Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Oslo, Norway.
Center for Morbid Obesity, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.
JAMA Netw Open. 2024 Jun 3;7(6):e2414340. doi: 10.1001/jamanetworkopen.2024.14340.
Results from long-term follow-up after biliopancreatic diversion with duodenal switch (DS) are scarce.
To compare weight loss, health outcomes, and quality of life 10 years or more after Roux-en-Y-gastric bypass (RYGB) and DS surgery in patients with severe obesity-that is, a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 50 to 60.
DESIGN, SETTING, AND PARTICIPANTS: This open-label randomized clinical trial was conducted at 2 academic bariatric centers in Sweden and Norway. Sixty patients with a BMI of 50 to 60 were included from March 1, 2006, to August 31, 2007. Data were analyzed from August 12, 2022, to January 25, 2023.
Laparoscopic RYGB or laparoscopic DS.
The main outcome was change in BMI after 10 or more years. Secondary outcomes included anthropometric measures, lipid and glycemic profiles, bone mass density, adverse events, gastrointestinal tract symptoms, and health-related quality of life.
Forty-eight of the original 60 patients (80%) were assessed after a median of 12 (range, 9-13) years (mean [SD] age, 48.0 [6.0] years; 35 women [73%]). At follow-up, the mean BMI reductions were 11.0 (95% CI, 8.3-13.7) for RYGB and 20.3 (95% CI, 17.6-23.0) for DS, with a mean between-group difference of 9.3 (95% CI, 5.4-13.1; P < .001). Total weight loss was 20.0% (95% CI, 15.3%-24.7%) for RYGB and 33.9% (95% CI, 27.8%-40.0%) for DS (P = .001). Mean serum lipid levels, except high-density lipoprotein cholesterol and hemoglobin A1c, improved more in the DS group during follow-up. Bone mass was reduced for both groups from 5 to 10 years, with lower bone mass after DS at 10 years. Quality-of-life scores (Obesity-Related Problem Scale and the 36-Item Short Form Health Survey) were comparable across groups at 10 years. The total number of adverse events was higher after DS (135 vs 97 for RYGB; P = .02). More patients in the DS group developed vitamin deficiencies (21 vs 11 for RYGB; P = .008) including 25-hydroxyvitamin D deficiency (19 for DS vs 9 for RYGB; P = .005). Four of 29 patients in the DS group (14%) developed severe protein-caloric malnutrition, of whom 3 (10%) underwent revisional surgery.
In this randomized clinical trial, BMI reduction was greater after DS, but RYGB had a better risk profile over 10 years. Biliopancreatic diversion with DS may not be a better surgical strategy than RYGB for patients with a BMI of 50 to 60.
ClinicalTrials.gov Identifier: NCT00327912.
重要性：胆胰转流十二指肠转位术（DS）后长期随访的结果很少见。
目的：比较严重肥胖患者（BMI 为 50 至 60）接受 Roux-en-Y 胃旁路术（RYGB）和 DS 手术后 10 年或更长时间的减重效果、健康结果和生活质量。
设计、地点和参与者：这是一项在瑞典和挪威的 2 个学术减重中心进行的开放性标签随机临床试验。2006 年 3 月 1 日至 2007 年 8 月 31 日，纳入了 60 名 BMI 为 50 至 60 的患者。数据分析于 2022 年 8 月 12 日至 2023 年 1 月 25 日进行。
干预措施：腹腔镜 RYGB 或腹腔镜 DS。
主要结局和测量：主要结局是 10 年或更长时间后 BMI 的变化。次要结局包括人体测量指标、血脂和血糖谱、骨密度、不良事件、胃肠道症状和健康相关生活质量。
结果：原始 60 名患者中的 48 名（80%）在中位数为 12 年（范围为 9-13 年）后进行了评估（平均[标准差]年龄为 48.0[6.0]岁；35 名女性[73%]）。随访时，RYGB 的平均 BMI 降低为 11.0（95%置信区间，8.3-13.7），DS 为 20.3（95%置信区间，17.6-23.0），组间平均差异为 9.3（95%置信区间，5.4-13.1；P < .001）。RYGB 的总减重为 20.0%（95%置信区间，15.3%-24.7%），DS 为 33.9%（95%置信区间，27.8%-40.0%）（P = .001）。在随访过程中，除了高密度脂蛋白胆固醇和糖化血红蛋白外，RYGB 组的平均血清血脂水平有所改善。两组的骨密度从 5 年开始下降，DS 组在 10 年后的骨密度更低。两组的生活质量评分（肥胖相关问题量表和 36 项简明健康调查）在 10 年后相似。DS 组的不良事件总数较高（135 比 RYGB 的 97；P = .02）。DS 组更多患者发生维生素缺乏症（21 比 RYGB 的 11；P = .008），包括 25-羟维生素 D 缺乏症（19 比 RYGB 的 9；P = .005）。DS 组 29 名患者中的 4 名（14%）出现严重的蛋白质-热量营养不良，其中 3 名（10%）接受了修正手术。
结论和相关性：在这项随机临床试验中，DS 后 BMI 降低幅度更大，但 RYGB 在 10 年内的风险状况更好。对于 BMI 为 50 至 60 的患者，胆胰转流十二指肠转位术可能不是比 RYGB 更好的手术策略。
试验注册：ClinicalTrials.gov 标识符：NCT00327912。
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