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NCT Number: NCT03203161

Registry on Obesity Surgery in Adolescents

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint Pierre, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Roux-and-Y Gastric Bypass or Sleeve gastrectomy

Primary outcomes

  1. Resolution rate of baseline comorbidities associated with morbid obesity

    Time frame: 1 year after bariatric surgery

    comorbidities resolution rate will be expressed in %

Secondary outcomes

  1. Resolution rate in baseline comorbidities associated with morbid obesity

    Time frame: 5 years after bariatric surgery

    comorbidities resolution rate will be expressed in %

  2. Incidence of treatment-emergent adverse event

    Time frame: 30 days after bariatric surgery

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  3. Incidence of treatment-emergent adverse event

    Time frame: 1 year after bariatric surgery

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  4. Incidence of treatment-emergent adverse event

    Time frame: 5 years after bariatric surgery

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  5. Overall mortality rate

    Time frame: 30 days after bariatric surgery

    Overall mortality rate will be expressed in %

  6. Overall mortality rate

    Time frame: 1 year after bariatric surgery

    Overall mortality rate will be expressed in %

  7. Overall mortality rate

    Time frame: 5 years after bariatric surgery

    Overall mortality rate will be expressed in %

  8. Change from baseline in vitamin deficiencies

    Time frame: 1 year after bariatric surgery

    Change in vitamin deficiencies will be expressed in %

  9. Change from baseline in vitamin deficiencies

    Time frame: 5 years after bariatric surgery

    Change in vitamin deficiencies will be expressed in %

  10. Change from baseline in mineral deficiencies

    Time frame: 1 year after bariatric surgery

    Change in mineral deficiencies will be expressed in %

  11. Change from baseline in mineral deficiencies

    Time frame: 5 years after bariatric surgery

    Change in mineral deficiencies will be expressed in %

  12. Weight loss

    Time frame: 1 year after bariatric surgery

    weight loss will be reported in kg

  13. Weight loss

    Time frame: 5 years after bariatric surgery

    weight loss will be reported in kg

  14. Reduction in BMI

    Time frame: 1 year after bariatric surgery

    BMI will be reported in kg/m^2

  15. Reduction in BMI

    Time frame: 5 years after bariatric surgery

    BMI will be reported in kg/m^2

  16. Change from baseline in body mass composition

    Time frame: 2 years after bariatric surgery

    Change in Fat Mass and Lean Body Mass will be reported in kg

  17. Change from baseline in body mass composition

    Time frame: 5 years after bariatric surgery

    Change in Fat Mass and Lean Body Mass will be reported in kg

  18. Change from baseline in Eating behaviors after bariatric surgery

    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

  19. Change from baseline in Eating behaviors after bariatric surgery

    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

  20. Change from baseline in Eating behaviors after bariatric surgery

    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

  21. Change from baseline in quality of life after bariatric surgery

    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

  22. Change from baseline in quality of life after bariatric surgery

    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

  23. Change from baseline in quality of life after bariatric surgery

    Time frame: 5 years after bariatric surgery

    Change in Quality of Life will be assessed by PedsQL questionnaire (units on a scale)

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Reusens, MD

CONTACT

[email protected]

+3224773197

Henri Steyaert, MD-PhD

CONTACT

[email protected]

+3224773197

Sponsors and collaborators

Lead sponsor

Queen Fabiola Children's University Hospital

Other

Registry information

Official study 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

Acronym: ROSA

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Jun 29, 2017
Registry last updated
Feb 12, 2019

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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