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Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial

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收录情况： ◇ SCIE

作者：
Li Mengyi[1] * ; Liu Yang[1] * ; Lee Wei-Jei[2] ; Shikora Scott A[3] ; Robert Maud[4] ; Wang Weu[5] ; Wong Simon Kin Hung[6] ; Kong Yuanyuan[7] ; Tong Daniel King Hung[8] ; Tan Chun Hai[9] ; Zeng Na[10] ; Zhu Shaihong[11] ; Wang Cunchuan[12] ; Zhang Pin[13] ; Gu Yan[14] ; Bai Rixing[15] ; Meng Fanqiang[16] ; Mao Zhongqi[17] ; Zhao Xiangwen[18] ; Wu Liangping[19] ; Liu Yanjun[20] ; Zhang Songhai[21] ; Zhang Peng[1] ; Zhang Zhongtao[1] ;
机构： [1]Department of General Surgery, Beijing Friendship Hospital, Capital MedicalUniversity, Beijing, China [2]Department of Surgery, Min-ShengGeneral Hospital, Taiwan, China [3]Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts,USA [4]Department of Digestive and Bariatric Surgery, Hôpital Edouard Herriot, Lyon,France [5]Department of Surgery, Taipei Medical University Hospital, Taiwan, China [6]Department of Surgery, Prince of Wales Hospital, Hong Kong SAR, China [7]Clinical Epidemiology & EBM Unit, Beijing Friendship Hospital, Capital MedicalUniversity, Beijing, China [8]Surgery Center, Hong Kong Sanatorium & Hospital, Hong Kong SAR, China [9]Surgicare Bariatric and General Surgery Clinic, Singapore [10]School of Public Health, Peking University, Beijing, China [11]Department of General Surgery, The Third Xiangya Hospital of Central SouthUniversity, Hunan, China [12]Department of Gastrointestinal Surgery, The First Affiliated Hospital of JinanUniversity, Guangdong, China [13]Division of Bariatric and Metabolic Surgery, Department of General Surgery,Shanghai Jiao Tong University affiliated Sixth People’s Hospital, Shanghai, China [14]Department of General Surgery, Huadong Hospital Affiliated to Fudan University,Shanghai, China [15]Department of General Surgery, Beijing Tiantan Hospital, Capital MedicalUniversity, Beijing, China [16]Department of General Surgery, China-JapanFriendship Hospital, Beijing, China [17]Department of General Surgery, The First Affiliated Hospital of Soochow University,Jiangsu, China [18]Department of General Surgery, Xiaolan People’s Hospital, Guangdong, China [19]Division of Metabolic and Bariatric Surgery, Department of General Surgery,Jinshazhou Hospital of Guangzhou, University of Chinese Medicine, Guangdong,China [20]Center of Gastrointestinal and Minimally Invasive Surgery, Department of GeneralSurgery, The Third People’s Hospital of Chengdu, Affiliated Hospital of SouthwestJiaotong University & Research Center for Obesity and Metabolic Disease, School ofMedicine, Southwest Jiaotong University, Sichuan, China [21]Department of General Surgery, The First Affiliated Hospital of Henan University ofScience and Technology, Henan, China
出处：
DOI： 10.1136/bmjopen-2022-062206
ISSN：

摘要：
Previous studies have demonstrated that one anastomosis gastric bypass (OAGB) is not inferior to Roux-en-Y gastric bypass (RYGB) in treating obesity. However, high level evidence comparing the efficacy and safety of both procedures in type 2 diabetes (T2D) treatment is still lacking, which is another main aim of bariatric surgery. The presented trial has been designed to aim at investigating the superiority of OAGB over the reference procedure RYGB in treating T2D as primary endpoint. And diabetes-related microvascular and macrovascular complications, cardiovascular comorbidities, weight loss, postoperative nutritional status, quality of life and overall complications will be followed up for 5 years as secondary endpoints.This prospective, multicentre, randomised superiority open-label trial will be conducted in patients of Asian descent. A total of 248 patients (BMI≥27.5 kg/m2) who are diagnosed with T2D will be randomly assigned (1:1) to OAGB or RYGB with blocks of four. The primary endpoint is the complete diabetes remission rate defined as HbA1c≤6.0% and fasting plasma glucose≤5.6 mmol/L without any antidiabetic medications at 1 year after surgery. All secondary endpoints will be measured at different follow-up visit points, which will start at least 3 months after enrolment, with a continuous annual follow-up for five postoperative years in order to provide solid evidence on the efficacy and safety of OAGB in patients with T2D.The study has been approved by the ethics committee of leading centre (Beijing Friendship Hospital, Capital Medical University, no. 2021-P2-037-03). The results generated from this work will be disseminated to academic audiences and the public via publications in international peer-reviewed journals and conferences. The data presented will be imported into a national data registry. Findings are expected to be available in 2025, which will facilitate clinical decision-making in the field.NCT05015283.© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

基金：
This work is supported by Beijing Municipal Science & Technology Commission (Z211100002921029), National Key Technologies R&D Programme (2015BAI13B09), Beithune Charitable Foundation (DXWKYJ001) and Beijing Excellent Talents Training Funding Programme (2018000021469G195).
语种：
外文
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中科院(CAS)分区：
出版当年[2021]版：
大类 | 4 区 医学
小类 | 3 区 医学：内科
最新[2025]版：
大类 | 4 区 医学
小类 | 4 区 医学：内科
JCR分区：
出版当年[2020]版：
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Department of General Surgery, Beijing Friendship Hospital, Capital MedicalUniversity, Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Li Mengyi,Liu Yang,Lee Wei-Jei,et al.Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial[J].BMJ OPEN.2022,12(9):doi:10.1136/bmjopen-2022-062206.
APA：
Li Mengyi,Liu Yang,Lee Wei-Jei,Shikora Scott A,Robert Maud...&Zhang Zhongtao.(2022).Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial.BMJ OPEN,12,(9)
MLA：
Li Mengyi,et al."Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial".BMJ OPEN 12..9(2022)

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