Morbid Obesity Clinical Trial
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
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.
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.
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