D1 | Abstract 15

Annual NUTRIM Symposium 18 November 2020

APPLIED SCIENCE

Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST

Kelly G.H. van de Pas1, 2, Daniëlle S. Bonouvrie1, Wouter K.G. Leclercq1, Anita C.E. Vreugdenhil2, François M. H. van Dielen
1Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.
2 Department of Pediatrics, Maastricht University Medical Center, Maastricht, The Netherlands.
Background:
 The prevalence of overweight and obesity in children is increasing worldwide. Recent data indicate that bariatric surgery is a safe and effective intervention in adolescents with severe obesity following unsuccessful non-surgical treatment. 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. The primary goal of this study is to determine whether SG is non-inferior to RYGB in terms of total body weight loss (TBWL) 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 and randomized to either RYGB or SG. The primary outcome is to determine whether SG is non-inferior to RYGB regarding to the proportion of participants achieving 20% TBWL 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. A historical cohort of adolescents who participated in the lifestyle intervention program COACH of Maastricht University Medical Center will be compared to both study arms. Follow-up will extend into the long term.

Discussion:
 This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity.
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