Following adolescents with severe obesity who have bariatric surgery
Studies safety and results of weight-loss surgery in teenagers with severe obesity.
Plain-language title generated from the registry record
Registry title: Registry on Obesity Surgery in Adolescents
Key facts
- Where
- Brussels, BelgiumSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT03203161, who can take part
Where in Belgium
- CHU Saint-PierreBrussels, BelgiumNo longer taking part
- Hòpital Universitaire des Enfants Reine FabiolaBrussels, BelgiumNo longer taking part
- Universitair Ziekenhuis Brussel (UZB)Brussels, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Queen Fabiola Children's University Hospital
- Trial code
- NCT03203161
- Record updated
- 12 February 2019
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: psychological/psychiatric disorders that are decompensated or not efficiently treated; severe and unstable eating disorders (e.g. binge-eating); 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); signs of addictions or addictive behavior (alcohol or substance abuse); pregnancy or breastfeeding; medically correctable causes of obesity.