- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203161
Registry on Obesity Surgery in Adolescents (ROSA)
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
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Henri Steyaert, MD-PhD
- Phone Number: +3224773197
- Email: henri.steyaert@huderf.be
Study Contact Backup
- Name: Helena Reusens, MD
- Phone Number: +3224773197
- Email: helena.reusens@huderf.be
Study Locations
-
-
-
Brussels, Belgium, 1020
- Hôpital Universitaire des Enfants Reine Fabiola
-
Contact:
- Helena Reusens, MD
- Phone Number: +3224773197
- Email: helena.reusens@huderf.be
-
Principal Investigator:
- Henri Steyaert, MD-PhD
-
Brussels, Belgium, 1000
- CHU Saint Pierre
-
Contact:
- Guy-Bernard Cadière, MD-PhD
- Phone Number: +3225354115
- Email: guy_cadiere@stpierre-bru.be
-
Principal Investigator:
- Guy-Bernard Cadière, Md-PhD
-
Brussels, Belgium, 1090
- Universitair Ziekenhuis Brussel (UZB)
-
Contact:
- Inge Gies, MD-PhD
- Phone Number: +3224774180
- Email: Inge.Gies@uzbrussel.be
-
Principal Investigator:
- Inge Gies, MD-PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- Principal Investigator: Henri Steyaert, MD-PhD, Hopital Universitaire des Enfants Reine Fabiola (HUDERF)
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2017/CHIR/ROSA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Morbid Obesity
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Rijnstate HospitalRecruiting
-
Laval UniversityCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie...Recruiting
-
University of WashingtonUnited States Department of DefenseWithdrawn
-
Helsinki University Central HospitalActive, not recruiting
-
IHU StrasbourgWithdrawnMorbid Obesity
Clinical Trials on bariatric surgery
-
Centre Hospitalier Universitaire de NiceTerminatedObesity | Chronic Kidney DiseaseFrance
-
Imperial College LondonRecruitingObesity | Type 2 DiabetesIreland
-
McMaster UniversityNot yet recruitingRobotic Surgery | Bariatric Surgery
-
Vanderbilt University Medical CenterNational Cancer Institute (NCI); National Institute of Diabetes and Digestive...RecruitingCardiovascular Diseases | Hypertension | Dyslipidemias | Type 2 Diabetes | Morbid Obesity | Bariatric Surgery CandidateUnited States
-
Guy's and St Thomas' NHS Foundation TrustRecruitingObesity Hypoventilation Syndrome (OHS)United Kingdom
-
Rabin Medical CenterRecruiting
-
V.K.V. American Hospital, IstanbulCompletedBariatric Surgery Candidate | Post Operative Pain | Regional Anesthesia MorbidityTurkey
-
Hacettepe UniversityCompleted
-
University of California, Los AngelesCompletedObesity | Bariatric Surgery Candidate