Researchers from Europe have initiated the first randomised controlled trial that will compare sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) in adolescents with severe obesity. The TEEN-BEST trial is designed to determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss.
The trial will enrol 264 adolescents (aged 13–17) with severe obesity (corrected for age and sex) who will randomised to either RYGB or SG. The primary outcome is the proportion of participants achieving 20% TBW loss at three years post-operatively. An outline of the clinical trial was published in the paper, ‘Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial’, featured on BMC Surgery.
The main objective of this trial is to obtain level one evidence regarding differences in clinical outcomes between RYGB and SG (both performed as add on to lifestyle intervention) and by assessing efficacy and safety, the researchers aim to provide guidance regarding procedure choice based on reliable risk/benefit data overall as well as in subgroups.
Secondary outcomes will include:
- change in body weight, BMI and BMI standard deviation score
- incidence of adverse health events and need for additional surgical intervention
- resolution of obesity-related comorbidities
- prevalence of cardio metabolic risk factor measures
- bone health measures and incidence of bone fractures
- quality of life including psychosocial health, patient satisfaction and educational attainment and;
- body composition.
The trial has two phases. Phase 1 is an internal pilot of twenty patients at each of the two initiating surgical sites (10 + 10 SG and 10 + 10 RYGB in total) to establish feasibility. Phase 2 will be the full multicentre RCT and patient recruitment started in May 2020 until May 2023. Follow-up within the RCT will be planned for a minimum of five years. A matched group, identified from historical data in the multimodal lifestyle intervention program (COACH) of Maastricht University Medical Center, will be used as a non-surgical comparator to the bariatric procedures.
TEEN-BEST trial will initially be conducted at two surgical sites (a non-academic Dutch centre and an academic Swedish centre), with the potential to recruit additional sites after successful initiation. All surgical centres will collaborate with a child obesity centre, which will initially be three sites (one academic and one non-academic Dutch centre and one academic Swedish centre).
“In short, among adolescents with severe obesity who do not respond sufficiently to multimodal lifestyle interventions, bariatric surgery is a viable option. Although both SG and RYGB showed successful weight loss and reduction of obesity related comorbidities in adolescents thus far, long-term outcome data of SG in adolescents has been limited…’ the authors stated. “Therefore, we propose an RCT comparing SG with RYGB in adolescents with severe obesity. TEEN-BEST will be the first randomised controlled trial comparing SG and RYGB integrated in the stepped/matched care of adolescents with severe obesity, thus combining the benefits of both multimodal lifestyle intervention and surgical intervention, and will guide future adolescent bariatric practice.”
The multi-centre RCT will be carried out by researchers from Máxima Medical Center, Eindhoven/Veldhoven, Jeroen Bosch Hospital, ‘s-Hertogenbosch, Rijnstate Hospital, Arnhem, Maastricht University Medical Center, Maastricht, The Netherlands, Gothenburg University, Gothenburg, Linköping University, Linköping, Vrinnevi hospital, Norrköping, Sweden and the Royal College of Surgeons of England, London, UK.
To access the paper outlining the design of TEEN-BEST, please click here