Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
| Stigmatization | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- 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 outcomes (2)
- measure
- Change of experiences of stigmatization before and after surgery
- timeFrame
- Before surgery, up to 90 days after screening and one year after surgery
- description
- Stigmatization experiences of patients and parents before CMN surgery in comparison with after nevus excision are measured using standardized and validated questionnaires
- measure
- Satisfaction with the treatment
- timeFrame
- One year after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Months
- Maximum age
- 16 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available