Clinical trial NCT02280889: Quality of Life and Stigmatization in Children with Congenital Melanocytic Nevi Before and After Nevus Excision
Official title: Quality of Life and Experience of Stigmatization in Children with Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Stigmatization
Keywords: quality of life
nevus or scar
stigmatization
scar
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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)

Primary outcomes:
measure: Change of Quality of Life of affected children before and after surgery
timeFrame: Before surgery, up to 90 days after screening and one year after surgery
Secondary outcomes:
measure: Change of experiences of stigmatization before and after surgery
timeFrame: Before surgery, up to 90 days after screening and one year after surgery
measure: Satisfaction with the treatment
timeFrame: One year after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery
Study officials:
affiliation: University Children's Hospital, Zurich
name: Kathrin Neuhaus, MD
role: PRINCIPAL_INVESTIGATOR
References: