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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis; Postoperative Nasal Synerchia
• Intervention / Treatment: Drug: Mitomicin C; Drug: Identical placebo solution

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10600
    • Faculty of Medicine Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Mitomycin C
Placebo Comparator: Placebo; Identical placebo solution	Drug: Identical placebo solution; Identical placebo solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Pawin Numthavaj, M.D., Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Rhinosinusitis; Mitomicin C; Postoperative nasal synerchia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: MitomicinC_PostopESS