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

NCT02280889 | Recruiting

• 2 other identifiers: 2013-0242PB_2019-00139
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Stigmatization

Keywords

quality of life; nevus or scar; stigmatization; scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of experiences of stigmatization before and after surgery

  Before surgery, up to 90 days after screening and one year after surgery

• Satisfaction with the treatment

  One year after surgery

Eligibility Criteria

• Age: 9 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients with CMN of at least 2 square centimeter (projected adult size) that are scheduled for surgical removal of the CMN at our tertiary center for pediatric surgery.

You may qualify if:

• patients with a congenital melanocytic nevi of at least 2 cm2 that will be removed surgically
• age between 9 months and 16 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

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

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Stereotyping; Nevus; Cicatrix

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathrin Neuhaus, MD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Neuhaus, MD

CONTACT

+41442497466; kathrin.neuhaus@kispi.uzh.ch

Markus Landolt, Prof

CONTACT

+41442496388; markus.landolt@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: November 3, 2014
• Study Start: May 1, 2013
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CH (1)