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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT02280889

Studienbeginn:
Mai 2013

Letztes Update:
16.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Nevus, Nevus, Pigmented

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
University Children's Hospital, Zurich

Collaborator:
-

Studienleiter

Kathrin Neuhaus, MD
Principal Investigator
University Children's Hospital, Zurich

Kontakt

Kathrin Neuhaus, MD
Kontakt:
Phone: +41442668154
E-Mail: kathrin.neuhaus@kispi.uzh.ch» Kontaktdaten anzeigen

Markus Landolt, Prof
Kontakt:
Phone: +41442667111
E-Mail: markus.landolt@kispi.uzh.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery
8032 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Kathrin Neuhaus, MD
Phone: +41442667111
E-Mail: kathrin.neuhaus@kispi.uzh.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Change of Quality of Life of affected children before and after surgery (Time Frame - 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 outcome:

1. Change of experiences of stigmatization before and after surgery (Time Frame - 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

2. Satisfaction with the treatment (Time Frame - One year after surgery):
Satisfaction with the treatment is evaluated one year after the last surgical step using open questions with rating scales

Quelle: ClinicalTrials.gov

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