Evaluation of Potential Regret Related to Pediatric Surgical and Medical Management of Congenital Adrenal Hyperplasia, and Analysis of Long-term Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Regret related to pediatric management
研究概览
简要总结
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a chronic endocrine disorder, often diagnosed in the neonatal period. Severe forms may lead to genital virilization in afected girls and adrenal crises. Management includes lifelong hormone replacement therapy and, historically, early genital surgery, although recent guidelines recommend delaying non-urgent procedures to preserve patient autonomy.This study hypothesizes that pediatric management, particularly early surgical interventions, may influence long-term satisfaction and the expression of regret in adulthood. We will conduct an observational cross-sectional study including adult patients diagnosed with CAH during childhood. Data will be collected using standardized questionnaires assessing medical regret, quality of life, sexual function, and psychological outcomes, together with clinical characteristics and past medical and surgical history.The primary outcome is the prevalence of regret related to pediatric care. Secondary outcomes include quality of life, sexual satisfaction, psychological status, and adaptation of hormonal therapy from adolescence to adulthood. Patient-reported outcomes (regret, quality of life, sexual function, and psychological outcomes) will be assessed in female participants only, male participants will be included for the evaluation of hormonal treatment adaptation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older
- •Diagnosis of classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency
- •Followed at Lille University Hospital
- •Able to understand the study information and complete the questionnaires in French
- •Having provided written informed consent
排除标准
- •Patients younger than 18 years
- •Non-classic forms of congenital adrenal hyperplasia
- •Inability to understand the study information or to complete the questionnaires
- •Refusal to participate or lack of informed consent
- •Severe cognitive impairment or psychiatric condition preventing reliable questionnaire completion
结局指标
主要结局
Regret related to pediatric management
时间窗: At study inclusion (baseline)
Regret related to pediatric management assessed by the Decision Regret Scale (DRS)
次要结局
- Quality of life(at study inclusion (baseline))
- Sexual function(at study inclusion (baseline))
- Symptoms of anxiety and depression(at study inclusion)
- Adaptation of hormonal treatment from adolescence to adulthood(at study inclusion (baseline))
