Registry on Obesity Surgery in Adolescents

Morbid Obesity Clinical Trial

— ROSA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03203161
• Other study ID #: P2017/CHIR/ROSA
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: September 2029

Study information

• Verified date: February 2019
• Source: Queen Fabiola Children's University Hospital
• Contact: Henri Steyaert, MD-PhD
• Phone: +3224773197
• Email: henri.steyaert[@]huderf.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Bariatric Surgery
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Pediatric Obesity

Intervention

Procedure:
• bariatric surgery
Roux-and-Y Gastric Bypass or Sleeve gastrectomy

Locations

Country	Name	City	State
Belgium	CHU Saint Pierre	Brussels
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels
Belgium	Universitair Ziekenhuis Brussel (UZB)	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution rate of baseline comorbidities associated with morbid obesity	comorbidities resolution rate will be expressed in %	1 year after bariatric surgery
Secondary	Resolution rate in baseline comorbidities associated with morbid obesity	comorbidities resolution rate will be expressed in %	5 years after bariatric surgery
Secondary	Incidence of treatment-emergent adverse event	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	30 days after bariatric surgery
Secondary	Incidence of treatment-emergent adverse event	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	1 year after bariatric surgery
Secondary	Incidence of treatment-emergent adverse event	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	5 years after bariatric surgery
Secondary	Overall mortality rate	Overall mortality rate will be expressed in %	30 days after bariatric surgery
Secondary	Overall mortality rate	Overall mortality rate will be expressed in %	1 year after bariatric surgery
Secondary	Overall mortality rate	Overall mortality rate will be expressed in %	5 years after bariatric surgery
Secondary	Change from baseline in vitamin deficiencies	Change in vitamin deficiencies will be expressed in %	1 year after bariatric surgery
Secondary	Change from baseline in vitamin deficiencies	Change in vitamin deficiencies will be expressed in %	5 years after bariatric surgery
Secondary	Change from baseline in mineral deficiencies	Change in mineral deficiencies will be expressed in %	1 year after bariatric surgery
Secondary	Change from baseline in mineral deficiencies	Change in mineral deficiencies will be expressed in %	5 years after bariatric surgery
Secondary	Weight loss	weight loss will be reported in kg	1 year after bariatric surgery
Secondary	Weight loss	weight loss will be reported in kg	5 years after bariatric surgery
Secondary	Reduction in BMI	BMI will be reported in kg/m^2	1 year after bariatric surgery
Secondary	Reduction in BMI	BMI will be reported in kg/m^2	5 years after bariatric surgery
Secondary	Change from baseline in body mass composition	Change in Fat Mass and Lean Body Mass will be reported in kg	2 years after bariatric surgery
Secondary	Change from baseline in body mass composition	Change in Fat Mass and Lean Body Mass will be reported in kg	5 years after bariatric surgery
Secondary	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	1 year after bariatric surgery
Secondary	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	2 years after bariatric surgery
Secondary	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	5 years after bariatric surgery
Secondary	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	1 year after bariatric surgery
Secondary	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	2 years after bariatric surgery
Secondary	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)	5 years after bariatric surgery