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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36835
Enrollment
20
Registered
2012-09-27
Start date
2012-09-24
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

skincancer Squamous cell carcinoma

Interventions

Patients in the treatment group are treated with Mohs' micrographic surgery under local anesthesia. The squamous cell carcinoma will be removed with a margin of 2-3mm and frozen sections will be mad

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The effectiveness of Mohs' micrographic surgery compared to surgical excision is measured according to three primary outcome measures: 1. Throughput time, 2. Quality of life and 3. Patient satisfaction. The throughput time is the time from the first contact at the out patient clinic untill the end of the treatment.

Secondary

MeasureTime frame
As a secondary outcome we will study recurrence rate and costs of both treatments.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)