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
Yang Liu,
Peng Zhang,
Yuanyuan Kong,
Yan Gu,
Maud Robert,
Cunchuan Wang,
Zhongtao Zhang,
Mengyi Li,
Wei-Jei Lee,
Scott A Shikora,
Weu Wang,
Simon Kin Hung Wong,
Daniel King Hung Tong,
Chun Hai Tan,
Na Zeng,
Shaihong Zhu,
Pin Zhang,
Rixing Bai,
Fanqiang Meng,
Zhongqi Mao,
Xiangwen Zhao,
Liangping Wu,
Yanjun Liu,
Songhai Zhang
Affiliations
Yang Liu
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Peng Zhang
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Yuanyuan Kong
Clinical Epidemiology & EBM Unit, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Yan Gu
Department of General Surgery, Huadong Hospital Affiliated to Fudan University, Shanghai, China
Maud Robert
Department of Digestive and Bariatric Surgery, Hôpital Edouard Herriot, Lyon, France
Cunchuan Wang
Department of Gastrointestinal Surgery, The First Affiliated Hospital of Jinan University, Guangdong, China
Zhongtao Zhang
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Mengyi Li
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Wei-Jei Lee
Department of Surgery, Min-Sheng General Hospital, Taiwan, China
Scott A Shikora
Department of Surgery, Brigham and Women`s Hospital, Boston, Massachusetts, USA
Weu Wang
Department of Surgery, Taipei Medical University Hospital, Taiwan, China
Simon Kin Hung Wong
Department of Surgery, Prince of Wales Hospital, Hong Kong SAR, China
Daniel King Hung Tong
Surgery Center, Hong Kong Sanatorium & Hospital, Hong Kong SAR, China
Chun Hai Tan
Surgicare Bariatric and General Surgery Clinic, Singapore
Na Zeng
School of Public Health, Peking University, Beijing, China
Shaihong Zhu
Department of General Surgery, The Third Xiangya Hospital of Central South University, Hunan, China
Pin Zhang
Division of Bariatric and Metabolic Surgery, Department of General Surgery, Shanghai Jiao Tong University affiliated Sixth People’s Hospital, Shanghai, China
Rixing Bai
Department of General Surgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Fanqiang Meng
Department of General Surgery, China-Japan Friendship Hospital, Beijing, China
Zhongqi Mao
Department of General Surgery, The First Affiliated Hospital of Soochow University, Jiangsu, China
Xiangwen Zhao
Department of General Surgery, Xiaolan People’s Hospital, Guangdong, China
Liangping Wu
Division of Metabolic and Bariatric Surgery, Department of General Surgery, Jinshazhou Hospital of Guangzhou, University of Chinese Medicine, Guangdong, China
Yanjun Liu
Center of Gastrointestinal and Minimally Invasive Surgery, Department of General Surgery, The Third People’s Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University & Research Center for Obesity and Metabolic Disease, School of Medicine, Southwest Jiaotong University, Sichuan, China
Songhai Zhang
Department of General Surgery, The First Affiliated Hospital of Henan University of Science and Technology, Henan, China
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05015283.
