| CTRI Number |
CTRI/2024/07/070796 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two techniques of balloon sinuplasty and endoscopic sinus surgery in patients of chronic rhinosinusitis without nasal polyposis in terms of success rate and efficacy |
|
Scientific Title of Study
|
Efficacy of balloon sinuplasty versus endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis A non randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Virendra Kumar |
| Designation |
PG Junior Resident |
| Affiliation |
Uttar Pradesh University Of Medical Sciences ,Saifai Etawah U.P |
| Address |
Roon No 447 Old Building Department of ENT and Head and Neck Surgery, UPUMS, Saifai Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
08009423818 |
| Fax |
|
| Email |
virendrakumarms1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhay Kumar |
| Designation |
Professor |
| Affiliation |
Uttar pradesh medical sciences saifai,etawah |
| Address |
Roon No 447 Old Building Department of ENT and Head and Neck Surgery, UPUMS, Saifai Etawah 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9868922848 |
| Fax |
|
| Email |
abhaykr20@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Virendra Kumar |
| Designation |
PG Junior Resident |
| Affiliation |
Uttar pradesh medical sciences saifai,etawah |
| Address |
Roon No 447 Old Building Department of ENT and Head and Neck Surgery, UPUMS, Saifai Etawah,206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
08009423818 |
| Fax |
|
| Email |
virendrakumarms1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh university of medical Sciences Saifai Etawah
Uttar Pradesh pin code 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh university of medical Sceinces Saifai Etawah |
| Address |
Uttar Pradesh University of medical sciences saifai Etawah
Uttar Pradesh 206130
Etawah
UTTAR PRADESH
206130
India |
| 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 Virendra Kumar |
Uttar Pradesh University of Medical Sciences |
Room no 447 old building department of ENT U.P.University of medical sciences,saifai, Etawah
(UP) 206130
Etawah
UTTAR PRADESH |
08009423818
virendrakumarms1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttar Pradesh University of medical sciences saifai.Etawah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J320||Chronic maxillary sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
balloon sinuplasty |
balloon sinuplasty system uses
to dilate block ostium of maxillary sinus by using balloon sinus catheter through the nasal cavity reach into the ostium of maxillary sinus confirm by illuminating guide wire and check the maxillary glow and dilate the balloon in the ostium for 10 sec for 10-12 mm of h2o pressure . |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with chronic rhinosinusitis without nasal polyposis based on clinical and radiological criteria.
Unilateral or bilateral maxillary chronic rhinosinusitis which had been unresponsive to 3 weeks of medical management.
Willingness to undergo either Balloon sinuplasty or Endoscopic sinus surgery based on clinical assessment and shared decision making. |
|
| ExclusionCriteria |
| Details |
Patients with chronic rhinosinusitis with nasal polyposis.
Isolated ethmoidal or infundibular disease.
Patients with contraindications to either Balloon sinuplasty or endoscopic sinus surgery.
Associated condition like ciliary dysmotility syndrome, mucopolysaccharidosis or cystic fibrosis.
Presence of distorted osteo-meatal unit anatomy.
Allergic fungal rhinosinusitis.
Revision surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
efficacy of balloon sinuplasty in comparison to endoscopic sinus surgery for CRS without nasal polyposis in term of Sucess rate.
|
efficacy of balloon sinuplasty in comparison to endoscopic sinus surgery for CRS without nasal polyposis in term of Sucess rate.
Check by regular follow up at interval of 1 week,3months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the relief in patient symptomsusing SNOT-22 between two study groups.
Assess the results BSP and ESS by LUND KENNEDY SCORE.
quality of life improvement.
Patient satisfaction.
|
AT TIME INTERVAL OF 1st week. 3 months, and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
27/07/2024 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
title of this study was A non Randomized controlled trial ,of Efficacy of balloon sinuplasty versus endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis. This study will be conducted in department of ENT at UPUMS Saifai, aiming to enroll 46 eligible patients age 15-60 years with CRS without nasal polyposis .Pt. selected on the basis of inclusion and exclusion criteria . Data will be collected through comprehensive pre operative assessments , intra operative , records and post operative follow up at 1 week , 3 months, and 6 months.
Aim of this study is compare Efficacy of balloon sinuplasty versus endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis.
Objective of this study determine -to determine the efficacy of balloon sinuplasty in compression to endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis in term of Sucess rate.
To compare the symptoms relief in patients , using SNOT 22 scoring
expected outcome Balloon sinuplasty is minimally invasive procedure |