Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhi… (NCT02106793) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.