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Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up. 法国单吻合术十二指肠回肠旁路与套筒胃切除术相比（SADISLEEVE）的有效性和安全性：一项随机、开放标签、2年随访的优势试验的结果。

IF 88.5 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

The Lancet

Pub Date : 2025-08-23 DOI: 10.1016/S0140-6736(25)01070-0

Maud Robert, Tigran Poghosyan, Nicolas Romain-Scelle, Sebastien Czernichow, Dominique Delaunay, Adrien Sterkers, Litavan Khamphommala, Andrea Lazzati, Claire Blanchard, Robert Caiazzo, François Pattou, Emmanuel Disse

Background: Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.

Methods: This multicentre, open-label, individually randomised superiority trial was conducted in France; patients were recruited from 22 bariatric institutions, mostly public academic hospitals. Key inclusion criteria were patients with a BMI ≥40 kg/m² or ≥35 kg/m² with obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, or osteoarthrosis), and a candidate for SADI-S or RYGB gastric bypass as a primary surgery or after a sleeve gastrectomy. Main key exclusions included previous bariatric surgery (other than sleeve gastrectomy), inflammatory bowel disease, type 1 diabetes, and untreated Helicobacter pylori infection. Participants were randomly assigned (1:1) to SADI-S or RYGB, stratified by centre, failure of sleeve gastrectomy, and presence of type 2 diabetes. The primary endpoint was percentage excess weight loss (%EWL) at 2 years (%EWL=[(weight at 2 years - initial weight)/(initial weight - ideal weight)] × 100). The study is registered with ClinicalTrials.gov, NCT03610256 and is completed.

Findings: Between Nov 8, 2018, and Sept 29, 2021, a total of 381 patients were randomly assigned (intention-to-treat population) and included in the primary analysis (SADI-S: 190, RYGB: 191). Mean age was 44·4 years (SD 10·64), mean BMI was 46·2 kg/m² (6·40), 265 (70%) were female, and 79 (21%) had a primary sleeve gastrectomy. 43 (12%) of 370 participants were lost to follow-up. At 2 years, the mean %EWL was statistically significantly higher in the SADI-S group compared with the RYGB group (-76·0% [SD 26·7] vs -68·1% [28·7], confirming the superiority of SADI-S (mean difference -6·72% [95% CI -12·64 to -0·80], p=0·026). The primary outcome was missing for 78 (20%) of 381 participants, with 46 (59%) of 78 participants in the SADI-S group and 32 (41%) of 78 in the RYGB group, p=0·09. The number of serious adverse events related to the surgical technique in the safety population, including all operated patients, was 40 in the SADI-S group including three anastomotic leaks and eight severe diarrhoea compared with 35 in the RYGB group including five internal hernia and five severe abdominal pain cases of which two required diagnostic laparoscopy.

Interpretation: SADI-S showed superior weight loss compared with RYGB at 2 years, with a similar safety profile.

Funding: French Ministry of Health (Direction Générale de l'offre de Soin - DGOS).

背景：自2007年以来，单一吻合十二指肠回肠旁路与套筒胃切除术（SADI-S）被提出作为Roux-en-Y胃旁路（RYGB）治疗肥胖的替代方案。我们进行了一项多中心随机试验，假设SADI-S在2年随访时可能比RYGB更有效。方法：这项多中心、开放标签、单独随机的优势试验在法国进行；患者从22家减肥机构招募，其中大多数是公立学术医院。主要纳入标准是BMI≥40 kg/m2或≥35 kg/m2伴有肥胖相关合并症（2型糖尿病、高血压、血脂异常、睡眠呼吸暂停或骨关节病）的患者，以及作为主要手术或袖式胃切除术后SADI-S或RYGB胃旁路手术的候选患者。主要排除因素包括既往减肥手术（袖胃切除术除外）、炎症性肠病、1型糖尿病和未经治疗的幽门螺杆菌感染。参与者被随机分配（1:1）到SADI-S或RYGB组，按中心、套筒胃切除术失败和2型糖尿病的存在进行分层。主要终点是2年体重减重百分比（%EWL）（%EWL=[（2年体重-初始体重）/（初始体重-理想体重）]× 100）。该研究已在ClinicalTrials.gov注册，编号NCT03610256，并已完成。结果：在2018年11月8日至2021年9月29日期间，共有381名患者被随机分配（意向治疗人群）并纳入主要分析（SADI-S: 190, RYGB: 191）。平均年龄44.4岁（SD 10.64），平均BMI为46.2 kg/m2(6.40)，女性265例（70%），79例（21%）为原发性袖式胃切除术。370名参与者中有43人（12%）失去随访。2年时，SADI-S组的平均EWL %明显高于RYGB组（- 76.0% [SD 26.7] vs - 68.1%[28.7]），证实了SADI-S的优越性（平均差异为- 6.72% [95% CI - 12.64 ~ - 0.80], p= 0.026）。381名受试者中有78名（20%）缺少主要结局，其中SADI-S组78名受试者中有46名（59%）缺少主要结局，RYGB组78名受试者中有32名（41%）缺少主要结局，p= 0.09。包括所有手术患者在内的安全人群中，SADI-S组与手术技术相关的严重不良事件数量为40例，包括3例吻合口渗漏和8例严重腹泻，而RYGB组为35例，包括5例内疝和5例严重腹痛，其中2例需要诊断性腹腔镜检查。解释：与RYGB相比，SADI-S在2年后表现出更好的减肥效果，并且具有相似的安全性。资助：法国卫生部（ssoin - DGOS - ssoin - DGOS方向）。

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