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

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ClinicalTrials.gov Identifier: NCT00571363
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : December 12, 2007
Sponsor:
Information provided by:
NHS Tayside

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

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Procedure: standard surgery Procedure: Mohs micrographic surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Study Start Date : January 2004
Actual Study Completion Date : December 2006

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. defect size after surgery [ Time Frame: immediately after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: December 12, 2007
Last Verified: December 2007

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