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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric surgery | Procedure | Roux-and-Y Gastric Bypass or Sleeve gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution rate of baseline comorbidities associated with morbid obesity | comorbidities resolution rate will be expressed in % | 1 year after bariatric surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution rate in baseline comorbidities associated with morbid obesity | comorbidities resolution rate will be expressed in % | 5 years after bariatric surgery |
| Incidence of treatment-emergent adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henri Steyaert, MD-PhD | Contact | +3224773197 | henri.steyaert@huderf.be | |
| Helena Reusens, MD | Contact | +3224773197 | helena.reusens@huderf.be |
| Name | Affiliation | Role |
|---|---|---|
| Henri Steyaert, MD-PhD | Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint Pierre | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
| 30 days after bariatric surgery |
| Incidence of treatment-emergent adverse event | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 1 year after bariatric surgery |
| Incidence of treatment-emergent adverse event | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 5 years after bariatric surgery |
| Overall mortality rate | Overall mortality rate will be expressed in % | 30 days after bariatric surgery |
| Overall mortality rate | Overall mortality rate will be expressed in % | 1 year after bariatric surgery |
| Overall mortality rate | Overall mortality rate will be expressed in % | 5 years after bariatric surgery |
| Change from baseline in vitamin deficiencies | Change in vitamin deficiencies will be expressed in % | 1 year after bariatric surgery |
| Change from baseline in vitamin deficiencies | Change in vitamin deficiencies will be expressed in % | 5 years after bariatric surgery |
| Change from baseline in mineral deficiencies | Change in mineral deficiencies will be expressed in % | 1 year after bariatric surgery |
| Change from baseline in mineral deficiencies | Change in mineral deficiencies will be expressed in % | 5 years after bariatric surgery |
| Weight loss | weight loss will be reported in kg | 1 year after bariatric surgery |
| Weight loss | weight loss will be reported in kg | 5 years after bariatric surgery |
| Reduction in BMI | BMI will be reported in kg/m^2 | 1 year after bariatric surgery |
| Reduction in BMI | BMI will be reported in kg/m^2 | 5 years after bariatric surgery |
| Change from baseline in body mass composition | Change in Fat Mass and Lean Body Mass will be reported in kg | 2 years after bariatric surgery |
| Change from baseline in body mass composition | Change in Fat Mass and Lean Body Mass will be reported in kg | 5 years after bariatric surgery |
| Change from baseline in Eating behaviors after bariatric surgery | Change in Eating Behaviors behaviors will be assessed by Dutch Eating Behaviour Questionnaire (DEBQ) and will be reported in units on a scale | 1 year after bariatric surgery |
| Change from baseline in Eating behaviors after bariatric surgery | Change in Eating Behaviors behaviors will be assessed by DEBQ questionnaire and will be reported in units on a scale | 2 years after bariatric surgery |
| Change from baseline in Eating behaviors after bariatric surgery | Change in Eating Behaviors behaviors will be assessed by DEBQ questionnaire and will be reported in units on a scale | 5 years after bariatric surgery |
| Change from baseline in quality of life after bariatric surgery | Change in Quality of Life will be assessed by PedsQL questionnaire and will be reported in units on a scale | 1 year after bariatric surgery |
| Change from baseline in quality of life after bariatric surgery | Change in Quality of Life will be assessed by PedsQL questionnaire and will be reported in units on a scale | 2 years after bariatric surgery |
| Change from baseline in quality of life after bariatric surgery | Change in Quality of Life will be assessed by PedsQL questionnaire (units on a scale) | 5 years after bariatric surgery |
| Hôpital Universitaire Des Enfants Reine Fabiola | Brussels | 1020 | Belgium |
|
| Universitair Ziekenhuis Brussel (UZB) | Brussels | 1090 | Belgium |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |