Registry on Obesity Surgery in Adolescents

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура bariatric surgery
  Roux-and-Y Gastric Bypass or Sleeve gastrectomy

Первичные конечные точки

• Resolution rate of baseline comorbidities associated with morbid obesity [Срок оценки: 1 year after bariatric surgery]

Вторичные конечные точки (12)

• Resolution rate in baseline comorbidities associated with morbid obesity [Срок оценки: 5 years after bariatric surgery]
• Incidence of treatment-emergent adverse event [Срок оценки: 30 days after bariatric surgery]
• Incidence of treatment-emergent adverse event [Срок оценки: 1 year after bariatric surgery]
• Incidence of treatment-emergent adverse event [Срок оценки: 5 years after bariatric surgery]
• Overall mortality rate [Срок оценки: 30 days after bariatric surgery]
• Overall mortality rate [Срок оценки: 1 year after bariatric surgery]
• Overall mortality rate [Срок оценки: 5 years after bariatric surgery]
• Change from baseline in vitamin deficiencies [Срок оценки: 1 year after bariatric surgery]
• Change from baseline in vitamin deficiencies [Срок оценки: 5 years after bariatric surgery]
• Change from baseline in mineral deficiencies [Срок оценки: 1 year after bariatric surgery]
• Change from baseline in mineral deficiencies [Срок оценки: 5 years after bariatric surgery]
• Weight loss [Срок оценки: 1 year after bariatric surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 3 центра

• CHU Saint Pierre — Brussels
• Hôpital Universitaire Des Enfants Reine Fabiola — Brussels
• Universitair Ziekenhuis Brussel (UZB) — Brussels

Идентификаторы

NCT: NCT03203161 · P2017/CHIR/ROSA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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