Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Quality of Life of affected children before and after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a congenital melanocytic nevi of at least 2 cm2 that will be removed surgically
- •age between 9 months and 16 years
排除标准
- •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)
结局指标
主要结局
Change of Quality of Life of affected children before and after surgery
时间窗: 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
次要结局
- 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)