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OpenTrials
Completed

NCT Number: NCT02106793

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

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Key information

Conditions

Chronic Rhinosinusitis Postoperative Nasal Synerchia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Ramathibodi Hospital

Bangkok, 10600, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mitomicin C

Drug

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

Identical placebo solution

Drug

Identical placebo solution

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2014
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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