Back to resultsA Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Primary Purpose
Carcinoma, Basal Cell
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
standard surgery
Mohs micrographic surgery
Sponsored by
About this trial
This is an interventional basic science trial for Carcinoma, Basal Cell
Eligibility 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
Sites / Locations
- Ninewells Hospital and Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
standard surgery
Mohs
Arm Description
basal cell carcinomas were excised with 4 mm margins
Basal cell carcinoma were removed via Mohs Micrographic surgery
Outcomes
Primary Outcome Measures
defect size after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00571363
Brief Title
A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Official Title
A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NHS Tayside
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We have compared to types of surgery to assess which one leaves the smaller surgical defect.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard surgery
Arm Type
Active Comparator
Arm Description
basal cell carcinomas were excised with 4 mm margins
Arm Title
Mohs
Arm Type
Active Comparator
Arm Description
Basal cell carcinoma were removed via Mohs Micrographic surgery
Intervention Type
Procedure
Intervention Name(s)
standard surgery
Intervention Description
excision with 4 mm margins
Intervention Type
Procedure
Intervention Name(s)
Mohs micrographic surgery
Intervention Description
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 Measure Information:
Title
defect size after surgery
Time Frame
immediately after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M Muller
Organizational Affiliation
NHS Tayside
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninewells Hospital and Medical School
City
Dundee
ZIP/Postal Code
DD3 6TU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19500127
Citation
Muller FM, Dawe RS, Moseley H, Fleming CJ. Randomized comparison of Mohs micrographic surgery and surgical excision for small nodular basal cell carcinoma: tissue-sparing outcome. Dermatol Surg. 2009 Sep;35(9):1349-54. doi: 10.1111/j.1524-4725.2009.01240.x. Epub 2009 Jun 3.
Results Reference
derived
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A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
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