Quality of Life and Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision

Study Overview
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Brief Summary
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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.

Detailed Description
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All children with CMN that will have their nevus removed in our surgical department will be asked to participate. The investigators will send a package of questionnaires to evaluate quality of life and stigmatization before nevus surgery. One year after surgical therapy is finished (sometimes more then one session is necessary), the scar will be clinically evaluated and also another questionnaire package will be sent to evaluate the same parameters again. All parameters are checked for the patients and the families as well. Therefore self and proxy reports of the parents are asked. Moreover, for the patients this is done with interviews in case they are older than 7 years.

Official Title
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Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study

Conditions
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Quality of Life, Stigmatization

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a congenital melanocytic nevi of at least 2 cm2 that will be removed surgically age between 9 months and 16 years Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Before surgery, up to 90 days after screening and one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Before surgery, up to 90 days after screening and one year after surgery | 
| Satisfaction with the treatment | Satisfaction with the treatment is evaluated one year after the last surgical step using open questions with rating scales | One year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, nevus or scar, stigmatization, scar