Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
NCT00639652 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800
Last updated 2008-03-20
Summary
Currently, we conduct a prospective, randomized trial comparing the outcome of surgical excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and micronodular or sclerosing BCCs are not included in the randomized study. They are mainly operated using three-dimensional histology (3D-histology, micrographic surgery). In this observational study we measure the cosmetic result and the recurrence rate of all BCCs not included in the randomized trial.
Conditions
- Carcinoma, Basal Cell
Interventions
- PROCEDURE
-
3D-histology
The tumor is marked at the 12 o'clock-position. Excision with a safety margin between 2 and 10 mm, depending on tumor size and location. Plastic reconstruction. Removal of the specimen's margins and base as thin layers, using a scalpel. These primarily three-dimensional layers of the specimen's borders are flattened to one level and microscopically screened for tumor cells. 3D-histology is combined with representative vertical sections for histologic diagnosis. Consecutive excisions are performed topographically at the tumor-positive areas and 3D-histology is repeated until tumor-free margins are obtained.
- PROCEDURE
-
Shave excision
Tumor removal by shave excision with a safety margin. Healing by secondary intention. Histologic diagnosis of BCC type (nodular, superficial, morpheaform, micronodular, other type, mixed type) or diagnosis of another tumor than BCC. Comment on complete removal (R0 versus R1).
Sponsors & Collaborators
-
University Hospital Tuebingen
lead OTHER
Principal Investigators
-
Helmut Breuninger, M.D. · Eberhard Karls University Tuebingen, Department of Dermatology
-
Kay Brantsch, M.D. · Eberhard Karls University Tuebingen, Department of Dermatology
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- Germany
Study Locations
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