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

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Enrolling

Conditions

Quality of Life
Stigmatization

Study type

Observational

Funder types

Other

Identifiers

NCT02280889
PB_2019-00139 (Other Identifier)
2013-0242

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

9 months to 16 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Central trial contact

Kathrin Neuhaus, MD; Markus Landolt, Prof

Data sourced from clinicaltrials.gov

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