Registry on Obesity Surgery in Adolescents (ROSA)

February 11, 2019 updated by: Queen Fabiola Children's University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola
        • Contact:
        • Principal Investigator:
          • Henri Steyaert, MD-PhD
      • Brussels, Belgium, 1000
        • CHU Saint Pierre
        • Contact:
        • Principal Investigator:
          • Guy-Bernard Cadière, Md-PhD
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel (UZB)
        • Contact:
        • Principal Investigator:
          • Inge Gies, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resolution rate of baseline comorbidities associated with morbid obesity
Time Frame: 1 year after bariatric surgery
comorbidities resolution rate will be expressed in %
1 year after bariatric surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resolution rate in baseline comorbidities associated with morbid obesity
Time Frame: 5 years after bariatric surgery
comorbidities resolution rate will be expressed in %
5 years after bariatric surgery
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
30 days after bariatric surgery
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
1 year after bariatric surgery
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 years after bariatric surgery
Overall mortality rate
Time Frame: 30 days after bariatric surgery
Overall mortality rate will be expressed in %
30 days after bariatric surgery
Overall mortality rate
Time Frame: 1 year after bariatric surgery
Overall mortality rate will be expressed in %
1 year after bariatric surgery
Overall mortality rate
Time Frame: 5 years after bariatric surgery
Overall mortality rate will be expressed in %
5 years after bariatric surgery
Change from baseline in vitamin deficiencies
Time Frame: 1 year after bariatric surgery
Change in vitamin deficiencies will be expressed in %
1 year after bariatric surgery
Change from baseline in vitamin deficiencies
Time Frame: 5 years after bariatric surgery
Change in vitamin deficiencies will be expressed in %
5 years after bariatric surgery
Change from baseline in mineral deficiencies
Time Frame: 1 year after bariatric surgery
Change in mineral deficiencies will be expressed in %
1 year after bariatric surgery
Change from baseline in mineral deficiencies
Time Frame: 5 years after bariatric surgery
Change in mineral deficiencies will be expressed in %
5 years after bariatric surgery
Weight loss
Time Frame: 1 year after bariatric surgery
weight loss will be reported in kg
1 year after bariatric surgery
Weight loss
Time Frame: 5 years after bariatric surgery
weight loss will be reported in kg
5 years after bariatric surgery
Reduction in BMI
Time Frame: 1 year after bariatric surgery
BMI will be reported in kg/m^2
1 year after bariatric surgery
Reduction in BMI
Time Frame: 5 years after bariatric surgery
BMI will be reported in kg/m^2
5 years after bariatric surgery
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
2 years after bariatric surgery
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
5 years after bariatric surgery
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
1 year after bariatric surgery
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
2 years after bariatric surgery
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
5 years after bariatric surgery
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
1 year after bariatric surgery
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
2 years after bariatric surgery
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)
5 years after bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Fabiola Children's University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henri Steyaert, MD-PhD, Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2029

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P2017/CHIR/ROSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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