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Purpose: Bariatric surgery is regarded as a valuable treatment option for adolescents with severe obesity. However, high-quality evidence of its superiority over prolonged conservative treatment with multidisciplinary lifestyle intervention (MLI) is limited. This study investigated the efficacy and safety of bariatric surgery in adolescents without sufficient weight loss after MLI for severe obesity., Methods: A two-group randomized controlled trial was designed to assess one-year health effects of bariatric surgery in adolescents with severe obesity. The participants were referred by pediatricians after completing MLI without sufficient effects. Eligible for participation were adolescents aged 14-16 years with severe obesity (age- and sex-adjusted body mass index (BMI) using the International Obesity Task Force cutoffs: BMI ≥40 kg/m 2 , or ≥35 kg/m 2 in combination with comorbidity). Participants were assigned to MLI combined with laparoscopic adjustable gastric banding (n = 29) versus only MLI (n = 30). Participants were included from 2011 to 2019. Main outcomes were weight change and sex- and age-specific BMI loss. Additionaly, glucose metabolism, blood pressure and lipid profile were analysed., Results: 53 patients completed the 12-months follow-up (89.8%). Mean (±standard deviation [SD]) weight loss in the surgery group was 11.2 ± 7.8% after 12 months, compared to a weight gain of 1.7 ± 8.1% in the control group. The fasting insulin, insulin resistance score and lipid profile improved significantly in the surgery group., Discussion: Bariatric surgery was associated with substantial weight loss and improvements in glucose and lipid metabolism after 12 months compared to conservative treatment in adolescents with severe obesity., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: In the Netherlands, bariatric surgery in adolescents is currently only allowed in the context of scientific research. Besides this, there was no clinical pathway for bariatric surgery in adolescents. In this paper, the development of a comprehensive clinical pathway for bariatric surgery in adolescents with severe obesity in the Netherlands is described., Methods: The clinical pathway for bariatric surgery in adolescents consists of an eligibility assessment as well as comprehensive peri- and postoperative care. Regarding the eligibility assessment, the adolescents need to be identified by their attending pediatricians and afterwards be evaluated by specialized pediatric obesity units. If the provided treatment is considered to be insufficiently effective, the adolescent will anonymously be evaluated by a national board. This is an additional diligence procedure specifically established for bariatric surgery in adolescents. The national board consists of independent experts regarding adolescent bariatric surgery and evaluates whether the adolescents meet the criteria defined by the national professional associations. The final step is an assessment by a multidisciplinary team for adolescent bariatric surgery. The various disciplines (pediatrician, bariatric surgeon, psychologist, dietician) evaluate whether an adolescent is eligible for bariatric surgery. In this decision-making process, it is crucial to assess whether the adolescent is expected to adhere to postoperative behavioral changes and follow-up. When an adolescent is deemed eligible for bariatric surgery, he or she will receive preoperative counseling by a bariatric surgeon to decide on the type of bariatric procedure (Roux-en-Y gastric bypass or sleeve gastrectomy). Postoperative care consists of intensive guidance by the multidisciplinary team for adolescent bariatric surgery. In this guidance, several regular appointments are included and additional care will be provided based on the needs of the adolescent and his or her family. Furthermore, the multidisciplinary lifestyle intervention, in which the adolescents participated before bariatric surgery, continues in coordination with the multidisciplinary team for adolescent bariatric surgery, and this ensures long-term counseling and follow-up., Conclusion: The implementation of bariatric surgery as an integral part of a comprehensive treatment for adolescents with severe obesity requires the development of a clinical pathway with a variety of disciplines., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: Recent data support the use of bariatric surgery in adolescents with severe obesity following unsuccessful non-surgical treatments. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) have demonstrated reasonably similar weight loss and reduction of obesity related comorbidities in randomized trials in adults. SG has internationally become the most commonly used procedure in adolescents, yet long-term outcome data are lacking. No randomized controlled trial comparing SG and RYGB has been performed in adolescents., Objective: Determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss in adolescents with severe obesity., Methods: A multicenter randomized controlled non-inferiority trial. Two hundred sixty-four adolescents aged 13-17 (Tanner stage ≥IV) with severe obesity (corrected for age and sex) will be included. Adolescents agreeing to participate will be randomized to either RYGB or SG. The primary outcome is the proportion of participants achieving 20% TBW loss at 3 years postoperatively. Secondary outcomes include (i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition. Follow-up will extend into the long term., Results: Not applicable., Discussion: This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity., Trial Registration: The trial is registered at the Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020).

Background: Obesity in children and adolescents is an increasing problem associated with multiple co-morbidities including metabolic and endocrine changes, cardiovascular abnormalities, and impaired quality of life. Combined lifestyle interventions are the current standard treatment for severe obesity in children. However, the medium- and long-term results of these interventions are relatively poor. Bariatric surgery shows substantial weight loss and health improvement in adults and retrospective studies in adolescents show similar outcomes. However, well-designed prospective studies in this young age group are rare. Our objectives are to determine whether combining surgery with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction compared to lifestyle interventions solely, and to assess its effect on obesity-associated co-morbidities in a prospective randomized controlled setting., Methods: Patients aged 14-16 years with sex- and age-adjusted BMI > 40 kg/m 2 (or > 35 kg/m 2 with comorbidity) and failure to achieve weight reduction > 5% during at least one year of combined lifestyle interventions are included in this trial. Randomization determines whether laparoscopic adjustable gastric banding will be added to combined lifestyle intervention throughout the trial period. Sixty children will be included in this trial. Follow-up visits are planned at 6 months, 1,2 and 3 years. Primary endpoints are percentage of total weight loss, and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour., Discussion: This randomized controlled trial is designed to provide important information about the safety and efficacy of laparoscopic adjustable gastric banding treatment in severely obese adolescents with unsuccessful combined lifestyle interventions. The reversibility of this surgical procedure forms a strong argument to decide for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy., Trial Registration: The BASIC trial is registered in the register of ClinicalTrials.gov since July 2010, Identifier: NCT01172899.