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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT02106793
First received: April 4, 2014
Last updated: March 31, 2016
Last verified: March 2016
  Purpose

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 Intervention Phase
Chronic Rhinosinusitis
Postoperative Nasal Synerchia
Drug: Mitomicin C
Drug: Identical placebo solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Mahidol University:

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

  • 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.

  • 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.


Estimated Enrollment: 388
Study Start Date: March 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106793

Locations
Thailand
Faculty of Medicine Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10600
Contact: Pawin Numthavaj, M.D.    +662 2000832    pawin.num@mahidol.ac.th   
Principal Investigator: Pawin Numthavaj, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Pawin Numthavaj, M.D. Faculty of Medicine Ramathibodi Hospital Mahidol University
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02106793     History of Changes
Other Study ID Numbers: MitomicinC_PostopESS
Study First Received: April 4, 2014
Last Updated: March 31, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017