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

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106793
• Other study ID #: MitomicinC_PostopESS
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Postoperative Nasal Synerchia
• Sinusitis

Intervention

Drug:
• 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.
• Identical placebo solution
Identical placebo solution

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Scoring of SNOT-22	Scoring of translated SNOT-22 disease-specific quality of life measurement	1 year
Secondary	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
Secondary	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