Dermatoscopy versus loupe magnification for determination of surgical margins during Modified Mohs*surgery of facial basal cell carcinoma

Dermatoscopy versus loupe magnification for determination of surgical margins during Modified Mohs*surgery of facial basal cell carcinoma - Dermatoscopy versus loupe magnification during Modified Mohs*surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45661

Enrollment

188

Registered

2017-03-15

Start date

2017-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

basal cell carcinoma basalioma skin cancer

Interventions

In the control group loupe magnification will be used for evaluation of the margins. In the intervention group the dermatoscope is used for evaluation of the margins .

Basal cell carcinoma

Dermascopy

Loupe magnification

Randomized trial

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Facial basal cell carcinoma which require reconstructive surgery

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Proportion of one stage radical excisions	—

Secondary

Measure	Time frame
Secondary objectives are to study: - the exact histologic margin, in millimetres, after final radical excision of the specimen in the intervention group and the control group. - the size of the defect, in millimetres, after excision in the intervention group and the control group. - the amount of re-excisions necessary to obtain surgical margins free of tumour cells in the intervention group and the control group. - duration of total procedure, in minutes, until reconstruction in the intervention group and the control group - total procedure time and medical costs for the intervention group and the control group - scar quality measured with the Patient and Observer Scar Assessment Scale (POSAS)20 after 6 weeks and 12 months - complications during the first 6 weeks after surgery such as infection, bleeding, wound dehiscence in both groups - sub-analysis of first time radical excision between both groups in the different histological types of facial basal cell carcinoma	—

Measure

Time frame

Secondary objectives are to study: - the exact histologic margin, in millimetres, after final radical excision of the specimen in the intervention group and the control group. - the size of the defect, in millimetres, after excision in the intervention group and the control group. - the amount of re-excisions necessary to obtain surgical margins free of tumour cells in the intervention group and the control group. - duration of total procedure, in minutes, until reconstruction in the intervention group and the control group - total procedure time and medical costs for the intervention group and the control group - scar quality measured with the Patient and Observer Scar Assessment Scale (POSAS)20 after 6 weeks and 12 months - complications during the first 6 weeks after surgery such as infection, bleeding, wound dehiscence in both groups - sub-analysis of first time radical excision between both groups in the different histological types of facial basal cell carcinoma

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)