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

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ClinicalTrials.gov Identifier: NCT02106793
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Postoperative Nasal Synerchia Drug: Mitomicin C Drug: Identical placebo solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

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 Name: Mitomycin C

Placebo Comparator: Placebo
Identical placebo solution
Drug: Identical placebo solution
Identical placebo solution




Primary Outcome Measures :
  1. Postoperative Synerchia [ Time Frame: 1 year ]
    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 :
  1. Scoring of SNOT-22 [ Time Frame: 1 year ]
    Scoring of translated SNOT-22 disease-specific quality of life measurement

  2. Clinical Symptom Score [ Time Frame: 6 months ]
    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.

  3. SNOT-22 [ Time Frame: 6 months ]
    Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106793


Locations
Thailand
Faculty of Medicine Ramathibodi Hospital
Bangkok, Thailand, 10600
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Pawin Numthavaj, M.D. Faculty of Medicine Ramathibodi Hospital Mahidol University

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02106793     History of Changes
Other Study ID Numbers: MitomicinC_PostopESS
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Keywords provided by Mahidol University:
Chronic Rhinosinusitis
Mitomicin C
Postoperative nasal synerchia

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharmaceutical Solutions