CompletedPhase 3

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

Thailand224 participantsStarted 2015-03

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Postoperative Synerchia

Timeframe: 1 year

Trial details

NCT IDNCT02106793

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-01

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