Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective

• To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery

• To validate the Thai version of disease-specific quality of life tool SNOT-22

Secondary objectives

• To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo

• To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo

• To compare the side effects of Mitomicin C versus placebo

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Mitomycin; Mitomycins; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• All Thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for CRS

• Patients must not have following diseases or conditions

• Cystic fibrosis based on positive sweat test or DNA test

• Gross immunodeficiency (congenital or acquired)

• Congenital mucociliary problem (eg. Primary ciliary dyskinesia)

• Altered immune function such as patients with systemic vasculitis, systemic lupus erythematosus, end stage renal disease, cirrhosis, currently taking immunosuppressant or granulomatous disease

• Severe comorbidity with life expectancy of less than 1 year, such as advanced stage malignancy patient, or severe infection

• Patients are willing to participate and provide written informed consent

Exclusion Criteria:

(None)