Quality of Life and Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Quality of Life, Stigmatization. Basic parameters: 9 months — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study
Overview
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
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.
Primary outcome measures
- Change of Quality of Life of affected children before and after surgery [Time frame: Before surgery, up to 90 days after screening and one year after surgery]
Secondary outcome measures (2)
- Change of experiences of stigmatization before and after surgery [Time frame: Before surgery, up to 90 days after screening and one year after surgery]
- Satisfaction with the treatment [Time frame: One year after surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Su — Zurich
Identifiers
NCT: NCT02280889 · 2013-0242 · PB_2019-00139