An observational study in Morbid Obesity, Bariatric Surgery and Adolescent Obesity, sponsored by Queen Fabiola Children's University Hospital. Not yet recruiting at 3 sites in Belgium. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Queen Fabiola Children's University Hospital · Observational
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
primary care clinic
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Roux-and-Y Gastric Bypass or Sleeve gastrectomy
Resolution rate of baseline comorbidities associated with morbid obesity
comorbidities resolution rate will be expressed in %
Time frame: 1 year after bariatric surgery
Resolution rate in baseline comorbidities associated with morbid obesity
comorbidities resolution rate will be expressed in %
Time frame: 5 years after bariatric surgery
Incidence of treatment-emergent adverse event
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 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
Time frame: 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
Time frame: 5 years after bariatric surgery
Overall mortality rate
Overall mortality rate will be expressed in %
Time frame: 30 days after bariatric surgery
Overall mortality rate
Overall mortality rate will be expressed in %
Time frame: 1 year after bariatric surgery
Overall mortality rate
Overall mortality rate will be expressed in %
Time frame: 5 years after bariatric surgery
Change from baseline in vitamin deficiencies
Change in vitamin deficiencies will be expressed in %
Time frame: 1 year after bariatric surgery
Change from baseline in vitamin deficiencies
Change in vitamin deficiencies will be expressed in %
Time frame: 5 years after bariatric surgery
Change from baseline in mineral deficiencies
Change in mineral deficiencies will be expressed in %
Time frame: 1 year after bariatric surgery
Change from baseline in mineral deficiencies
Change in mineral deficiencies will be expressed in %
Time frame: 5 years after bariatric surgery
Weight loss
weight loss will be reported in kg
Time frame: 1 year after bariatric surgery
Weight loss
weight loss will be reported in kg
Time frame: 5 years after bariatric surgery
Reduction in BMI
BMI will be reported in kg/m\^2
Time frame: 1 year after bariatric surgery
Reduction in BMI
BMI will be reported in kg/m\^2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 5 years after bariatric surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2019; primary completion for Sep 2029, 120 months later.
Of 137 non-industry observational studies under Obesity, Morbid, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 132. This study's planned 120 months is above that.
Counting every sponsor, half of 138 studies reached it within 46 months; a quarter within 16 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Queen Fabiola Children's University Hospital