Bonouvrie Daniëlle S, Beamish Andrew J, Leclercq Wouter K G, van Mil Edgar G A H, Luijten Arijan A P M, Hazebroek Eric J, Vreugdenhil Anita C E, Olbers Torsten, van Dielen François M H
Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.
Department of Gastrosurgical Research and Education - Institute of Clinical Sciences, Gothenburg University, Gothenburg, Sweden.
BMC Surg. 2020 Jun 3;20(1):117. doi: 10.1186/s12893-020-00778-9.
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.
Determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss in adolescents with severe obesity.
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.
Not applicable.
This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity.
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).
近期数据支持在非手术治疗失败的重度肥胖青少年中采用减肥手术。在成人随机试验中，袖状胃切除术（SG）和 Roux-en-Y 胃旁路术（RYGB）已显示出相当相似的体重减轻和肥胖相关合并症的减少。SG 在国际上已成为青少年中最常用的手术，但缺乏长期结果数据。尚未在青少年中进行比较 SG 和 RYGB 的随机对照试验。
确定在重度肥胖青少年中，就总体重（TBW）减轻而言，SG 是否不劣于 RYGB。
一项多中心随机对照非劣效性试验。将纳入 264 名年龄在 13 - 17 岁（坦纳分期≥IV 期）的重度肥胖青少年（根据年龄和性别校正）。同意参与的青少年将被随机分配至 RYGB 或 SG 组。主要结局是术后 3 年实现 TBW 减轻 20%的参与者比例。次要结局包括：（i）体重、体重指数（BMI）和 BMI 标准差评分的变化；（ii）不良健康事件的发生率和额外手术干预的需求；（iii）肥胖相关合并症的缓解情况；（iv）心血管代谢危险因素指标的患病率；（v）骨骼健康指标和骨折发生率；（vi）生活质量，包括心理社会健康、患者满意度和教育程度；（vii）身体成分。随访将持续至长期。
不适用。
据我们所知，本研究将是第一项比较 SG 和 RYGB 在重度肥胖青少年中的随机对照试验。
该试验于 2018 年 7 月 26 日在荷兰试验注册中心注册 - NTR7191 - https://www.trialregister.nl/trial/7191（方案版本 5.0 - 2020 年 2 月 3 日）。
