Registry on Obesity Surgery in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bariatric surgery.
- Who it may be relevant to
- Registry conditions: Morbid Obesity, Bariatric Surgery, Adolescent Obesity. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Procedure bariatric surgery
Roux-and-Y Gastric Bypass or Sleeve gastrectomy
Primary outcome measures
- Resolution rate of baseline comorbidities associated with morbid obesity [Time frame: 1 year after bariatric surgery]
Secondary outcome measures (12)
- Resolution rate in baseline comorbidities associated with morbid obesity [Time frame: 5 years after bariatric surgery]
- Incidence of treatment-emergent adverse event [Time frame: 30 days after bariatric surgery]
- Incidence of treatment-emergent adverse event [Time frame: 1 year after bariatric surgery]
- Incidence of treatment-emergent adverse event [Time frame: 5 years after bariatric surgery]
- Overall mortality rate [Time frame: 30 days after bariatric surgery]
- Overall mortality rate [Time frame: 1 year after bariatric surgery]
- Overall mortality rate [Time frame: 5 years after bariatric surgery]
- Change from baseline in vitamin deficiencies [Time frame: 1 year after bariatric surgery]
- Change from baseline in vitamin deficiencies [Time frame: 5 years after bariatric surgery]
- Change from baseline in mineral deficiencies [Time frame: 1 year after bariatric surgery]
- Change from baseline in mineral deficiencies [Time frame: 5 years after bariatric surgery]
- Weight loss [Time frame: 1 year after bariatric surgery]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 3 centers
- CHU Saint Pierre — Brussels
- Hôpital Universitaire Des Enfants Reine Fabiola — Brussels
- Universitair Ziekenhuis Brussel (UZB) — Brussels
Identifiers
NCT: NCT03203161 · P2017/CHIR/ROSA