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

Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02280889

Enrollment

100

Registered

2014-11-03

Start date

2013-05-01

Completion date

2031-12-01

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Stigmatization

Keywords

quality of life, nevus or scar, stigmatization, scar

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to 16 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Change of Quality of Life of affected children before and after surgery	Before surgery, up to 90 days after screening and one year 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

Secondary

Measure	Time frame	Description
Change of experiences of stigmatization before and after surgery	Before surgery, up to 90 days after screening and one year after surgery	Stigmatization experiences of patients and parents before CMN surgery in comparison with after nevus excision are measured using standardized and validated questionnaires
Satisfaction with the treatment	One year after surgery	Satisfaction with the treatment is evaluated one year after the last surgical step using open questions with rating scales

Countries

Switzerland

Contacts

CONTACTKathrin Neuhaus, MD

kathrin.neuhaus@kispi.uzh.ch+41442497466

CONTACTMarkus Landolt, Prof

markus.landolt@kispi.uzh.ch+41442496388

PRINCIPAL_INVESTIGATORKathrin Neuhaus, MD

University Children's Hospital, Zurich

Outcome results