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Surgical excision versus Mohs*micrographic surgery for cutaneous Squamous Cell Carcinoma

Completed
Conditions
skincancer
Squamous cell carcinoma
10040900
Registration Number
NL-OMON36835
Lead Sponsor
Catharina-ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Histologically confirmed cutaneous squamous cell carcinoma T1, stage 1, without high-risk characteristics. Squamous cell carcinoma at sun-exposed sides excluding lip and ear, tumour smaller than 20mm in diameter, tumours smaller than 4mm in dept and confined to the dermis, histologically well to moderately differentiated or verrucous subtype and without evidence of immune dysfunction.

Exclusion Criteria

Squamous cell carcinoma >= TNM II of the ear, lip and non-exposed sites (e.g. perineum, sacrum, sole of foot), arising in areas of radiation, chronic ulcers, tumours greater than 20mm in diameter, tumours greater 4mm in dept or extending down to the subcutaneous tissue, poorly differentiated, perineural involvement, acantolytic, incomplete excision, desmoplastic characteristics, angio-involvement, recurrent tumours, positive lymph nodes, immunosuppressive therapy (e.g. after organ transplantation), chronic immunosuppressive disease. Bowen*s disease, mucosal squamous cell carcinoma and actinic keratosis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The effectiveness of Mohs' micrographic surgery compared to surgical excision<br /><br>is measured according to three primary outcome measures: 1. Throughput time, 2.<br /><br>Quality of life and 3. Patient satisfaction.<br /><br>The throughput time is the time from the first contact at the out patient<br /><br>clinic untill the end of the treatment.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>As a secondary outcome we will study recurrence rate and costs of both<br /><br>treatments.</p><br>
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