Obesitas fattness Obesity overweight severe obesity
Conditions
Interventions
The adolescents will either receive RYGB or SG, based on the preference of the
adolescent and the surgeon. Both procedures will be combined with a lifestyle
intervention program. The adolescents wit
Sponsors
Maxima Medisch Centrum
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: (i) Completed a minimum of twelve months in formal lifestyle intervention and/or pharmacotherapy weight loss program; (ii) Age 13-17 with Tanner stage >= IV; (iii) Severe obesity meeting IFSO criteria for bariatric surgery, BMI >=40 kg/m2 with minor comorbidities or BMI >=35 kg/m2 with at least one major comorbidity, corrected for age and sex according to the IOTF criteria; (iv) Consensus in the multidisciplinary child obesity team, during the multidisciplinary meeting, on a strongly motivated participation of the participant during the lifestyle intervention program so far and in the future (after the bariatric surgery); the participant must have been fully committed to be successful in this program and is expected to continue with this effort after bariatric surgery; (v) Consensus in the multidisciplinary child obesity team on the diagnosis of non-responding to multidisciplinary lifestyle interventions for now and the near future.
Exclusion criteria
Exclusion criteria: - Unable to consent as appropriate; - Illiteracy (disability to read and understand questionnaires); - Secondary obesity, obesity caused by a medical condition; - Known syndrome (e.g. Prader-Willi syndrome); - Skeletal immaturity (Tanner stage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite outcome: - Proportion of adolescents presented to the national board achieving 20% total weight loss (%TWL) 1 year after surgery; - Incidence of adverse health events and additional surgical intervention during 5 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are: (i) Number of appointments per discipline and follow-up attendance during 5 years follow-up; (ii) Patient satisfaction at 1, 3 and 5 years after surgery and satisfaction of the multidisciplinary team members after 1, 3 and 5 years from start of the study; (iii) Perceived organization of care by the multidisciplinary team members after 1, 3 and 5 years from start of the study. (iv) Change in body weight, change in body mass index (BMI), %TWL and change in BMI standard deviation score during 5 years follow-up; (v) Prevalence and remission of obesity-related comorbidities during 5 years follow-up; (vi) Prevalence of cardio metabolic health parameters during 5 years follow-up; (vii) Bone health measures and incidence of bone fractures during 5 years follow-up; (viii) Quality of life, psychosocial health measures, and educational attainment at 1, 3 and 5 years after surgery; (ix) Body composition at 2 and 5 years after surgery. The secondary endpoints iv, v, vi and viii stated above will be used for this historical cohort as well. | — |
Countries
Netherlands
Outcome results
None listed