Assistance Publique-Hôpitaux de Paris (AP-HP), Nutrition Department, European Hospital Georges Pompidou, Paris, France.
University of Paris, Paris, France.
Obes Rev. 2022 May;23(5):e13420. doi: 10.1111/obr.13420. Epub 2022 Jan 17.
While research publications on bariatric surgery (BS) have grown significantly over the past decade, there is no mapping of the existing body of evidence on this field of research. We performed a systematic review followed by a mapping of randomized controlled trials (RCTs) in BS for people with obesity. From January 2020 to December 2020, we performed a systematic review of RCTs evaluating BS, versus another surgical procedure, or versus a medical control group, through a search of Embase and PubMed. There was no restriction on outcomes for study selection. A total of 114 RCTs were included, most (73.7%) of which were based on a comparison with Roux-en-Y gastric bypass (RYGB) and conducted between 2010 and 2020. Only 15% of the trials were multicenter and few (3.5%) were international. The median number of patients enrolled was 61 (interquartile range [IQR]: 47.3-100). Follow-up time was 1 to 2 years in 36% and 22.8% of the trials, respectively. Weight loss was the most studied criterion (87% of RCTs), followed by obesity-related diseases, and medical and surgical complications (73%, 54%, and 47% of RCTs, respectively). Nutritional deficiency frequency, body composition, and mental health were little studied (20%, 18% and 5% of RCTs, respectively). Our literature review revealed that much research in BS is wasted because of replication of RCTs on subjects for which there is already body of evidence, with small populations and follow-up times mostly below 2 years. Yet several research questions remain unaddressed, and there are few long-term trials. Future studies should take into account the experience of the past 70 years of research in this field.
尽管过去十年间有关减重手术（BS）的研究文献显著增加，但对于该领域的现有证据尚未进行系统性的梳理。我们进行了一项系统评价，并对肥胖人群接受 BS 的随机对照试验（RCT）进行了映射。从 2020 年 1 月至 2020 年 12 月，我们通过 Embase 和 PubMed 对评估 BS 的 RCT 进行了系统评价，比较了 BS 与另一种手术方法或与药物对照组的效果。在研究选择方面，我们没有对结果进行限制。共纳入 114 项 RCT，其中大多数（73.7%）是基于与 Roux-en-Y 胃旁路术（RYGB）的比较，且均在 2010 年至 2020 年间进行。只有 15%的试验为多中心试验，很少（3.5%）为国际试验。纳入患者的中位数为 61 例（四分位距[IQR]：47.3-100）。分别有 36%和 22.8%的试验随访时间为 1 至 2 年。体重减轻是最常研究的标准（87%的 RCT），其次是肥胖相关疾病、医疗和手术并发症（分别占 73%、54%和 47%的 RCT）。营养缺乏频率、身体成分和心理健康的研究较少（分别占 20%、18%和 5%的 RCT）。我们的文献综述显示，由于对已有大量证据的研究对象重复进行 RCT，导致 BS 的大量研究成果浪费，且这些 RCT 的研究人群规模较小，随访时间大多不足 2 年。然而，仍有几个研究问题尚未得到解决，且长期试验较少。未来的研究应考虑到该领域过去 70 年研究的经验。
