| CTRI Number |
CTRI/2024/02/062954 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
effect of surgery ie septoplasty on quality of life in patients with deviated nasal septum |
|
Scientific Title of Study
|
Impact of septoplasty on quality of life in patients with deviated nasal septum |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanjeeb ahmad |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
department of ENT, 3rd floor, BL Taneja block, Lok Nayak hospital new delhi
New Delhi
DELHI
110002
India |
| Phone |
8587949087 |
| Fax |
|
| Email |
habibtanzeeb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
H C Taneja |
| Designation |
Director professor and head of department of Head and neck surgery |
| Affiliation |
Maulana Azad medical College lok Nayak hospital new delhi |
| Address |
3rd floor Blt block
Lok Nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9868399555 |
| Fax |
|
| Email |
taneja_hc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
H C Taneja |
| Designation |
Director professor and head of department of Head and neck surgery |
| Affiliation |
Maulana Azad medical College lok Nayak hospital new delhi |
| Address |
3rd floor Blt block
Lok Nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9868399555 |
| Fax |
|
| Email |
taneja_hc@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Blt 3rd floor Ent lok Nayak hospital new delhi |
| Type of Sponsor |
Government 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 H C Taneja |
Lok nayak hospital |
Department of ENT , 2nd floor B L Taneja blocklok nayak hospital
and associated
maulana azad medical
college Bahadur Shah
zafar marg New Delhi , 11002
New Delhi
DELHI |
9868399555
tanejahc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commettee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z789||Other specified health status, (2) ICD-10 Condition: Z86||Personal history of certain otherdiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All patients with septoplasty who will undergo septoplasty with symptomatic deviated nasal septum |
|
| ExclusionCriteria |
| Details |
Allergic rhinitis
Traumatic DNS
Granulation diseases
Atrophic rhinitis
Chronic rhinosinusitis
Pregnant female |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SNOT-22 score before and after septoplasty to compare improvement in nasal obstructive symptoms |
1 week,2 week,4 week,12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To record complications after septoplasty |
1 year |
|
|
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)
|
04/03/2024 |
| 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
|
Impact of septoplasty on quality of life in patients with deviated nasal septum |