A Prospective Observational Cohort Study Collecting Coordinated Clinical, Epidemiological, and Behavioural Data to Assess Safety and Efficacy of Surgical Treatment in Adolescent Morbid Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Resolution rate of baseline comorbidities associated with morbid obesity
研究概览
简要总结
While bariatric surgery is established as a safe and effective alternative with well-defined risks for severely obese adults, little has been published on its use in children.
There are many unresolved questions concerning the long-term metabolic and psychological consequences of bariatric surgery in adolescents, and the difference with the adult population. The appropriate timing for bariatric surgery in young people, and the predictors of success and safety still need to be determined.
The aim of this long-term prospective study is therefore to establish the safety and efficacy profile of surgical procedures and to clarify whether reductions in morbidity and mortality outweigh the risks of serious surgical complications and lifelong nutritional deficiencies.
详细描述
The investigators will conduct a prospective observational cohort design study to collect data during standard clinical care of adolescent bariatric patients (younger than 18 years) who were operated (RYGB or SG) for weight loss.
Medical, psychological, behavioral, fitness and social data will be collected by medical personnel guided by checklists and prepared questionnaires. All non-invasive and invasive examinations will be performed following the existing protocol of the multidisciplinary group at the hospital (no alteration of normal standard care). Data regarding family environment (birthdays, weight, length, medication, comorbidities, smoking and education of parents and siblings) will also be obtained from caregivers of the patients.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI (or projected BMI) > 40 kg/m² (projected BMI = weight over the age- and gender-specific BMI z-score defined as severe obesity corresponding at a projected BMI of 40 at the age of 18y) OR
- •BMI ((or projected BMI) > 35 kg/m² (projected BMI = weight over the age- and gender-specific BMI z-score defined as severe obesity corresponding at a projected BMI of 35 at the age of 18y) + 1 or more of the following obesity-related comorbid conditions: Obstructive Sleep Apnea Syndrome, Non-alcoholic steatohepatitis, type 2 diabetes, hypertension, benign intracranial hypertension.
- •Minimum 6 months of organized weight loss attempts before surgery (multidisciplinary follow-up)
- •Completed most of their linear growth (Tanner stage ≥ IV, bone age ≥ 13 years in girls and ≥ 14 years in boys assessed by the Tanner and Whitehouse method)
- •Capability and willingness to adhere to postoperative guidelines and prolonged surveillance
- •Informed Consent Form (ICF) signed by patient and parents (or legal guardian)
排除标准
- •psychological/psychiatric disorders that are decompensated or not efficiently treated
- •severe and unstable eating disorders (e.g. binge-eating)
- •signs of addictions or addictive behavior (alcohol or substance abuse)
- •pregnancy or breastfeeding
- •life-threatening multisystem organ failure
- •uncontrolled or metastatic malignancy
- •uncontrolled HIV infection
- •hypercarbic respiratory failure
- •active systemic infection or untreated endocrine dysfunction
- •diseases threatening in the short term or lack of care (self-care or access to family or social support)
- •medically correctable causes of obesity
结局指标
主要结局
Resolution rate of baseline comorbidities associated with morbid obesity
时间窗: 1 year after bariatric surgery
comorbidities resolution rate will be expressed in %
次要结局
- Incidence of treatment-emergent adverse event(5 years after bariatric surgery)
- Resolution rate in baseline comorbidities associated with morbid obesity(5 years after bariatric surgery)
- Overall mortality rate(5 years after bariatric surgery)
- Change from baseline in vitamin deficiencies(5 years after bariatric surgery)
- Change from baseline in mineral deficiencies(5 years after bariatric surgery)
- Weight loss(5 years after bariatric surgery)
- Reduction in BMI(5 years after bariatric surgery)
- Change from baseline in body mass composition(5 years after bariatric surgery)
- Change from baseline in Eating behaviors after bariatric surgery(5 years after bariatric surgery)
- Change from baseline in quality of life after bariatric surgery(5 years after bariatric surgery)