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

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis; Postoperative Nasal Synerchia

Treatments: Drug: Mitomicin C; Drug: Identical placebo solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02106793

MitomicinC_PostopESS

Details and patient eligibility

About

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

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

224 participants in 2 patient groups, including a placebo group

Mitomicin C

Experimental group

Description:

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.

Treatment:

Drug: Mitomicin C

Placebo

Placebo Comparator group

Description:

Identical placebo solution

Treatment:

Drug: Identical placebo solution