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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02280889
• Other study ID #: 2013-0242
• Secondary ID: PB_2019-00139
• Status: Recruiting
• Start date: May 2013
• Est. completion date: December 2031

Study information

• Verified date: May 2023
• Source: University Children's Hospital, Zurich
• Contact: Kathrin Neuhaus, MD
• Phone: +41442668154
• Email: kathrin.neuhaus[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nevus
• Nevus, Pigmented
• Quality of Life
• Stigmatization

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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