A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

Carcinoma, Basal Cell Clinical Trial

Official title:

A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571363
• Other study ID #: 2003DS10
• Secondary ID: R&D Project ID:
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: December 11, 2007
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

We have compared to types of surgery to assess which one leaves the smaller surgical defect.

Description:

Patients with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 centimetre and 1 centimetre away from eyes, nose and ears were either randomized to undergo Mohs Micrographic Surgery or standard surgical excision. After the tumour had been removed the defect was measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with a clinical diagnosis of a nodular basal cell carcinoma of less than 1 cm, 1 cm away from eye, nose or ears

Exclusion Criteria:

• Subjects of less than 18 years of age

• Subjects unable to comply with instructions,

• Immunosuppressed subjects

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

Procedure:
• standard surgery
excision with 4 mm margins
• Mohs micrographic surgery
excision of basal cell carcinoma with 2 mm margins and immediate examination of margins for residual tumour. residual tumour was excised until complete tumour removal was achieved.

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital and Medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	defect size after surgery		immediately after surgery	No