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Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970

NCT ID: NCT00639652

Last Updated: 2008-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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1. Disinfection
2. Local anesthesia
3. Surgery
4. Dressing
5. Preparation with paraffin for histopathologic evaluation
6. Staining with hematoxylin-eosin
7. Adjuvant radiotherapy is not applied in any of our patients.
8. If histopathology discovers another tumor than BCC, the tumor is excluded.
9. If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
10. Patients who provide no feedback receive phone calls.
11. 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.
12. The letter contains a questionnaire about suspicion of recurrence of BCC.
13. The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
14. The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
15. When follow-up is closed for an individual patient, the reason is recorded:

1. Planned end of follow-up after 48 months
2. Patient has moved.
3. Death (date of death)
4. Consent withdrawn
5. Meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned.
6. Recurrence of all of the patient's BCCs with histopathologic confirmation.

Conditions

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Carcinoma, Basal Cell

Keywords

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Carcinoma, Basal Cell 3D-histology Micrographic surgery Mohs surgery Shave excision Recurrence Esthetic outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1. 3D-histology

Nodular, micronodular, or sclerosing BCCs

3D-histology

Intervention Type 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.

2. Shave excision

Superficial BCCs

Shave excision

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Other Intervention Names

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Micrographic surgery Histographic surgery Mohs surgery

Eligibility Criteria

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Inclusion Criteria

* BCCs excluded from the randomized trial NCT00515970

Exclusion Criteria

* Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Department of Dermatology, Eberhard Karls University

Principal Investigators

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Helmut Breuninger, M.D.

Role: STUDY_CHAIR

Eberhard Karls University Tuebingen, Department of Dermatology

Kay Brantsch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eberhard Karls University Tuebingen, Department of Dermatology

Locations

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Eberhard Karls University, Department of Dermatology

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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16/2008BO2

Identifier Type: -

Identifier Source: org_study_id