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To evaluate the outcomes of placing steroid soaked absorbable material in the postoperative sinus cavity of patients undergoing surgery for chronic rhinosinusitis with nasal polyps.

Effect of targeted intrasinus application of steroid soaked gelfoam on postoperative outcomes in patients with chronic rhinosinusitis with nasal polyps. - STER â?? GEL trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054252
Enrollment
50
Registered
2023-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J330- Polyp of nasal cavity

Interventions

Intervention1: TRIAMCINOLONE ACETATE SOAKED GELFOAM: Steroid arm will have one time application of 2ml triamcinolone acetate solution (40mg/ml)soaked gelfoam , which will be placed in the postoperativ

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Chronic rhinosinusitis with nasal polyposis refractory to maximal medical treatment and planned for endoscopic sinus surgery

Exclusion criteria

Exclusion criteria: a. Patients who used oral or nasal corticosteroids for 4 weeks before operation b. Patients undergoing revision endoscopic sinus surgery c. Presence of active infection within the sinus d. Patients with Allergic fungal rhinosinusitis or invasive fungal sinusitis

Design outcomes

Primary

MeasureTime frame
Variables assessed Preoperative assessment: 1) VAS score 2) SNOT 22 scores 3) Modified Lund Kennedy endoscopy scores 4) Lund Mackay CT scores Postoperative assessment: 1) VAS score 2) SNOT 22 scores 3) Modified Lund Kennedy endoscopy scoresTimepoint: Postoperative assessment: Day 7-10, 3 months

Secondary

MeasureTime frame
Correlate the histopathological findings and total tissue eosinophil count with clinical and endoscopic outcomes.Timepoint: 3 months;Determine the incidence of eosinophilic and non-eosinophilic nasal polyps based on total tissue eosinophil count in the study population, . Timepoint: 1 month;To correlate the outcomes of eosinophilic and non-eosinophilic nasal polyps with the interventionTimepoint: 3 month

Countries

India

Contacts

Public ContactManu Thampi

Christian Medical College Vellore

regikurien@cmcvellore.ac.in9655806300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026