Department of Pediatrics, Paracelsus Medical University, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität Nürnberg, Nuremberg, Germany.
Department of Pediatrics, Paracelsus Medical University, Salzburg, Austria.
Cochrane Database Syst Rev. 2022 Sep 8;9(9):CD011740. doi: 10.1002/14651858.CD011740.pub2.
BACKGROUND: Child and adolescent overweight and obesity have increased globally and are associated with significant short- and long-term health consequences. OBJECTIVES: To assess the effects of surgery for treating obesity in childhood and adolescence. SEARCH METHODS: For this update, we searched Cochrane Central Register of Controlled Trials, MEDLINE, Latin American and Caribbean Health Science Information database (LILACS), World Health Organization International Clinical Trials Registry Platform (ICTRP)and ClinicalTrials.gov on 20 August 2021 (date of the last search for all databases). We did not apply language restrictions. We checked references of identified studies and systematic reviews. SELECTION CRITERIA: We selected randomised controlled trials (RCTs) of surgical interventions for treating obesity in children and adolescents (age < 18 years) with a minimum of six months of follow-up. We excluded interventions that specifically dealt with the treatment of eating disorders or type 2 diabetes, or which included participants with a secondary or syndromic cause of obesity, or who were pregnant. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently extracted data and assessed the risk of bias using the Cochrane Risk of Bias 2.0 tool. Where necessary, we contacted authors for additional information. MAIN RESULTS: With this update, we did not find any new RCTs. Therefore, this updated review still includes a single RCT (a total of 50 participants, 25 in both the intervention and comparator groups). The intervention focused on laparoscopic adjustable gastric banding surgery, which was compared to a control group receiving a multi-component lifestyle programme. The participating population consisted of Australian adolescents (a higher proportion of girls than boys) aged 14 to 18 years, with a mean age of 16.5 and 16.6 years in the gastric banding and lifestyle groups, respectively. The trial was conducted in a private hospital, receiving funding from the gastric banding manufacturer. For most of the outcomes, we identified a high risk of bias, mainly due to bias due to missing outcome data. Laparoscopic gastric banding surgery may reduce BMI by a mean difference (MD) of -11.40 kg/m (95% CI -13.22 to -9.58) and weight by -31.60 kg (95% CI -36.66 to -26.54) compared to a multi-component lifestyle programme at two years follow-up. The evidence is very uncertain due to serious imprecision and a high risk of bias. Adverse events were reported in 12/25 (48%) participants in the intervention group compared to 11/25 (44%) in the control group. A total of 28% of the adolescents undergoing gastric banding required revisional surgery. The evidence is very uncertain due to serious imprecision and a high risk of bias. At two years of follow-up, laparoscopic gastric banding surgery may increase health-related quality of life in the physical functioning scores by an MD of 16.30 (95% CI 4.90 to 27.70) and change in health scores by an MD of 0.82 (95% CI 0.18 to 1.46) compared to the lifestyle group. The evidence is very uncertain due to serious imprecision and a high risk of bias. No data were reported for all-cause mortality, behaviour change, participants' views of the intervention and socioeconomic effects. Finally, we have identified three ongoing RCTs that are evaluating the efficacy and safety of metabolic and bariatric surgery in children and adolescents. AUTHORS' CONCLUSIONS: Laparoscopic gastric banding led to greater body weight loss compared to a multi-component lifestyle program in one small study with 50 participants. These results have very limited application, primarily due to more recent recommendations derived from observation studies to avoid the use of banding in youth due to long-term reoperation rates. This systematic review update still highlights the lack of RCTs in this field. The authors are concerned that there may be ethical barriers to RTCs in this field, despite the lack of other effective therapies for severe obesity in children and adolescents and the significant morbidity and premature mortality caused by childhood obesity. Nevertheless, future studies, whether pre-registered and planned non-randomised or pragmatic randomised trials, should assess the impact of the surgical procedure and post-operative care to minimise adverse events, including the need for post-operative adjustments and revisional surgery. Long-term follow-up is also critical to comprehensively assess the impact of surgery as participants enter adulthood.
背景:儿童和青少年超重和肥胖的现象在全球范围内有所增加,并且与短期和长期健康后果密切相关。
目的:评估手术治疗儿童和青少年肥胖的效果。
检索方法:本更新版研究于 2021 年 8 月 20 日检索了 Cochrane 对照试验中央注册库、MEDLINE、拉丁美洲和加勒比健康科学信息数据库(LILACS)、世界卫生组织国际临床试验注册平台(ICTRP)和 ClinicalTrials.gov(所有数据库的最后检索日期)。我们没有设置语言限制。我们检查了已确定研究和系统评价的参考文献。
选择标准:我们选择了治疗儿童和青少年(年龄<18 岁)肥胖的手术干预的随机对照试验(RCT),随访时间至少为 6 个月。我们排除了专门针对治疗饮食失调或 2 型糖尿病的干预措施,或包含继发性或综合征性肥胖原因的参与者,或孕妇。
数据收集和分析:我们使用了 Cochrane 预期的标准方法学程序。两位综述作者独立提取数据,并使用 Cochrane 偏倚风险 2.0 工具评估偏倚风险。在必要时,我们联系了作者以获取额外信息。
主要结果:本次更新中,我们没有发现任何新的 RCT。因此,本次更新的综述仍包括一项 RCT(总共 50 名参与者,干预组和对照组各 25 名)。干预措施侧重于腹腔镜可调胃带手术,与接受多组分生活方式计划的对照组进行比较。参与人群为澳大利亚青少年(女孩比例高于男孩),年龄在 14 至 18 岁之间,胃带组和生活方式组的平均年龄分别为 16.5 岁和 16.6 岁。该试验在一家私立医院进行,由胃带制造商提供资金。对于大多数结果,我们发现存在高偏倚风险,主要是由于缺失结局数据导致的偏倚。与多组分生活方式计划相比,腹腔镜胃带手术在两年随访时可能使 BMI 降低 MD-11.40kg/m²(95%CI-13.22 至-9.58)和体重降低 MD-31.60kg(95%CI-36.66 至-26.54)。由于严重的不精确性和高偏倚风险,证据非常不确定。干预组 12/25(48%)的参与者报告了不良事件,而对照组为 11/25(44%)。28%接受胃带手术的青少年需要进行修订手术。由于严重的不精确性和高偏倚风险,证据非常不确定。在两年随访时,腹腔镜胃带手术可能会使身体功能评分的健康相关生活质量增加 MD16.30(95%CI4.90 至 27.70),健康评分变化增加 MD0.82(95%CI0.18 至 1.46)与生活方式组相比。由于严重的不精确性和高偏倚风险,证据非常不确定。没有报告所有原因死亡率、行为改变、参与者对干预的看法和社会经济影响的数据。最后,我们已经确定了三项正在进行的 RCT,这些 RCT 评估了代谢和减重手术在儿童和青少年中的疗效和安全性。
作者结论:在一项纳入 50 名参与者的小型研究中,腹腔镜胃带手术导致的体重减轻明显多于多组分生活方式计划。这些结果的应用范围非常有限,主要是由于最近的观察研究建议避免在青少年中使用带,因为长期再手术率较高。本次系统综述更新仍然突出了该领域 RCT 的缺乏。作者担心,尽管对于儿童和青少年严重肥胖症缺乏其他有效治疗方法,并且儿童肥胖症会导致显著的发病率和过早死亡,但该领域可能存在伦理障碍进行 RCT。然而,未来的研究,无论是预先注册的、计划非随机的还是实用随机的试验,都应该评估手术程序和术后护理的影响,以尽量减少不良事件,包括术后调整和修订手术的需要。长期随访对于全面评估手术的影响也至关重要,因为参与者将进入成年期。
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