ROSA: Registry on Obesity Surgery in Adolescents
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Resolution rate of baseline comorbidities associated with morbid obesity [1 year after bariatric surgery]
comorbidities resolution rate will be expressed in %
Secondary Outcome Measures
- Resolution rate in baseline comorbidities associated with morbid obesity [5 years after bariatric surgery]
comorbidities resolution rate will be expressed in %
- Incidence of treatment-emergent adverse event [30 days after bariatric surgery]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Incidence of treatment-emergent adverse event [1 year after bariatric surgery]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Incidence of treatment-emergent adverse event [5 years after bariatric surgery]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Overall mortality rate [30 days after bariatric surgery]
Overall mortality rate will be expressed in %
- Overall mortality rate [1 year after bariatric surgery]
Overall mortality rate will be expressed in %
- Overall mortality rate [5 years after bariatric surgery]
Overall mortality rate will be expressed in %
- Change from baseline in vitamin deficiencies [1 year after bariatric surgery]
Change in vitamin deficiencies will be expressed in %
- Change from baseline in vitamin deficiencies [5 years after bariatric surgery]
Change in vitamin deficiencies will be expressed in %
- Change from baseline in mineral deficiencies [1 year after bariatric surgery]
Change in mineral deficiencies will be expressed in %
- Change from baseline in mineral deficiencies [5 years after bariatric surgery]
Change in mineral deficiencies will be expressed in %
- Weight loss [1 year after bariatric surgery]
weight loss will be reported in kg
- Weight loss [5 years after bariatric surgery]
weight loss will be reported in kg
- Reduction in BMI [1 year after bariatric surgery]
BMI will be reported in kg/m^2
- Reduction in BMI [5 years after bariatric surgery]
BMI will be reported in kg/m^2
- Change from baseline in body mass composition [2 years after bariatric surgery]
Change in Fat Mass and Lean Body Mass will be reported in kg
- Change from baseline in body mass composition [5 years after bariatric surgery]
Change in Fat Mass and Lean Body Mass will be reported in kg
- Change from baseline in Eating behaviors after bariatric surgery [1 year 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
- Change from baseline in Eating behaviors after bariatric surgery [2 years after bariatric surgery]
Change in Eating Behaviors behaviors will be assessed by DEBQ questionnaire and will be reported in units on a scale
- Change from baseline in Eating behaviors after bariatric surgery [5 years after bariatric surgery]
Change in Eating Behaviors behaviors will be assessed by DEBQ questionnaire and will be reported in units on a scale
- Change from baseline in quality of life after bariatric surgery [1 year after bariatric surgery]
Change in Quality of Life will be assessed by PedsQL questionnaire and will be reported in units on a scale
- Change from baseline in quality of life after bariatric surgery [2 years after bariatric surgery]
Change in Quality of Life will be assessed by PedsQL questionnaire and will be reported in units on a scale
- Change from baseline in quality of life after bariatric surgery [5 years after bariatric surgery]
Change in Quality of Life will be assessed by PedsQL questionnaire (units on a scale)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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.
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Minimum 6 months of organized weight loss attempts before surgery (multidisciplinary follow-up)
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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)
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Capability and willingness to adhere to postoperative guidelines and prolonged surveillance
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Informed Consent Form (ICF) signed by patient and parents (or legal guardian)
Exclusion Criteria:
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psychological/psychiatric disorders that are decompensated or not efficiently treated
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severe and unstable eating disorders (e.g. binge-eating)
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signs of addictions or addictive behavior (alcohol or substance abuse)
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pregnancy or breastfeeding
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life-threatening multisystem organ failure
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uncontrolled or metastatic malignancy
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uncontrolled HIV infection
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hypercarbic respiratory failure
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active systemic infection or untreated endocrine dysfunction
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diseases threatening in the short term or lack of care (self-care or access to family or social support)
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medically correctable causes of obesity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Saint Pierre | Brussels | Belgium | 1000 | |
| 2 | Hôpital Universitaire Des Enfants Reine Fabiola | Brussels | Belgium | 1020 | |
| 3 | Universitair Ziekenhuis Brussel (UZB) | Brussels | Belgium | 1090 |
Sponsors and Collaborators
- Queen Fabiola Children's University Hospital
Investigators
- Principal Investigator: Henri Steyaert, MD-PhD, Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P2017/CHIR/ROSA