bariatric surgery
ProcedureRoux-and-Y Gastric Bypass or Sleeve gastrectomy
NCT Number: NCT03203161
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.
Trial opening soon.
Get Notified12 year–17 year
All sexes
Observational
CHU Saint Pierre, Brussels, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Roux-and-Y Gastric Bypass or Sleeve gastrectomy
Time frame: 1 year after bariatric surgery
comorbidities resolution rate will be expressed in %
Time frame: 5 years after bariatric surgery
comorbidities resolution rate will be expressed in %
Time frame: 30 days after bariatric surgery
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 year after bariatric surgery
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 5 years after bariatric surgery
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 30 days after bariatric surgery
Overall mortality rate will be expressed in %
Time frame: 1 year after bariatric surgery
Overall mortality rate will be expressed in %
Time frame: 5 years after bariatric surgery
Overall mortality rate will be expressed in %
Time frame: 1 year after bariatric surgery
Change in vitamin deficiencies will be expressed in %
Time frame: 5 years after bariatric surgery
Change in vitamin deficiencies will be expressed in %
Time frame: 1 year after bariatric surgery
Change in mineral deficiencies will be expressed in %
Time frame: 5 years after bariatric surgery
Change in mineral deficiencies will be expressed in %
Time frame: 1 year after bariatric surgery
weight loss will be reported in kg
Time frame: 5 years after bariatric surgery
weight loss will be reported in kg
Time frame: 1 year after bariatric surgery
BMI will be reported in kg/m^2
Time frame: 5 years after bariatric surgery
BMI will be reported in kg/m^2
Time frame: 2 years after bariatric surgery
Change in Fat Mass and Lean Body Mass will be reported in kg
Time frame: 5 years after bariatric surgery
Change in Fat Mass and Lean Body Mass will be reported in kg
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years after bariatric surgery
Change in Quality of Life will be assessed by PedsQL questionnaire (units on a scale)
Contact information is provided by the study sponsor or research team.
Helena Reusens, MD
CONTACT
Henri Steyaert, MD-PhD
CONTACT
Queen Fabiola Children's University Hospital
Other
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
Acronym: ROSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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