Clinical trial NCT03203161: Registry on Obesity Surgery in Adolescents
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Morbid Obesity
Bariatric Surgery
Adolescent Obesity
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)
* Capability and willingness to adhere to postoperative guidelines and prolonged surveillance
* Informed Consent Form (ICF) signed by patient and parents (or legal guardian)

Exclusion Criteria:

* 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
* life-threatening multisystem organ failure
* uncontrolled or metastatic malignancy
* uncontrolled HIV infection
* hypercarbic respiratory failure
* active systemic infection or untreated endocrine dysfunction
* diseases threatening in the short term or lack of care (self-care or access to family or social support)
* medically correctable causes of obesity

Primary outcomes:
measure: Resolution rate of baseline comorbidities associated with morbid obesity
timeFrame: 1 year after bariatric surgery
Secondary outcomes:
measure: Resolution rate in baseline comorbidities associated with morbid obesity
timeFrame: 5 years after bariatric surgery
measure: Incidence of treatment-emergent adverse event
timeFrame: 30 days after bariatric surgery
measure: Incidence of treatment-emergent adverse event
timeFrame: 1 year after bariatric surgery
measure: Incidence of treatment-emergent adverse event
timeFrame: 5 years after bariatric surgery
measure: Overall mortality rate
timeFrame: 30 days after bariatric surgery
measure: Overall mortality rate
timeFrame: 1 year after bariatric surgery
measure: Overall mortality rate
timeFrame: 5 years after bariatric surgery
measure: Change from baseline in vitamin deficiencies
timeFrame: 1 year after bariatric surgery
measure: Change from baseline in vitamin deficiencies
timeFrame: 5 years after bariatric surgery
measure: Change from baseline in mineral deficiencies
timeFrame: 1 year after bariatric surgery
measure: Change from baseline in mineral deficiencies
timeFrame: 5 years after bariatric surgery
measure: Weight loss
timeFrame: 1 year after bariatric surgery
measure: Weight loss
timeFrame: 5 years after bariatric surgery
measure: Reduction in BMI
timeFrame: 1 year after bariatric surgery
measure: Reduction in BMI
timeFrame: 5 years after bariatric surgery
measure: Change from baseline in body mass composition
timeFrame: 2 years after bariatric surgery
measure: Change from baseline in body mass composition
timeFrame: 5 years after bariatric surgery
measure: Change from baseline in Eating behaviors after bariatric surgery
timeFrame: 1 year after bariatric surgery
measure: Change from baseline in Eating behaviors after bariatric surgery
timeFrame: 2 years after bariatric surgery
measure: Change from baseline in Eating behaviors after bariatric surgery
timeFrame: 5 years after bariatric surgery
measure: Change from baseline in quality of life after bariatric surgery
timeFrame: 1 year after bariatric surgery
measure: Change from baseline in quality of life after bariatric surgery
timeFrame: 2 years after bariatric surgery
measure: Change from baseline in quality of life after bariatric surgery
timeFrame: 5 years after bariatric surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel (UZB)
Study officials:
affiliation: Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF)
name: Henri Steyaert, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: