Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study

BackgroundThe long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented.ObjectivesTo determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives.SettingNine academic and/or private institutions.MethodsThe participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires.ResultsThe reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was ?7.01 ± 5.45 kg/m² at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures.ConclusionNo new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.     

Reversal to normal anatomy after one-anastomosis/mini gastric bypass,indications and results: a systematic review and meta-analysis

This review evaluates the indications and outcomes of one-anastomosis/mini gastric bypass (OAGB/MGB) reversal to normal anatomy. A systematic literature search and meta-analysis was performed in PubMed, Web of Science, and Scopus for articles published by October 1, 2020, including the keywords “one anastomosis gastric bypass,” “OAGB,” “mini gastric bypass,” “MGB,” “reversal,” “reverse,” “malnutrition,” and “reversal bariatric surgery”. After examining 182 papers involving 11,578 patients, 14 studies were included. A reversal was performed in 119 patients on average 23.6 months after the primary OAGB/MGB surgery. The mean body mass index (BMI) was 22.92 ± 3.47 kg/m² and the mean albumin level was 25.17 ± 4.21 g/L at reversal. The mean length of the common channel (CC) was 383.57 ± 159.35 cm, with a mean biliopancreatic limb (BPL) length of 214.21 ± 48.45 cm. Pooled estimation of the meta-analysis of prevalence studies reported a prevalence of 1% for reversal. The major signs and symptoms of protein-energy malnutrition were the leading causes of the reversal of OAGB/MGB. Bleeding, leakage, and death due to severe liver failure were the most reported complications after reversal, with an overall incidence of 10.9%. In conclusion, OAGB/MGB reversal has a prevalence of 1% and has a complication rate of 10.9%. Protein-energy malnutrition with hypoalbuminemia was the most common etiology. The mean lengths of BPL and CC were reported as 215 cm and 380 cm, respectively, in the cases. Therefore, special attention should be paid to malnutrition in all OAGB/MGB patients during follow-up to prevent severe malnutrition and subsequent increase in reversal procedures.     

The influence of preoperative carbohydrate loading on postoperative outcomes in bariatric surgery patients: a randomized,controlled trial

BackgroundPreoperative carbohydrate loading is a component of Enhanced Recovery After Surgery (ERAS) protocols, but there is limited literature in bariatric surgery patients.ObjectivesThe objective of this study was to characterize the impact of preoperative carbohydrate loading on postoperative bariatric surgery outcomes.SettingUniversity Hospital.MethodsPatients undergoing a primary minimally invasive Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between 2018 and 2020 were randomized to standard management or intervention. Standard management patients were nothing by mouth (NPO) after midnight prior to surgery. Intervention patients consumed 2 carbohydrate drinks: 1 the night before and another 3 hours prior to surgery. Primary outcomes analyzed included postoperative nausea and vomiting (PONV), length of stay, and overall complications.ResultsIn total, 134 patients were analyzed: 64 intervention (47.8%) and 70 (52.2%) standard. In the end, 7% and 15% of patients were lost to follow-up at 6-weeks and 3-months, respectively. There was no statistically significant difference in length of stay (2.0 ± 1.2 vs 2.1 ± .9 d; P = .65) or postoperative outcomes between the 2 groups. There were no episodes of aspiration among the intervention group. Among RYGB patients, intervention patients had a shorter duration of nausea compared with standard patients. There was no significant difference in glycemic control among patients with and without diabetes.ConclusionsPreoperative carbohydrate drinks can be administered to bariatric surgery patients without significant risks. Carbohydrate loading preoperatively can decrease the duration of PONV in RYGB patients. Carbohydrate drinks can be safely included in bariatric ERAS protocols for patients with and without diabetes, although the benefits remain unknown.     

Postbariatric hypoglycemia: symptom patterns and associated risk factors in the Longitudinal Assessment of Bariatric Surgery study

BackgroundPostbariatric hypoglycemia (PBH) can be a devastating complication for which current therapies are often incompletely effective. More information is needed regarding frequency, incidence, and risk factors for PBH.ObjectivesTo examine hypoglycemia symptoms following Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) and baseline and in-study risk factors.SettingMulticenter, at 10 US hospitals in 6 geographically diverse clinical centers.MethodsA prospective, longitudinal cohort study of adults undergoing RYGB or LAGB as part of clinical care between 2006 and 2009 were recruited and followed until January 31, 2015, with baseline and annual postoperative research assessments. We analyzed baseline prevalence and post-operative incidence and frequency of self-reported hypoglycemia symptoms as well as potential preoperative risk factors.ResultsIn all groups, postoperative prevalence of hypoglycemia symptoms was 38.5%. Symptom prevalence increased postoperatively from 2.8%–36.4% after RYGB in patients without preoperative diabetes (T2D), with similar patterns in prediabetes (4.9%–29.1%). Individuals with T2D had higher baseline hypoglycemia symptoms (28.9%), increasing after RYGB (57.9%). Hypoglycemia symptoms were lower after LAGB, with 39.1% reported hypoglycemia symptoms at only 1 postoperative visit with few (4.0%) having persistent symptoms at 6 or more annual visits. Timing of symptoms was not restricted to the postprandial state. Symptoms of severe hypoglycemia were reported in 2.6–3.6% after RYGB. The dominant risk factor for postoperative symptoms was preoperative symptoms; additionally, baseline selective serotonin (SSRI) and serotonin-norepinephrine (SNRI) reuptake inhibitor use was also associated with increased risk in multivariable analysis. Weight loss and regain were not related to hypoglycemia symptom reporting.ConclusionHypoglycemia symptoms increase over time after RYGB, particularly in patients without diabetes. In a small percentage, symptoms can be persistent or severe and require hospitalization. Preoperative hypoglycemia symptoms and SSRI/SNRI use in RYGB patients without diabetes is associated with increased risk of symptoms.     

外周血单个核细胞TLR3信号通路活化在重组乙型肝炎表面抗原免疫应答中的作用

目的探讨外周血单个核细胞(PBMC)Toll样受体3(TLR3)信号通路的活化在重组HBsAg(rHBsAg)免疫应答中的作用及机制。方法收集13名健康献血者外周血制备血液制品时滤除的白细胞, 分离培养PBMC后分别给予TLR3激动剂聚肌苷酸-聚胞苷酸(Poly I:C组)及PBS(对照组)处理, 48 h后收集部分细胞, 采用流式细胞术检测TLR3信号通路蛋白水平;在活化(Poly I:C组)/未活化(对照组)TLR3信号通路后, 采用rHBsAg处理两组PBMC 72 h, 采用流式细胞术检测PBMC中树突状细胞(DC)、T、B淋巴细胞及其亚群比例。采用配对t检验、配对资料的符号秩和检验和典型相关分析进行统计学分析。结果 Poly I:C组PBMC TLR3信号通路中TLR3蛋白阳性细胞百分比(19.21%)、TLR3蛋白表达量(8 983.95)、NF-κB蛋白的表达量(26 193.13)、磷酸化NF-κB(pNF-κB)蛋白阳性细胞百分比(13.73%)及其占NF-κB的比例(16.03%)、磷酸化IRF3(pIRF3)蛋白阳性细胞百分比(12.64%)及其占IRF3的比例(...     

Exploration of the association between serum uric acid and testosterone in adult males: NHANES 2011–2016

BackgroundPrevious studies have suggested that the possible relationship between serum uric acid (SUA) and testosterone. However, the results of previous studies are controversial and there is limited evidence examining the relationship between SUA and testosterone in a general US population of men. The objective of this study is to explore the correlation of SUA and testosterone among adult males from the US.MethodsData from the National Health and Nutrition Examination Survey 2011–2016 were used, including a total of 7,796 male participants aged 18 years or older and excluding those lacking serum testosterone and uric acid data. Clinical characteristics of the participants among different SUA groups and testosterone groups are compared. Univariate and multivariate linear regression analyses were applied to evaluate the association between SUA and testosterone.ResultsWe found an inverse association between SUA and testosterone after fully adjusted the potential confounding factors in general US adult males. In the multivariate linear regression analysis, we found that increasing age (estimate testosterone percent difference: −0.20% per year, P<0.01), uric acid (estimate testosterone percent difference: −4.40% per md/dL, P<0.01) and BMI (estimate testosterone percent difference: −2.86% per kg/m2, P<0.01) were associated with declining serum testosterone. This association remained significant in sensitivity analysis, while in the stratified analysis, above association was not significant in men with diabetes or aged 65 and over.ConclusionsSUA levels might be negatively associated with serum testosterone in adult males.     

Laparoscopic resection for a large gastrointestinal stromal tumor (GIST) with diaphragm invasion following preoperative imatinib treatment: A case report

IntroductionNeoadjuvant imatinib for large GISTs may prevent tumor rupture and the need for extended surgery by reducing tumor size. In this study, we present a case of large gastric GIST with diaphragm invasion, due to the patient receiving laparoscopic resection following preoperative imatinib treatment.Presentation of caseA 72-year-old woman was hospitalized with left hypochondriac pain for a month. Examinations revealed a large heterogeneous gastric mass measuring 80 mm in size, arising from the greater curvature of the corpus. The mass invaded the left thoracic diaphragm. Treatment with imatinib at an initial dosage of 400 mg/day was initiated. After a further two months of follow-up, the lesion had sustained reduction to 50 mm in size, however, the invasion to the diaphragm remained. The patient eventually underwent laparoscopic partial gastrectomy and partial resection of the diaphragm with curative intent. Adjuvant chemotherapy was initiated at one month after the surgery, however, was discontinued due to nausea. After one-year follow-up, no recurrence was noted.DiscussionNeoadjuvant imatinib may shrink tumor size remarkably and prevent tumor rupture during surgery, and thus lead to increased rates of complete resection. To date, several publications have directly compared the oncologic results between laparoscopic and open resection for GISTs. In the present case, the tumor was movable, and moderately fixed on diaphragm. It was favorable condition for laparoscopic surgery.ConclusionsThis is the first report of a large gastric GIST invading the diaphragm that was successfully treated by laparoscopic resection after tumor reduction by neoadjuvant imatinib.     

上海市松江区成年人高尿酸血症与慢性肾病关系的队列研究

目的 分析社区成年人高尿酸血症（HUA）与慢性肾病（CKD）发病风险的关系。方法 基于华东区域自然人群队列,对7 276例基线时未患CKD的上海市松江区20~74岁常住居民进行基于社区的前瞻性队列研究。CKD的诊断根据美国肾脏基金会慢性肾脏病实践指南的标准,HUA定义为血清尿酸（SUA）>420 μmol/L（男性）或>360 μmol/L（女性）。采用Cox比例风险模型分析HUA与CKD发病风险的关联。结果 经过中位时间2.65年的随访,队列人群新发CKD病例301例,累积发病率为4.14%,发病密度为16.01/1 000人年（95% CI：14.20~17.82）。CKD发病人群HUA的基线患病率显著高于非CKD发病人群。多因素Cox回归分析显示,HUA与CKD发病风险呈显著正关联,HUA患者的CKD发病风险HR值为1.92（95% CI：1.46~2.53）。在对性别、年龄、BMI、2型糖尿病、高血压等因素分层后,HUA与CKD发病风险仍呈显著正关联;在相加模型中,年龄与HUA存在交互作用,交互作用指数为1.78（95% CI：1.18~2.68）。结论 上海市松江区成年人CKD的发病率较高,HUA为CKD发病的独立危险因素。