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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Quality of Life Stigmatization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

9 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No