About this trial
Congenital melanocytic nevi (CMN) are a quite common congenital disorder. Over years, surgical excision was proposed to the patients because transformation into a malignant skin tumor (melanoma) was feared. Recent data proof that the risk for malignancy was overestimated. Nowadays still a lot of patients express their wish for surgical removal out of aesthetic reasons and psychological impacts. Many patients and families experience stigmatization because of the nevus. To proof a medical indication for surgical removal the investigators want to evaluate the quality of life and stigmatization before and after nevus surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with a congenital melanocytic nevi of at least 2 cm2 that will be removed surgically
age between 9 months and 16 years
Disqualifiers
mental retardation of the child
insufficient knowledge of the German language of both parents
severe comorbidities
previous therapies done for the CMN (dermabrasion, surgery, laser)
Trial population
All patients with CMN of at least 2 square centimeter (projected adult size) that are scheduled for surgical removal of the CMN at our tertiary center for pediatric surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change of Quality of Life of affected children before and after surgery
Quality of life with the CMN and in comparison with the scar after nevus excision is measured using validated age-related questionnaires respectively one-to one interviews
Secondary outcomes
Change of experiences of stigmatization before and after surgery
Stigmatization experiences of patients and parents before CMN surgery in comparison with after nevus excision are measured using standardized and validated questionnaires
Satisfaction with the treatment
Satisfaction with the treatment is evaluated one year after the last surgical step using open questions with rating scales
Sponsors and contacts
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