Metabolic/bariatric surgery

代谢 / 减肥手术
  • 文章类型: Journal Article
    背景:这项研究调查了代谢/减肥手术(MBS)如何影响肥胖正常甲状腺个体的甲状腺激素(TH)水平和TH抵抗,关注它们与身体成分变化的相关性。
    方法:我们纳入了470名肥胖个体和118名对照进行基线评估,和125名接受MBS的肥胖患者进行纵向研究。收集有关身体成分和甲状腺功能的数据。评估基线与甲状腺功能和身体成分变化之间的相关性。
    结果:在肥胖组中,促甲状腺激素(TSH),游离三碘甲状腺原氨酸(fT3)水平,甲状腺反馈分位数指数(TFQI)在MBS后升高并显着降低,内脏脂肪面积(VFA)和体脂百分比,而骨骼肌质量(SMM)百分比增加。术前校正年龄和性别的偏相关分析显示TSH与VFA呈正相关(r=0.109,P=0.019)。体脂百分比(r=0.114,P=0.013),与SMM百分比呈负相关(r=-0.104,P=0.024)。在中心TH抵抗指数和身体成分之间观察到类似的相关性,但在对照组中没有发现显著的相关性。MBS后,TSH降低与VFA降低呈正相关(r=0.251,P=0.006),SMM百分比升高(r=0.233,P=0.011)。虽然VFA和体脂百分比的减少与中央甲状腺激素抵抗的改善有关,外周TH转化率下降。
    结论:MBS显著影响甲状腺功能和TH抵抗,与身体成分的变化有显著的相关性。
    BACKGROUND: This study investigates how metabolic/bariatric surgery (MBS) affects thyroid hormone (TH) levels and TH resistance in obese euthyroid individuals, focusing on their correlation with changes in body composition.
    METHODS: We included 470 obese individuals and 118 controls for baseline assessment, and 125 obese patients receiving MBS for longitudinal study. Data on body composition and thyroid function were collected. Correlations between baseline and changes in thyroid function and body composition were assessed.
    RESULTS: In the obese group, thyroid stimulating hormone (TSH), free triiodothyronine (fT3) levels, and thyroid feedback quantile-based index (TFQI) were elevated and significantly decreased post-MBS, along with visceral fat area (VFA) and body fat percentages, while skeletal muscle mass (SMM) percentage increased. Preoperative partial correlation analysis adjusted for age and sex revealed that TSH positively correlated with VFA (r=0.109, P=0.019), body fat percentage (r=0.114, P=0.013), and negatively correlated with SMM percentage (r=-0.104, P=0.024). Similar correlations were observed between central TH resistance indices and body composition, but no significant correlations were found in the control group. Post-MBS, decreased TSH positively correlated with decreased VFA (r=0.251, P=0.006) and increased SMM percentage (r=0.233, P=0.011). While reductions in VFA and body fat percentage were linked to improved central thyroid hormone resistance, a decrease in peripheral TH conversion was noted.
    CONCLUSIONS: MBS significantly impacts thyroid function and TH resistance, with notable correlations to changes in body composition.
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  • 文章类型: Journal Article
    背景:一项吻合胃旁路术(OAGB)与Roux-en-Y胃旁路术(RYGB)和袖状胃切除术(SG)在身体成分和肌肉骨骼健康方面的比较研究有限。
    目的:比较身体成分的变化,面骨矿物质密度(aBMD),肌肉力量,和身体机能在OAGB之后的第一年,RYGB和SG在英国的医疗保健环境中。
    方法:这是对BARI-LIFESTYLE试验在119名成年人中进行的二次分析(77%为女性;平均值±SD,年龄:45.9±10.3岁;BMI:43.6±5.5kg/m2)接受OAGB(n=19),RYGB(n=39)和SG(n=61)。通过双能X射线吸收法测量身体成分和aBMD,握力,我们在术前和术后12个月评估了静坐(STS)测试和6分钟步行测试(6MWT).
    结果:OAGB,RYGB,和SG表现出类似的体重减轻,身体脂肪和瘦体重(组内比较,p<0.001)。所有手术类型均与全髋关节aBMD降低相关,股骨颈,和腰椎,与SG相比,OAGB和RYGB后更明显(所有p<0.03),虽然OAGB和RYGB之间没有区别。尽管绝对握力降低,相对握力,STS测试和6MWT术后改善(所有p<0.02),手术没有区别。
    结论:OAGB,RYGB,和SG导致相当的体重减轻,身体成分的变化以及相对肌肉力量和身体功能的改善。OAGB和RYGB,与SG相比,导致临床相关部位的BMD降低幅度更大。未来的长期研究应该探讨这些BMD降低是否会转化为更大的骨折风险。
    BACKGROUND: There are limited comparative studies between one anastomosis gastric bypass (OAGB) versus Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) on body composition and musculoskeletal health.
    OBJECTIVE: To compare changes in body composition, areal bone mineral density (aBMD), muscle strength, and physical function in the first year following OAGB, RYGB and SG within a UK-based healthcare setting.
    METHODS: This is a secondary analysis of the BARI-LIFESTYLE trial in 119 adults (77% women; mean±SD, age: 45.9±10.3 years; BMI: 43.6±5.5 kg/m2) who underwent OAGB (n=19), RYGB (n=39) and SG (n=61). Body composition and aBMD by dual energy x-ray absorptiometry, handgrip strength, sit-to-stand (STS) test and 6-minute walking test (6MWT) were assessed pre-surgery and at 12 months post-surgery.
    RESULTS: OAGB, RYGB, and SG exhibited similar reductions in body weight, body fat and lean mass (within-group comparisons, p<0.001). All surgery types were associated with reductions in aBMD at the total hip, femoral neck, and lumbar spine, which were more pronounced after OAGB and RYGB compared to SG (all p<0.03), though no difference between OAGB and RYGB. Despite reductions in absolute handgrip strength, relative handgrip strength, STS test and 6MWT improved post-surgery (all p<0.02), with no differences by surgical procedure.
    CONCLUSIONS: OAGB, RYGB, and SG resulted in comparable weight loss, changes in body composition and improvements in relative muscle strength and physical function. OAGB and RYGB, compared with SG, led to greater BMD reductions at clinically relevant sites. Future long-term studies should explore whether these BMD reductions translate into a greater fracture risk.
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  • 文章类型: Journal Article
    背景:需要简单的手术方法,以最大程度地减少吻合并发症,同时改善代谢/减肥手术(MBS)结局。
    方法:这项前瞻性单中心研究评估了可行性,安全,以及新型线性磁吻合系统(LMAS[3cm])在进行左右十二指肠回肠造口术(MagDI)二分置以修改临床上次优的原发性袖状胃切除术(SG)中的功效。重度肥胖伴/不伴2型糖尿病(T2D)的患者体重减轻欠佳,重新获得,和/或在SG接受MagDI修订后T2D复发。远端和近端磁铁通过内窥镜输送到回肠和十二指肠,并通过腹腔镜辅助对齐。逐渐的磁体融合形成DI双分区。
    方法:技术可行性,1年时的安全性(Clavien-Dindo[CD]严重不良事件分类)。次要终点:MBS重量和T2D减少。
    结果:2022年7月29日至2023年3月28日,24名患者(95.8%为女性,平均年龄44.9±1.5岁,体重指数[BMI]39.4±1.3kg/m2)接受MagDI。通过正确的磁铁放置达到可行性(平均手术时间63.5±3.3分钟),创造了专利吻合,100.0%的患者肛门和磁铁通道。有4例CD-III轻度或中度严重不良事件,0.0%与LMAS或MagDI相关:0.0%吻合口漏,阻塞,出血,感染,再干预,或死亡。平均BMI降低2.1kg/m2(p<0.05);总体重减轻5.3%,过量体重减轻16.4%;T2D患者改善。
    结论:使用新型3-cmLMAS修改临床次优SG的单吻合术MagDI程序在技术上很简单,没有发生重大并发症,减轻体重恢复,并恢复了有临床意义的体重减轻。
    结果:
    NCT05322122。
    BACKGROUND: Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed.
    METHODS: This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition.
    METHODS: technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction.
    RESULTS: July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m2) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m2 (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved.
    CONCLUSIONS: The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss.
    RESULTS:
    UNASSIGNED: NCT05322122.
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  • 文章类型: Journal Article
    目标:为了提供个人的整体观点,外部,以及影响代谢/减肥手术患者坚持营养和饮食的心理因素。
    方法:这种对混合方法研究的系统综合涉及对英语数据库中文章的全面搜索,包括PubMed,科克伦图书馆,WebofScience,EBSCO,Scopus,和Embase,以及中国数据库。搜索包含从数据库开始到2023年6月发布的文章。在对文献质量进行评估并从所选研究中提取相关信息之后,整合了定量和定性研究的数据。提取的数据分别进行分析,并确定和总结主题,以阐明影响营养和膳食指南依从性的因素.该方法符合JoannaBriggs研究所(JBI)建议的混合方法系统评估指南。
    结果:确定了三个主题及其相应的描述性元素,包括:(1)个人因素:主观因素(态度、能力,意识,行为),客观因素(年龄,性别,工作状态,经济水平,身体活动,饮食习惯,体重变化);(2)外部因素:药物(药丸的数量,摄入时间的复杂性,副作用,难闻的气味或味道),手术因素,社会影响(家庭成员,营养师,和同龄人);(3)心理因素:自我效能感,依恋焦虑,和心理健康问题。
    结论:综合综述了代谢和减重手术患者术后营养和饮食依从性的影响因素。它强调了临床工作人员根据这些不同因素定制干预措施的必要性,以及重视患者的心理健康,给予多维饮食指导和保健。
    OBJECTIVE: To offer a holistic view of the personal, external, and psychological factors influencing adherence to nutrition and diet in patients undergoing metabolic/bariatric surgery.
    METHODS: This systematic synthesis of mixed methods research involved a comprehensive search for articles in English databases, including PubMed, Cochrane Library, Web of Science, EBSCO, Scopus, and Embase, as well as Chinese databases. The search encompassed articles published from the inception of the database up to June 2023. Following the evaluation of literature quality and extraction of relevant information from the selected studies, data from both quantitative and qualitative studies were integrated. The extracted data were analyzed separately, and themes were identified and summarized to elucidate the factors influencing adherence to nutritional and dietary guidelines. The methodology adhered to the guidelines recommended by the Joanna Briggs Institute (JBI) for mixed methods systematic evaluations.
    RESULTS: Three themes and their corresponding descriptive elements were identified, including: (1) Personal factors: subjective factors (attitude, capability, awareness, behaviors), objective factors (age, sex, work status, economic level, physical activity, dietary habits, weight change); (2) External factors: medication (quantity of pills, complexity of intake times, side effects, unpleasant smell or taste), surgery factor, social influences (family members, dietitians, and peers); (3) Psychological factors: self-efficacy, attachment anxiety, and mental health problems.
    CONCLUSIONS: The synthesis provided a comprehensive overview of the factors influencing postoperative compliance of nutrition and diet among patients undergoing metabolic and bariatric surgery. It emphasizes the necessity for clinical staff to tailor interventions based on these diverse factors, as well as to attach importance to patients\' mental health, giving multidimensional dietary guidance and health care.
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  • 文章类型: Journal Article
    背景:寻求解决在形成胃空肠造口术(GJ)吻合术中的技术挑战并维持其开放的手段。
    目的:评估新型线性磁性压缩吻合(MCA)装置在猪中形成专利GJ与缝合空肠肠切开术(JE)部位的临床前可行性和愈合效果。
    方法:单中心兽医检测设施。
    方法:在6周内评估了3种原型尺寸(4、6和8cm)的金属MCA装置(MCAD)形成专利GJ的可行性。远端磁铁通过腹腔镜插入空肠,在胃镜下将近端磁铁放置在胃中;将磁铁对齐以逐渐形成吻合口,自我分离,然后被开除.尸检时,评估MCA的通畅性,并与JE组织进行比较,以评估伤口愈合情况。
    结果:MCADs在GJ位置对齐,无并发症。在5/6MCAD对中,移位发生在7至26天之间;排出13-31天;1对MCAD保留在胃中。尸检时,所有的猪都很健康,获得平均15.0公斤。在接受4-cm或6-cmMCADs的2/4猪中,吻合口不够通畅,因为它们的线性长度太小。但是,接受8厘米MCADs的两只猪的吻合口保持完全通畅。与缝合肠切开术相比,MCA标本中的炎症和纤维化最小。
    结论:一种新颖的线性MCA装置是可行的,并且在猪中有效地创建了具有最小炎症和纤维化的专利GJ吻合术。MCAD可能适用于临床评估。
    BACKGROUND: Means of addressing technical challenges in forming gastrojejunostomy (GJ) anastomoses and maintaining their patency are sought.
    OBJECTIVE: Evaluation of preclinical feasibility and healing efficacy of a novel linear magnetic compression anastomosis (MCA) device to form a patent GJ versus sutured jejunal enterotomy (JE) sites in swine.
    METHODS: Single-center veterinary testing facility.
    METHODS: Feasibility of 3 prototype sizes (4, 6, and 8 cm) of a metal MCA device (MCAD) to form a patent GJ was evaluated over 6 weeks. A distal magnet was laparoscopically inserted in the jejunum, a proximal magnet was placed gastroscopically in the stomach; magnets were aligned to gradually form an anastomosis, self-detached, and be expelled. At necropsy, MCAs were assessed for patency and compared with JE tissues to evaluate wound healing.
    RESULTS: MCADs aligned at the GJ location without complications. In 5/6 MCAD pairs, dislodgement occurred between 7 and 26 days; expulsion 13-31 days; 1 MCAD pair was retained in the stomach. At necropsy, all pigs were healthy, gaining a mean 15.0 kg. Anastomoses were not adequately patent in 2/4 pigs receiving the 4-cm or 6-cm MCADs because their linear length was too small. But, anastomoses of both pigs receiving the 8-cm MCADs maintained full patency. Minimal inflammation and fibrosis were seen in MCA specimens versus sutured enterotomies.
    CONCLUSIONS: A novel linear MCA device was feasible and effectively created a patent GJ anastomosis in swine with minimal inflammation and fibrosis. The MCAD may be appropriate for clinical evaluation.
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  • 文章类型: Journal Article
    背景:单吻合术代谢/减肥手术可以减少吻合并发症的发生率。本研究旨在评估使用磁压缩吻合术(MCA)进行左右十二指肠回肠(DI)两置的可行性和安全性。此外,初步疗效,生活质量(QoL),并评估了通过DI双分区的食物分布。
    方法:身体质量指数(BMI)≥35.0至50.0kg/m2的患者接受了磁铁吻合系统(MS)和袖状胃切除术(SG)的左右DI分配。通过内窥镜定位,在腹腔镜辅助下将远端磁铁(回盲瓣近端250厘米)和近端磁铁(十二指肠的第一部分)对齐,以启动MCA。一项同位素研究评估了通过双分区的过境。
    结果:在2022年3月14日至2022年6月1日之间,有10名患者(BMI为44.2±1.3kg/m2)接受了侧向MSDI。在10名患者中,有9名同时进行SG。中位手术时间为161.0分钟(IQR,108.0-236.0),中位住院时间为3天(IQR,2-40).配对磁体在中位数为43天的时间内排出(IQR,21-87).1年内未发生与器械相关的严重晚期事件。在磁铁排出后和1年时,所有吻合均为专利,直径令人满意。各自的BMI,BMI降低,和总重量损失分别为28.9±1.8kg/m2,15.2±1.8kg/m2和34.2%±4.1%,分别。值得注意的是,70.0%的患者表示非常满意。同位素研究发现,通过回肠环转运的餐食的中位数为19.0%。
    结论:在II级至III级肥胖的成年人中,与SG并排分配MCADI是可行的,安全,1年随访时QoL良好,效率高。此外,19%的摄入食物直接进入回肠。
    BACKGROUND: Single-anastomosis metabolic/bariatric surgery procedures may lessen the incidence of anastomotic complications. This study aimed to evaluate the feasibility and safety of performing side-to-side duodenoileal (DI) bipartition using magnetic compression anastomosis (MCA). In addition, preliminary efficacy, quality of life (QoL), and distribution of food through the DI bipartition were evaluated.
    METHODS: Patients with a body mass index (BMI) of ≥35.0 to 50.0 kg/m2 underwent side-to-side DI bipartition with the magnet anastomosis system (MS) with sleeve gastrectomy (SG). By endoscopic positioning, a distal magnet (250 cm proximal to the ileocecal valve) and a proximal magnet (first part of the duodenum) were aligned with laparoscopic assistance to inaugurate MCA. An isotopic study assessed transit through the bipartition.
    RESULTS: Between March 14, 2022 to June 1, 2022, 10 patients (BMI of 44.2 ± 1.3 kg/m2) underwent side-to-side MS DI. In 9 of 10 patients, an SG was performed concurrently. The median operative time was 161.0 minutes (IQR, 108.0-236.0), and the median hospital stay was 3 days (IQR, 2-40). Paired magnets were expelled at a median of 43 days (IQR, 21-87). There was no device-related serious advanced event within 1 year. All anastomoses were patent with satisfactory diameters after magnet expulsion and at 1 year. Respective BMI, BMI reduction, and total weight loss were 28.9 ± 1.8 kg/m2, 15.2 ± 1.8 kg/m2, and 34.2% ± 4.1%, respectively. Of note, 70.0% of patients reported that they were very satisfied. The isotopic study found a median of 19.0% of the meal transited through the ileal loop.
    CONCLUSIONS: Side-to-side MCA DI bipartition with SG in adults with class II to III obesity was feasible, safe, and efficient with good QoL at 1-year follow-up. Moreover, 19% of ingested food passed directly into the ileum.
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  • 文章类型: Multicenter Study
    背景:传统的代谢/减肥外科吻合术与缝线/钉可能会导致严重的不良事件(AE)。
    目的:研究目的是评估可行性,安全,以及使用新型磁性压缩吻合装置(磁体吻合系统[MS])进行原发性和改良侧对侧十二指肠回肠造口术(DI)的有效性。
    方法:多中心:私人诊所和大学医院。
    方法:在体重指数([BMI,kg/m2]≥35.0至≤50.0伴/不伴2型糖尿病[T2D]糖化血红蛋白[HbA1C>6.5%]),在腹腔镜辅助下,将两个线性MS磁体通过内窥镜输送到十二指肠和回肠,并对齐,启动磁体聚变和逐渐DI(MagDI)。MagDI-after-SG组先前进行了袖状胃切除术(SG);MagDISG组同时进行了SG。AE由Clavien-Dindo分类(CDC)分级。
    结果:在2021年11月22日至2023年5月30日之间,有43名患者(88.0%为女性,平均年龄43.7±1.3岁)接受研究程序。MS满足磁体装置放置的可行性标准,放射学证实的专利吻合的创造,100.0%的患者有磁铁通道。有64个AE,大部分是疾控中心一级和二级,MagDI后SG组明显较少(P<.001)。无装置相关不良事件,包括吻合口漏,出血,阻塞,感染,或死亡。MagDI后SG组的6个月平均体重减轻了8.0±2.5kg(P<0.01),17.4±5.0%过量重量损失(EWL)。MagDI+SG组的体重减轻明显更大(34.2±1.6kg,P<.001),66.2±3.4%EWL。所有T2D患者均有改善。
    结论:在多中心研究的早期结果中,无切口,无缝线磁体系统形成专利,侧对侧DI无并发症吻合与先前或同时SG。
    BACKGROUND: Conventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs).
    OBJECTIVE: The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anastomosis device (Magnet Anastomosis System [MS]).
    METHODS: Multicenter: private practices and university hospitals.
    METHODS: In patients with body mass index ([BMI, kg/m2] ≥35.0 to ≤50.0 with/without type 2 diabetes [T2D] glycosylated hemoglobin [HbA1C > 6.5 %]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating magnet fusion and gradual DI (MagDI). The MagDI-after-SG group had undergone prior sleeve gastrectomy (SG); the MagDI + SG group underwent concurrent SG. AEs were graded by Clavien-Dindo Classification (CDC).
    RESULTS: Between November 22, 2021 and May 30, 2023, 43 patients (88.0% female, mean age 43.7 ± 1.3 years) underwent the study procedures. The MS met feasibility criteria of magnet device placement, creation of patent anastomoses confirmed radiologically, and magnet passage in 100.0% of patients. There were 64 AEs, most were CDC grade I and II, significantly fewer in the MagDI-after-SG group (P < .001). No device-related AEs including anastomotic leakage, bleeding, obstruction, infection, or death. The MagDI-after-SG group experienced 6-month mean weight loss of 8.0 ± 2.5 kg (P < .01), 17.4 ± 5.0% excess weight loss (EWL). The MagDI + SG group had significantly greater weight loss (34.2 ± 1.6 kg, P < .001), 66.2 ± 3.4% EWL. All patients with T2D improved.
    CONCLUSIONS: In early results of a multicenter study, the incisionless, sutureless Magnet System formed patent, complication-free anastomoses in side-to-side DI with prior or concurrent SG.
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  • 文章类型: Multicenter Study
    背景:使用经典缝线和/或金属钉的胃肠道吻合导致大量出血和渗漏率。这项多站点研究评估了可行性,安全,以及新型线性磁压缩吻合装置的初步有效性,磁体系统(MS),以形成侧侧十二指肠回肠造口术(DI)转移,以减轻体重和2型糖尿病(T2D)。
    方法:在II级和III级肥胖患者中(体重指数[BMI,kg/m2]≥35.0-≤50.0,有/无T2D[HbA1C>6.5%]),在腹腔镜辅助下,将两个线性MS磁体通过内窥镜输送到十二指肠和回肠,并对齐,初始DI;增加袖状胃切除术(SG)。没有肠切口或保留的缝线/钉。熔融磁体自然排出。不良事件(AE)按Clavien-Dindo分类(CDC)进行分级。
    结果:2021年11月22日至2022年7月18日,24名患者(83.3%为女性,平均值±SEM重量121.9±3.3kg,BMI44.4±0.8)在三个中心接受了磁DI。磁体在中值48.5天排出。各自的平均BMI,总重量损失,和6个月时的过度体重减轻(n=24):32.0±0.8,28.1±1.0%,和66.2±3.4%;在12个月时(n=5),29.3±1.5,34.0±1.4%,80.2±6.6%。组平均各自的平均HbA1C和葡萄糖水平降至1.1±0.4%和24.8±6.6mg/dL(6个月);2.0±1.1%和53.8±6.3mg/dL(12个月)。有0个与设备相关的不良事件,3个与手术相关的严重不良事件。没有吻合口出血,泄漏,狭窄,或死亡率。
    结论:在多中心研究中,在III类肥胖的成年人中,用SG进行侧侧磁体系统十二指肠回肠造口术似乎是可行的,安全,和有效的减肥和T2D分辨率在短期内。
    Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.
    In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC).
    Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality.
    In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.
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  • 文章类型: Journal Article
    背景:微创代谢/减肥手术(MBS)可以通过磁性压缩吻合(MCA)技术进一步推进。该研究旨在开发一种大小大小的磁铁,以创建专利十二指肠回肠造口术(DI),并在猪模型中验证其有效性。
    方法:发展研究阶段:对具有4种不同法兰偏移尺寸的磁体进行了测试,以确定将成功形成压缩吻合的设计。验证阶段:评估选定设计的功效。在每个为期6周的阶段(4只猪/阶段),在空肠腹腔镜下插入一块磁铁,一个在胃镜下放置在十二指肠中。磁铁对齐,逐渐融合,形成吻合,然后离开并被驱逐。尸检时,收集并比较MCA部位和缝合肠切开术部位。
    结果:发展阶段:选择了具有2.3mm法兰偏置设计的线性BC42磁体。验证阶段:在4个猪磁铁配对在目标位置,影像学证实。磁体脱离的平均时间16.0天(12-22),驱逐24.5天(17-33)。所有动物在处死时都实现了MCA。动物平均增加9.5kg(3.9-11.8)。与缝合肠切开术相比,标本显示吻合口≥20mm,粘膜光滑,炎症和纤维化最小。一头猪接受了肠系膜疝的矫正手术,没有后遗症。
    结论:在大型动物模型中,大体和组织病理学检查证实,线性MCA装置创造了一项专利,血管化良好,十二指肠回肠吻合术。该新型MCA装置可适用于人类MBS程序。
    Minimally invasive metabolic/bariatric surgery (MBS) may be further advanced by magnetic compression anastomosis (MCA) technology. The study aimed to develop a magnet sized to create a patent duodeno-ileostomy (DI) and verify its effectiveness in a porcine model.
    Developmental study phase: magnets with 4 different flange-offset dimensions were tested to identify a design that would successfully form a compression anastomosis. Verification phase: evaluation of the selected design\'s efficacy. In each 6-week phase (4 pigs/phase), one magnet was inserted laparoscopically in the jejunum, one placed gastroscopically in the duodenum. Magnets were aligned, gradually fused, formed an anastomosis, and then detached and were expelled. At necropsy, MCA sites and sutured enterotomy sites were collected and compared.
    Developmental phase: the linear BC42 magnet with a 2.3-mm flange offset design was selected. Verification phase: in 4 swine magnets were mated at the target location, confirmed radiographically. Mean time to magnet detachment 16.0 days (12-22), to expulsion 24.5 days (17-33). MCA was achieved in all animals at time of sacrifice. Animals gained a mean 9.5 kg (3.9-11.8). Specimens revealed patent anastomoses of ≥ 20 mm with smooth mucosa and minimal inflammation and fibrosis compared to sutured enterotomies. One pig underwent corrective surgery for a mesenteric hernia without sequelae.
    In a large-animal model, gross and histopathologic examination confirmed that the linear MCA device created a patent, well-vascularized, duodeno-ileal anastomosis. The novel MCA device may be appropriate for use in human MBS procedures.
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  • 文章类型: Journal Article
    肥胖会导致发病率和死亡率的额外风险,特别是2型糖尿病(T2D)。富含亮氨酸的α2糖蛋白1(LRG1),一种新的促炎因子,最近据报道,有外周动脉疾病并发症的T2D患者的发病率更高。LRG1,肥胖,和减肥是未知的。我们检查了健康检查参与者的血浆LRG1是否与肥胖相关,以及它是否可以预测代谢/减肥手术后病态肥胖患者的未来体重减轻。
    队列1是来自三级医院的健康筛查计划(n=616)的横断面研究。队列2是对病态肥胖患者(n=231)进行的前瞻性研究,这些患者接受了代谢/减肥手术并进行了体重测量。人体测量数据,基线空腹血糖,血浆脂联素,高敏C反应蛋白(HsCRP),测量LRG1。手术后的血,代谢/减肥手术后,可用于57例患者的LRG1和HsCRP测量。
    在LRG1,体重指数(BMI)最高的组中,腰围,HsCRP明显升高,而总胆固醇,高密度脂蛋白,低密度脂蛋白,脂联素低于三分位数1和2。广义线性模型分析表明,女性性别(P<0.0001),非华裔(P<.019),和较高的HsCRP(P<0.0001)水平是较高的血浆LRG1水平的独立且显着的决定因素。调整后的年龄,性别,种族,和基线BMI,女性(P=.020),术前BMI较高(P=.001),和较低的术前LRG1(P=0.002)仍然是更大的体重减轻的统计学显著预测因子。血浆LRG1在1.5个月内显著增加[从28.2(21.9-36.8)到34.9(22.6-49.5)]μg/mL(P=.003),代谢/减肥手术后。
    我们的研究表明,LRG1水平与肥胖呈正相关,较低的血浆LRG1水平预测代谢/减肥手术中的体重减轻。我们的新发现表明LRG1本身或与其他已知因素的组合,是炎症和肥胖的潜在生物标志物。
    Obesity confers substantial excess risk for morbidity and mortality, especially for type 2 diabetes (T2D). Leucine-rich-α2-glycoprotein 1 (LRG1), a novel proinflammatory factor, was recently reported to be higher in patients with T2D with complications of peripheral arterial disease. Association of LRG1, obesity, and weight loss is unknown. We examined whether plasma LRG1 is associated with obesity in health screening participants and if it predicts future weight loss in morbidly obese patients after metabolic/bariatric surgery.
    Cohort 1 was a cross-sectional study from a Health Screening program (n = 616) in a tertiary hospital. Cohort 2 was a prospective study of morbidly obese patients (n = 231) who underwent metabolic/bariatric surgery with follow-up weight measurements. Anthropometric data, baseline fasting glucose, plasma adiponectin, high sensitivity C-reactive protein (HsCRP), and LRG1 were measured. Postsurgery blood, after metabolic/bariatric surgery, were available for LRG1and HsCRP measurements in 57 patients.
    In the group with highest tertile of LRG1, body mass index (BMI), waist circumference, and HsCRP were significantly higher, while total cholesterol, high-density lipoprotein, low-density lipoprotein, and adiponectin were lower than tertiles 1 and 2. Generalized linear model analysis showed that female gender (P < .0001), non-Chinese ethnicity (P < .019), and higher HsCRP (P < .0001) levels were independent and significant determinants of higher plasma LRG1 levels. After adjustment for age, gender, ethnicity, and baseline BMI, female gender (P = .020), higher presurgery BMI (P = .001), and lower presurgery LRG1 (P = .002) remained statistically significant predictors for greater weight loss. Plasma LRG1 increased significantly [from 28.2 (21.9-36.8) to 34.9 (22.6-49.5)] μg/mL (P = .003) within 1.5 months, after metabolic/bariatric surgery.
    Our study demonstrates that LRG1 level is positively associated with obesity and a lower level of plasma LRG1 predicts weight loss in metabolic/bariatric surgery. Our novel findings suggest LRG1, itself or in combination with other known factors, is a potential biomarker of inflammation and obesity.
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