What is the study about? This study aims to improve the success rate of removal surgery for a common type of skin cancer. We will compare two different methods of marking (drawing where to remove) the skin before removing the lump: the normal method using magnifying glasses and theatre lights, and our proposed method using a handheld magnifying device called a dermatoscope.
Why is this study important? Skin cancer is the most common cancer in the UK. Currently, up to 10-11% of surgeries do not remove all of the cancer, which means patients may need more treatment. We do not know whether using a dermatoscope can help surgeons remove all of the cancer more often or not. If it does, it could prevent patients needing more surgery or time in hospital.
What will happen during the study? A computer will randomly allocate each participant to marking using the normal method, or using a dermatoscope. The surgery will then proceed as usual. After the surgery, patients will be asked to fill in a simple questionnaire about their thoughts. We will collect data from patients' notes to monitor the success of the surgery and any more treatments needed.
What will we measure? We will check participants records to see if the cancer was entirely removed. This is reported by a pathologist whenever a skin lump or bump is removed. In time, we will also look at 5-year recurrence of cancer, the need for additional treatments, any problems from the marking process, how happy patients are with the process, and the time it takes to perform the marking.
What is the pilot for? The study will need many hundreds of patients to pick up a meaningful result. Before we commit to recruiting this many people, we want to make sure that the way we run the study is acceptable. This means looking at the number of people we recruit each week, how easy it is to collect their data after their operation, and whether there are any areas that we can't use a dermatoscope, such as the curves around the eye, nose and ears. We will run the study in a smaller number of people (around 200) before deciding whether we can commit to recruiting everyone. This will also give us the chance to see whether we can run the study in more than one hospital.
Adults aged 18 years or older who are scheduled for the excision of a suspected non-melanoma skin cancer lesion as part of a day-case surgery list at Hull University Teaching Hospitals are eligible for inclusion in the study.
Lesions that are inaccessible to dermoscopic assessment due to anatomical locations or conditions that prevent effective use of the dermatoscope.
Lesions that are determined to be benign or pigmented upon initial evaluation and therefore do not meet the criteria for suspected keratinocyte skin cancer.
Lesions scheduled for incisional, punch, or shave biopsy procedures, as these methods do not provide complete peripheral margin clearance.
Lesions that are histologically confirmed as benign following excision and examination by a pathologist.
Parallel
Dermatoscope
DeviceFor participants in the dermoscopy group, the marking will also be done preoperatively with a marker pen, but the lesion borders will be determined using a dermatoscope. A peripheral margin based on BAD guidelines will be marked similarly.
Excision completeness at the lateral margin
The primary outcome will assess the completeness of excision at the peripheral margin, confirmed by histological examination of the skin lesion, for patients undergoing excision biopsy of suspected keratinocyte skin cancer. As dermoscopy can only assess up to the depth of the reticular dermis, the completeness of excision at the deep margin will not be evaluated in this study.
5 Year Recurrence Rate
We will measure recurrence of the skin lesion within 5 years of lesion excision
5 Year additional treatment rate
We will measure additional treatment for the index lesion within 5 years of lesion excision - this includes wider surgical excision, radiotherapy, cryotherapy, electrochemotherapy, and immunotherapy
Adverse Events relating to lesion marking
We will collect data on adverse events relating only to the lesion marking procedure
Patient acceptability and satisfaction
We will measure patient satisfaction on a 1-10 visual analogue scale, with 1 being completely unacceptable and 10 being completely acceptable
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