| CTRI Number |
CTRI/2019/02/017402 [Registered on: 01/02/2019] Trial Registered Prospectively |
| Last Modified On: |
01/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of outcome and Quality of Life assessment in patients with chronic allergy after nasal irrigation using normal saline with budesonide after endoscopic nose surgery |
|
Scientific Title of Study
|
A Prospective Longitudinal study of clinical outcome and Quality of Life assessment in patients with Chronic Rhinosinusitis after nasal irrigation using normal saline with budesonide after Functional Endoscopic Sinus Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PC Verma |
| Designation |
Professor and head |
| Affiliation |
JLN Medical college |
| Address |
Room no 70
ENT Department
JLN Medical college
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008278 |
| Fax |
|
| Email |
drpcverma.ent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PC Verma |
| Designation |
Professor and head |
| Affiliation |
JLN Medical college |
| Address |
Room no 70
ENT Department
JLN Medical college
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008278 |
| Fax |
|
| Email |
drpcverma.ent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PC Verma |
| Designation |
Professor and head |
| Affiliation |
JLN Medical college |
| Address |
Room no 70
ENT Department
JLN Medical college
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008278 |
| Fax |
|
| Email |
drpcverma.ent@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical college
ajmer |
|
|
Primary Sponsor
|
| Name |
JLN MEDICAL COLLEGE |
| Address |
JLN MEDICAL COLLEGE
AJMER |
| 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 GIRIRAJ PRASAD TRIVEDI |
JLN MEDICAL COLLEGE |
DEPARTMENT OF ENT
JLN MEDICAL COLLEGE
Ajmer
RAJASTHAN |
8824176231
gptparul007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,JLN medical college,ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DR GIRIRAJ PRASAD TRIVEDI |
Resident doctor Department of
ENT JLN Medical college Ajmer |
| Intervention |
DR.P.C. VERMA |
Senior Professor AND HOD
ENT Department JLN medical
college ajmer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronic rhinosinusitis diagnosed according to European position paper on rhinosinusitis and nasal polyps EPOS 2012.
Characteristic changes in pre-operative computed tomography of paranasal sinuses assessed according to EPOS 2012.
Chronic rhinosinusitis patients with bilateral nasal polyps who had not improved after medical treatment.
Chronic rhinosinusitis patients without nasal polyps who had not improved after medical treatment.
|
|
| ExclusionCriteria |
| Details |
• Other subgroups of CRS; Secondary CRS.
• Age under 18 years.
• Pregnancy.
• Immunodeficiency.
• Patients who are undergoing revision endoscopic sinus surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate postoperative nasal irrigation practices and the compliance of patients after FESS. Short-term outcomes in post-FESS patients using nasal saline with steroid will be assessed. |
Duration of study is around one year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate postoperative nasal irrigation practices and the compliance of patients after FESS. Short-term outcomes in post-FESS patients using nasal saline with steroid will be assessed. |
Duration of study is around one year. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/02/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim: The study is planned to
evaluate postoperative nasal irrigation practices and the compliance of
patients after FESS. Short-term outcomes in post-FESS patients using nasal
saline with steroid will be assessed.
Primary objective:
1. To
assess the compliance and factor affecting compliance of patients for nasal
saline irrigation after Functional Endoscopic Sinus Surgery.
2. Assessment
and comparison of changes in QoL based on the 22-item Sinonasal Outcomes Test
(SNOT-22) after functional endoscopic sinus surgery with topical nasal steroids
and normal saline irrigation.
3. Assessment
and comparison of changes in endoscopic finding using Lund-Kennedy Endoscopy
score after functional endoscopic sinus surgery with topical nasal steroids and
normal saline irrigation. Secondary Objective:
1. To assess significant
and local adverse effect of nasal irrigation and their impact on compliance of
nasal irrigation. |