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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Stigmatization

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Kathrin Neuhaus, MD; Phone Number: +41442668154; Email: kathrin.neuhaus@kispi.uzh.ch
• Study Contact Backup: Name: Markus Landolt, Prof; Phone Number: +41442667111; Email: markus.landolt@kispi.uzh.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Recruiting
    • University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery
    • Contact: Kathrin Neuhaus, MD; Phone Number: +41442667111; Email: kathrin.neuhaus@kispi.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 16 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Kathrin Neuhaus, MD, University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Anticipated): December 1, 2031
• Study Completion (Anticipated): December 1, 2031

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; scar; stigmatization; nevus or scar
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus; Nevus, Pigmented
• Other Study ID Numbers: 2013-0242; PB_2019-00139 (Other Identifier: EC Zurich)