NCT03203161Not yet recruiting
Registry on Obesity Surgery in Adolescents
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 22 Jun 2017
- Start date
- 1 Sept 2019
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Diseases
- Obesity
- NCT number
- NCT03203161
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Sept 2019 to the primary completion date, 30 Sept 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- signs of addictions or addictive behavior (alcohol or substance abuse)
- pregnancy or breastfeeding
- medically correctable causes of obesity
Who the study is looking for
- 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)
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Brussel (UZB) Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hòpital Universitaire des Enfants Reine Fabiola Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.