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
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Dr R Sri Lakshmi
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- To compare post-operative oedema with dexamethasone impregnated gel foam in
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with nasal polyposis and without nasal polyposis.
Exclusion Criteria
- •Patients below 18yrs Other nasal pathologies.
Outcomes
Primary Outcomes
To compare post-operative oedema with dexamethasone impregnated gel foam in
Time Frame: 1 week, 4 weeks, 8 weeks
the middle meatus with that of no gel foam following FESS.
Time Frame: 1 week, 4 weeks, 8 weeks
Secondary Outcomes
- 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)
Investigators
Dr R Sri Lakshmi
Bharati vidyapeeth deemed university