Registry on Obesity Surgery in Adolescents

NCT03203161 | Not Yet Recruiting

• 1 other identifier: P2017/CHIR/ROSA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Morbid Obesity; Bariatric Surgery; Adolescent Obesity

Outcome Measures

Primary Outcomes (1)

• Resolution rate of baseline comorbidities associated with morbid obesity

  comorbidities resolution rate will be expressed in %

  1 year after bariatric surgery

Secondary Outcomes (23)

• Resolution rate in baseline comorbidities associated with morbid obesity

  5 years after bariatric surgery

• Incidence of treatment-emergent adverse event

  30 days after bariatric surgery

• Incidence of treatment-emergent adverse event

  1 year after bariatric surgery

• Incidence of treatment-emergent adverse event

  5 years after bariatric surgery

• Overall mortality rate

  30 days after bariatric surgery

Interventions

bariatric surgery PROCEDURE

Roux-and-Y Gastric Bypass or Sleeve gastrectomy

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead

Study Sites (3)

CHU Saint Pierre

Brussels, 1000, Belgium

Location

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Universitair Ziekenhuis Brussel (UZB)

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Obesity, Morbid; Pediatric Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Henri Steyaert, MD-PhD

  Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henri Steyaert, MD-PhD

CONTACT

+3224773197; henri.steyaert@huderf.be

Helena Reusens, MD

CONTACT

+3224773197; helena.reusens@huderf.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 29, 2017
• Study Start: September 1, 2019
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)