Registry on Obesity Surgery in Adolescents
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorQueen Fabiola Children's University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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.
Minimum 6 months of organized weight loss attempts before surgery (multidisciplinary follow-up)
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)
Disqualifiers
psychological/psychiatric disorders that are decompensated or not efficiently treated
severe and unstable eating disorders (e.g. binge-eating)
signs of addictions or addictive behavior (alcohol or substance abuse)
pregnancy or breastfeeding
Trial population
primary care clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
bariatric surgery
Procedure/SurgeryRoux-and-Y Gastric Bypass or Sleeve gastrectomy
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Resolution rate of baseline comorbidities associated with morbid obesity
comorbidities resolution rate will be expressed in %
Time frame
1 year after bariatric surgerySecondary outcomes
1
Resolution rate in baseline comorbidities associated with morbid obesity
comorbidities resolution rate will be expressed in %
Time frame
5 years after bariatric surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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