| CTRI Number |
CTRI/2026/03/106764 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized study to compare recovery after sinus surgery by placing a dexamethasone-medicated gel foam in the nasal passage versus not using any gel foam in patients with chronic sinusitis. |
|
Scientific Title of Study
|
RANDOMISED CONTROLLOED STUDY TO EVALUATE THE POST OPERATIVE EFFECT WITH
USE OF DEXAMETHASONE IMPREGNATED GELFOAM KEPT IN MIDDLE MEATUS AND
WITH THAT OF NO GEL FOAM IN MIDDLE MEATUS FOLLOWING FUNCTIONAL
ENDOSCOPIC SINUS SURGERY(FESS) IN CHRONIC RHINOSINUSITIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Sri Lakshmi |
| Designation |
Junior Resident |
| Affiliation |
Bharati vidyapeeth deemed university |
| Address |
Department of Otorhinolaryngology Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital dhankawadi Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
6301436931 |
| Fax |
|
| Email |
rsrilakshmirao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brig Jeevan R Galagali |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth ( Deemed to be University) Medical College and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital
Pune
MAHARASHTRA
411043
India |
| Phone |
9049000227 |
| Fax |
|
| Email |
jeevan.galagali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sri Lakshmi |
| Designation |
Junior Resident |
| Affiliation |
Bharati vidyapeeth deemed university |
| Address |
Department of Otorhinolaryngology Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital dhankawadi Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
6301436931 |
| Fax |
|
| Email |
rsrilakshmirao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ENT, Bharati Vidyapeeth Deemed University Medical College
Pune-Satara Road, Dhankawadi, Pune-411043,Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr R Sri Lakshmi |
| Address |
Bharati Vidyapeeth Deemed to be University Medical College and Hospital, Pune maharastra 411043 |
| 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 R Sri Lakshmi |
Bharati Hospital deemed to be university dhankawadi katraj pune maharastra |
Department of Otorhinolaryngology
Ground floor
Room no 20
Pune
MAHARASHTRA |
6301436931
rsrilakshmirao@gmail.om |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth medical college |
Approved |
| Bharati vidyapeeth medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone no gel foam |
4mg (1 amp)
Frequency-1 time
Total duration - 1 week |
| Intervention |
Dexamethasone soaked gel foam |
4mg (1 amp)
Frequency- 1 time
Total duration - 1 week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with nasal polyposis and without nasal polyposis |
|
| ExclusionCriteria |
| Details |
Patients below 18yrs
Other nasal pathologies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post-operative oedema with dexamethasone impregnated gel foam in
the middle meatus with that of no gel foam following FESS. |
1 week, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare post operative Synechia and secretions in middle meatus with dexamethasone impregnated gel foam the middle meatus with that of no gel foam following FESS. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/01/2027 |
| 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="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
Chronic rhinosinusitis is a chronic inflammation of the sinonasal mucosa clinically associated with 4 cardinal symptoms nasal obstruction drainage a decreased sense of smell and facial pain or pressure persisting for more than 12 weeks In few patients there is oedema inflammatory growth of nasal polyposis in the nasal cavity Those patients who underwent medical management and there is no regression in symptoms undergo Functional Endoscopic Sinus Surgery FESS improves the mucociliary clearance and drainage sinus pathways which help in the distribution of topical sprays reach the sinuses
Institutional ethical committee clearance will be obtained. All patients diagnosed with chronic rhinosinusitis posted for FESS. Routine preoperative laboratory investigations and CT PNS will be done, and are given a course of antibiotics and steroids, evaluated preoperatively using SNOT 22 scoring system . Patients are randomly divided into two groups. Group - A dexamethasone impregnated gel foam is placed in middle meatus test group and Group- B as control group with no gel foam in middle meatus, randomisation is done by computer generated numbers kept in an envelope and randomly picked in the operation theatre by the investigator and the outcome measurer is blinded. Functional endoscopic sinus surgery will be performed under general anesthesia using the same standardized anesthesia technique. Group A patients are loaded with dexamethasone impregnated gel foam intra op with bilateral nasal packing is done with betadine soaked IVALON nasal pack. Group B with no gel foam in middle meatus and bilateral nasal packing with betadine soaked IVALON nasal Post operatively SNOT 22 scoring done for evaluation of CRS symptoms and POSE SCORING on 1 week, 4 week and 8 week for evaluating and scoring
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