Morbid ObesityROSANCT03203161
Registry on Obesity Surgery in Adolescents
An observational study of Morbid Obesity and Bariatric Surgery, run by Queen Fabiola Children's University Hospital at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery, Adolescent Obesity
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 3 sitesBelgium
- Study dates
- Sep 2019to Sep 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: primary care clinic
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites
CHU Saint Pierre
Brussels, 1000
Guy-Bernard Cadière, MD-PhD, +3225354115, guy_cadiere@stpierre-bru.be
Guy-Bernard Cadière, Md-PhD
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Helena Reusens, MD, +3224773197, helena.reusens@huderf.be
Henri Steyaert, MD-PhD
Universitair Ziekenhuis Brussel (UZB)
Brussels, 1090
Inge Gies, MD-PhD, +3224774180, Inge.Gies@uzbrussel.be
Inge Gies, MD-PhD
About this study
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
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.
Read the 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.
- Conditions
- Morbid Obesity, Bariatric Surgery, Adolescent Obesity
- Being tested
- bariatric surgery
- Medical subject headings
- Obesity, Morbid, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
Roux-and-Y Gastric Bypass or Sleeve gastrectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution rate of baseline comorbidities associated with morbid obesity
comorbidities resolution rate will be expressed in %
Measured: 1 year after bariatric surgery
Secondary outcomes (23)
Resolution rate in baseline comorbidities associated with morbid obesity
comorbidities resolution rate will be expressed in %
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years after bariatric surgery
Overall mortality rate
Overall mortality rate will be expressed in %
Measured: 30 days after bariatric surgery
Overall mortality rate
Overall mortality rate will be expressed in %
Measured: 1 year after bariatric surgery
Overall mortality rate
Overall mortality rate will be expressed in %
Measured: 5 years after bariatric surgery
Change from baseline in vitamin deficiencies
Change in vitamin deficiencies will be expressed in %
Measured: 1 year after bariatric surgery
Change from baseline in vitamin deficiencies
Change in vitamin deficiencies will be expressed in %
Measured: 5 years after bariatric surgery
Change from baseline in mineral deficiencies
Change in mineral deficiencies will be expressed in %
Measured: 1 year after bariatric surgery
Change from baseline in mineral deficiencies
Change in mineral deficiencies will be expressed in %
Measured: 5 years after bariatric surgery
Weight loss
weight loss will be reported in kg
Measured: 1 year after bariatric surgery
Weight loss
weight loss will be reported in kg
Measured: 5 years after bariatric surgery
Reduction in BMI
BMI will be reported in kg/m^2
Measured: 1 year after bariatric surgery
Reduction in BMI
BMI will be reported in kg/m^2
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 5 years after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study startSep 2019 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri Steyaert, MD-PhD, Principal investigator, Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203161
- Sponsor's protocol ID
- P2017/CHIR/ROSA
- Acronym
- ROSA
- Status last verified
- Feb 2019
- First submitted
- 22 Jun 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No