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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.
Disinfection
Local anesthesia
Surgery
Dressing
Preparation with paraffin for histopathologic evaluation
Staining with hematoxylin-eosin
Adjuvant radiotherapy is not applied in any of our patients.
If histopathology discovers another tumor than BCC, the tumor is excluded.
If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
Patients who provide no feedback receive phone calls.
The patient receives a letter containing a list of the BCCs treated within the study. She or he is asked to visit the private practitioner with the list after 12 and 48 months (+/- 30 days) referring to the last operation in the recruitment period. The practitioner or the patient return the questionnaire to our department.
The letter contains a questionnaire about suspicion of recurrence of BCC.
The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
When follow-up is closed for an individual patient, the reason is recorded:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. 3D-histology | Nodular, micronodular, or sclerosing BCCs |
| |
| 2. Shave excision | Superficial BCCs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-histology | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of basal cell carcinoma (BCC) | Within 4 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner. | 12 and 48 months after surgery | |
| Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient. |
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Inclusion Criteria:
Exclusion Criteria:
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BCCs excluded from the randomized trial NCT00515970
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| Name | Affiliation | Role |
|---|---|---|
| Helmut Breuninger, M.D. | Eberhard Karls University Tuebingen, Department of Dermatology | Study Chair |
| Kay Brantsch, M.D. | Eberhard Karls University Tuebingen, Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eberhard Karls University, Department of Dermatology | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015580 | Mohs Surgery |
| ID | Term |
|---|---|
| D008866 | Microsurgery |
| D013514 | Surgical Procedures, Operative |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
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Paraffinized histology blocks and sections.
|
|
| Shave excision | Procedure | 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). |
|
| 12 and 48 months after surgery |
| D018295 |
| Neoplasms, Basal Cell |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |