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

This study has been completed.
Sponsor:
Information provided by:
NHS Tayside
ClinicalTrials.gov Identifier:
NCT00571363
First received: December 11, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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


Condition Intervention
Carcinoma, Basal Cell
Procedure: standard surgery
Procedure: Mohs micrographic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma

Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • defect size after surgery [ Time Frame: immediately after surgery ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2004
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: standard surgery
basal cell carcinomas were excised with 4 mm margins
Procedure: standard surgery
excision with 4 mm margins
Active Comparator: Mohs
Basal cell carcinoma were removed via Mohs Micrographic surgery
Procedure: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00571363

Locations
United Kingdom
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD3 6TU
Sponsors and Collaborators
NHS Tayside
Investigators
Principal Investigator: Frank M Muller NHS Tayside
  More Information

No publications provided by NHS Tayside

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank Muller, Specialist Registrar in Dermatology, NHS Tayside,
ClinicalTrials.gov Identifier: NCT00571363     History of Changes
Other Study ID Numbers: 2003DS10, R&D Project ID: 2003DS10
Study First Received: December 11, 2007
Last Updated: December 11, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on July 31, 2014