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

Study Overview
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Brief Summary
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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

Official Title
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Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis

Conditions
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Chronic Rhinosinusitis, Postoperative Nasal Synerchia

Intervention / Treatment
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* Drug: Mitomicin C
* Drug: Identical placebo solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitomicin C<br>Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side. | Drug: Mitomicin C<br>* Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side.<br>* Other names: Mitomycin C;|
| Placebo Comparator: Placebo<br>Identical placebo solution | Drug: Identical placebo solution<br>* Identical placebo solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Synerchia | The primary outcome of interest is time to event, with the event as the occurrence of nasal synechia. The date of surgery will be used as the beginning date, and the last date will be the date that patient was defined as synechia, or the end of the study period if that patient does not have synechia on follow up. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring of SNOT-22 | Scoring of translated SNOT-22 disease-specific quality of life measurement | 1 year | 
| Clinical Symptom Score | Clinical symptom score of patients, measured by visual analog score which will be given by research nurse for a patient to fill in at baseline, 1 week, 1, 3, and 6 months. | 6 months | 
| SNOT-22 | Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Rhinosinusitis, Mitomicin C, Postoperative nasal synerchia