Registry on Obesity Surgery in Adolescents

Launched by QUEEN FABIOLA CHILDREN'S UNIVERSITY HOSPITAL · Jun 28, 2017

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the safety and effectiveness of bariatric surgery (weight-loss surgery) for adolescents with severe obesity. While we know that this type of surgery works well for adults, there is still much to learn about how it affects younger patients in the long term, especially regarding their physical health and mental well-being. The study aims to explore when is the best time for adolescents to undergo surgery, what factors contribute to successful outcomes, and whether the benefits of surgery outweigh the potential risks, such as serious complications or nutritional deficiencies that may arise after the procedure.

To be eligible for this study, participants must be adolescents who have a body mass index (BMI) greater than 40, or greater than 35 with additional health issues like type 2 diabetes or sleep apnea. They should have tried organized weight loss methods for at least six months and have mostly completed their growth. It's important that they can follow the guidelines after surgery and have support from their parents or guardians. The trial is not yet recruiting participants, but if chosen, participants will be closely monitored to assess their health and progress after the surgery.

Gender

ALL

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