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

Phase 3

Completed

• Conditions: Chronic Rhinosinusitis; Postoperative Nasal Synerchia
• Interventions: Drug: Identical placebo solution; Drug: Mitomicin C

• Registration Number: NCT02106793
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Study Start: 2015-03
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

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Exclusion Criteria

(None)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Identical placebo solution	Identical placebo solution
Mitomicin C	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Synerchia	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

Name	Time	Method
Scoring of SNOT-22	1 year	Scoring of translated SNOT-22 disease-specific quality of life measurement
Clinical Symptom Score	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	6 months	Disease-specific quality of life questionnaire SNOT-22 measurement which will be measured at baseline, 1 week, 1, 3, and 6 months.

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand