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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Basal Cell
• Intervention / Treatment: Procedure: 3D-histology; Procedure: Shave excision

Detailed Description

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 Consent withdrawn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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Eberhard Karls University, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

BCCs excluded from the randomized trial NCT00515970

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1. 3D-histology; Nodular, micronodular, or sclerosing BCCs	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.; Other Names: Micrographic surgery; Histographic surgery; Mohs surgery
2. Shave excision; Superficial BCCs	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence of basal cell carcinoma (BCC)	Within 4 years after surgery

Secondary Outcome Measures

Outcome Measure	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.	12 and 48 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Study Chair: Helmut Breuninger, M.D., Eberhard Karls University Tuebingen, Department of Dermatology; Principal Investigator: Kay Brantsch, M.D., Eberhard Karls University Tuebingen, Department of Dermatology

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 14, 2008
• First Submitted That Met QC Criteria: March 14, 2008
• First Posted (Estimate): March 20, 2008

Study Record Updates

• Last Update Posted (Estimate): March 20, 2008
• Last Update Submitted That Met QC Criteria: March 14, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Recurrence; Mohs surgery; Carcinoma, Basal Cell; 3D-histology; Micrographic surgery; Shave excision; Esthetic outcome
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Basal Cell; Carcinoma; Recurrence; Carcinoma, Basal Cell
• Other Study ID Numbers: 16/2008BO2