Back to resultsMitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis
Primary Purpose
Chronic Rhinosinusitis, Postoperative Nasal Synerchia
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Mitomicin C
Identical placebo solution
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis focused on measuring Chronic Rhinosinusitis, Mitomicin C, Postoperative nasal synerchia
Eligibility Criteria
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)
Sites / Locations
- Faculty of Medicine Ramathibodi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mitomicin C
Placebo
Arm 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.
Identical placebo solution
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Scoring of SNOT-22
Scoring of translated SNOT-22 disease-specific quality of life measurement
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.
SNOT-22
Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02106793
Brief Title
Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Postoperative Nasal Synerchia
Keywords
Chronic Rhinosinusitis, Mitomicin C, Postoperative nasal synerchia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitomicin C
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo solution
Intervention Type
Drug
Intervention Name(s)
Mitomicin C
Other Intervention Name(s)
Mitomycin C
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Identical placebo solution
Intervention Description
Identical placebo solution
Primary Outcome Measure Information:
Title
Postoperative Synerchia
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Scoring of SNOT-22
Description
Scoring of translated SNOT-22 disease-specific quality of life measurement
Time Frame
1 year
Title
Clinical Symptom Score
Description
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.
Time Frame
6 months
Title
SNOT-22
Description
Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawin Numthavaj, M.D.
Organizational Affiliation
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10600
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis
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