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NCT02280889 | RECRUITING | Quality of Life


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

University Children's Hospital, Zurich

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.

Condition or disease

Quality of Life

Stigmatization

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study
Actual Study Start Date : 2013-05
Estimated Primary Completion Date : 2031-12
Estimated Study Completion Date : 2031-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 9 Months to 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)

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

Location Details

NCT02280889


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How to Participate

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Locations


RECRUITING

Switzerland,

University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery

Zurich, Switzerland, 8008

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