Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Recurrence of basal cell carcinoma (BCC)
研究概览
简要总结
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.
详细描述
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Disinfection
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Local anesthesia
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Surgery
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Dressing
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Preparation with paraffin for histopathologic evaluation
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Staining with hematoxylin-eosin
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Adjuvant radiotherapy is not applied in any of our patients.
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If histopathology discovers another tumor than BCC, the tumor is excluded.
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If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
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Patients who provide no feedback receive phone calls.
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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.
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The letter contains a questionnaire about suspicion of recurrence of BCC.
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The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
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The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
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When follow-up is closed for an individual patient, the reason is recorded:
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Planned end of follow-up after 48 months
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Patient has moved.
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Death (date of death)
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Consent withdrawn
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Meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned.
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Recurrence of all of the patient's BCCs with histopathologic confirmation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCCs excluded from the randomized trial NCT00515970
排除标准
- •Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)
结局指标
主要结局
Recurrence of basal cell carcinoma (BCC)
时间窗: Within 4 years after surgery
次要结局
- 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.(12 and 48 months after surgery)