ugol’s Iodine in surgical management of epithelial dysplasia in the oral cavity and oropharynx
Not Applicable
Completed
- Conditions
- Epithelial dysplasia in the oral cavity and oropharynxCancer
- Registration Number
- ISRCTN11348079
- Lead Sponsor
- HS Greater Glasgow and Clyde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. Provision of written informed consent
2. Age= 18 years old
3. Epithelial dysplasia of the oral cavity or oropharynx, undergoing primary surgical excision under general anaesthesia
Exclusion Criteria
1. Previous surgery or radiotherapy for head and neck cancer
2. Allergy to iodine
3. Previous diagnosis of head & Neck SCC in the past 5 years or active malignancy within 2 years of randomisation (except basal cell carcinoma or carcinoma of the cervix in-situ)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rates of surface dysplasia or carcinoma-in-situ at surface mucosal margins
- Secondary Outcome Measures
Name Time Method <br> 1. Two-year incidence of histologically confirmed transformation to SCC in the oral/cavity/oropharynx<br> 2. Occult SCC diagnosed histopathologically in excised mucosa<br> 3. Surface area of mucosa excised<br> 4. Extent of margin clearance in mm<br> 5. Surgeon decision to re-excise at the same site following positive margins<br> 6. Estimate of the two year recurrence rates of oral dysplasia<br> 7. Acceptability of the technique to surgeons (intervention treatment group)<br> 8. Safety of the technique (intervention treatment group)<br> 9. Assessment of Quality of Life changes<br>