| CTRI Number |
CTRI/2022/05/042822 [Registered on: 26/05/2022] Trial Registered Prospectively |
| Last Modified On: |
24/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to find out whether cantilever agrafts or spreader grafts are better in Nose correction surgery |
|
Scientific Title of Study
|
Assessment of effectiveness of Cantilever grafts versus Spreader grafts in Functional Septorhinoplasty using preoperative and postoperative nasal airflow measurements |
| Trial Acronym |
SRP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G S Shruthi |
| Designation |
Junior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
A Block 4th Floor OPD building AIIMS JODHPUR, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8940363672 |
| Fax |
|
| Email |
drshruthiganesan11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil soni |
| Designation |
Associate professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Basni Industrial Area Phase 2, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kapil soni |
| Designation |
Associate professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Basni Industrial Area Phase 2, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr G S Shruthi |
| Address |
Room no: 528, AIIMS PG & Residents hostel, Basni Industrial Area Phase 2, Jodhpur, Rajasthan-342005 |
| 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 G S Shruthi |
AIIMS JODHPUR |
A block 4th floor OPD Building Department of Otorhinolaryngology
Jodhpur
Jodhpur
RAJASTHAN |
8940363672
drshruthiganesan11@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 |
1.Patients undergoing Functional Septorhinoplasty with Cantilever Graft in the Department of Otorhinolaryngology, AIIMS Jodhpur
2.Patient who have undergone Functional Septorhinoplasty with Spreader Graft in the Department of Otorhinolaryngology, AIIMS Jodhpur
3.Patients aged more than or equal to 16 years
|
|
| ExclusionCriteria |
| Details |
1.Patients with other causes of nasal obstruction like nasal polyps, allergic rhinitis, nasal mass, ciliary abnormalities
2.Patients with coexistent pulmonary pathology
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in nasal airflow after septorhinoplasty with cantilever grafts than with spreader grafts |
changes in nasal airflow after septorhinoplasty at 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of preoperative and preoperative nasal airflow measurements |
2 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
28/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/05/2022 |
| 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 Yet Recruiting |
| 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 Ambispective cohort study to compare the preoperative and postoperative nasal airflow using nasal inspiratory peak flow meter after a period of 2 months of functional septorhinoplasty in patients undergoing the surgery in the department of Otorhinolaryngology,AIIMS,Jodhpur. |