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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-01

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

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Detailed Description

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Conditions

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Chronic Rhinosinusitis Postoperative Nasal Synerchia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mitomicin C

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.

Group Type EXPERIMENTAL

Mitomicin C

Intervention Type DRUG

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.

Placebo

Identical placebo solution

Group Type PLACEBO_COMPARATOR

Identical placebo solution

Intervention Type DRUG

Identical placebo solution

Interventions

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Mitomicin C

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.

Intervention Type DRUG

Identical placebo solution

Intervention Type DRUG

Other Intervention Names

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Mitomycin C

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