sinusitis - A descriptive study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SURYA R |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of ENT,
JIPMER,
Dhanvantri Nagarn
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598350338 |
| Fax |
|
| Email |
snsrsurya@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SIVARAMAN G |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of ENT,
JIPMER,
Dhanvantri Nagarn
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9944690172 |
| Fax |
|
| Email |
gsivram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SIVARAMAN G |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of ENT,
JIPMER,
Dhanvantri Nagarn
Puducherry.
PONDICHERRY
605006
India |
| Phone |
9944690172 |
| Fax |
|
| Email |
gsivram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar,
Puducherry,
India.
Postal Code: 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Puducherry-605 006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SURYA R |
JIPMER |
Department of ENT,
JIPMER,
Dhanvantri Nagar,
Puducherry - 605006
Pondicherry
PONDICHERRY |
7598350338
snsrsurya@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J019||Acute sinusitis, unspecified, (2) ICD-10 Condition: J32||Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients, including children, with complicated sinusitis presenting in ENT or Ophthalmology OPD, EMS, admitted in ENT or Ophthalmology wards. |
|
| ExclusionCriteria |
| Details |
Patients with history of prior sinonasal surgery
Patients with sinonasal malignancy
Patients with skull base fracture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the anatomical variations in the paranasal sinuses and nasal cavity in patients with complicated sinusitis |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for any association the anatomical variations in the paranasal sinuses and nasal cavity in patients with complicated sinusitis |
3 years |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/06/2019 |
| 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="3"
Months="0"
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)?
|
|
Brief Summary
|
Though sinusitis is a fairly common disease, only a few patients progress to complications. Anatomical factors could be a reason for the disease progression. From this study, the various variations in the nasal cavity and paranasal sinuses in patients with complicated sinusitis can be identified. By knowing these variations, the prevalence of each variation can be ascertained. Further studies can be taken up in the future to look for an association of each variation with the pathogenesis of the disease and the disease progression. |