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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-16
SponsorUniversity Children's Hospital, Zurich

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Before surgery, up to 90 days after screening and one year after surgery

Secondary outcomes

1

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

Time frame
Before surgery, up to 90 days after screening and one year after surgery
2

Satisfaction with the treatment

Satisfaction with the treatment is evaluated one year after the last surgical step using open questions with rating scales

Time frame
One year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.