| CTRI Number |
CTRI/2021/05/033710 [Registered on: 20/05/2021] Trial Registered Prospectively |
| Last Modified On: |
18/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of change in nasal airflow before and after septorhinoplasty |
|
Scientific Title of Study
|
Comparison of preoperative and postoperative nasal airflow in patients undergoing functional septorhinoplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swathi Krishna M |
| Designation |
Junior resident Department of Otorhinolaryngology |
| Affiliation |
AIIMS Jodhpur |
| Address |
A Block 4th floor OPD Building AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8304822343 |
| Fax |
|
| Email |
swathikrishnameloth111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Soni |
| Designation |
Associate Professor Department of Otorhinolaryngology |
| Affiliation |
AIIMS Jodhpur |
| Address |
A Block 4th floor OPD Building AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kapil Soni |
| Designation |
Associate Professor Department of Otorhinolaryngology |
| Affiliation |
AIIMS Jodhpur |
| Address |
A Block 4th floor OPD Building AIIMS Jodhpur
Ganganagar
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences Jodhpur Basni Industrial Area MIA 2nd Phase Basni Jodhpur Rajasthan 342005 |
| 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 |
| Dr Swathi Krishna M |
AIIMS Jodhpur |
A block 4th floor OPD Building Department of Otorhinolaryngology
Jodhpur
RAJASTHAN |
8304822343
swathikrishnameloth111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Functional Septorhinoplasty in the Department of Otorhinolaryngology, AIIMS Jodhpur |
|
| ExclusionCriteria |
| Details |
1.Patients with other causes of nasal obstruction like nasal polyps, allergic rhinitis, nasal mass, ciliary abnormalities
2.Patients with known coexistent pulmonary pathology
3.Patients with NOSE (Nasal Obstruction Symptom Evaluation) score less than 5
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in nasal airflow after septorhinoplasty |
Change in nasal airflow after septorhinoplasty at 2,4,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of preoperative and postoperative values of nasal airflow |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/06/2021 |
| 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 cohort study to compare the preoperative and postoperative nasal airflow using nasal inspiratory peak flow meter at 2, 4, 6 months of functional septorhinoplasty in patients undergoing the surgery in the Department of Otorhinolaryngology, AIIMS, Jodhpur. |