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

Mengyi Li, Yang Liu, Wei-Jei Lee, Scott A Shikora, Maud Robert, Weu Wang, Simon Kin Hung Wong, Yuanyuan Kong, Daniel King Hung Tong, Chun Hai Tan, Na Zeng, Shaihong Zhu, Cunchuan Wang, Pin Zhang, Yan Gu, Rixing Bai, Fanqiang Meng, Zhongqi Mao, Xiangwen Zhao, Liangping Wu, Yanjun Liu, Songhai Zhang, Peng Zhang, Zhongtao Zhang, Mengyi Li, Yang Liu, Wei-Jei Lee, Scott A Shikora, Maud Robert, Weu Wang, Simon Kin Hung Wong, Yuanyuan Kong, Daniel King Hung Tong, Chun Hai Tan, Na Zeng, Shaihong Zhu, Cunchuan Wang, Pin Zhang, Yan Gu, Rixing Bai, Fanqiang Meng, Zhongqi Mao, Xiangwen Zhao, Liangping Wu, Yanjun Liu, Songhai Zhang, Peng Zhang, Zhongtao Zhang

Abstract

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.

Keywords: Clinical trials; DIABETES & ENDOCRINOLOGY; SURGERY.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1
Figure 1
The ORDER trial flowchart. ORDER, One anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 Diabetes Remission; OAGB, one anastomosis gastric bypass; RYGB, Roux-en-Y gastric bypass.

References

    1. Rubino F, Nathan DM, Eckel RH, et al. . Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by international diabetes organizations. Diabetes Care 2016;39:861–77. 10.2337/dc16-0236
    1. Schauer PR, Bhatt DL, Kirwan JP, et al. . Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med 2017;376:641–51. 10.1056/NEJMoa1600869
    1. Mingrone G, Panunzi S, De Gaetano A, et al. . Bariatric-metabolic surgery versus conventional medical treatment in obese patients with type 2 diabetes: 5 year follow-up of an open-label, single-centre, randomised controlled trial. Lancet 2015;386:964–73. 10.1016/S0140-6736(15)00075-6
    1. Courcoulas AP, Belle SH, Neiberg RH, et al. . Three-Year outcomes of bariatric surgery vs lifestyle intervention for type 2 diabetes mellitus treatment: a randomized clinical trial. JAMA Surg 2015;150:931–40. 10.1001/jamasurg.2015.1534
    1. Li M, Zeng N, Liu Y, et al. . The choice of gastric bypass or sleeve gastrectomy for patients stratified by diabetes duration and body mass index (BMI) level: results from a national registry and meta-analysis. Obes Surg 2021;31:3975–89. 10.1007/s11695-021-05459-x
    1. Lee W-J, Yu P-J, Wang W, et al. . Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg 2005;242:20–8. 10.1097/01.sla.0000167762.46568.98
    1. Lee W-J, Ser K-H, Lee Y-C, et al. . Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg 2012;22:1827–34. 10.1007/s11695-012-0726-9
    1. Disse E, Pasquer A, Espalieu P, et al. . Greater weight loss with the omega loop bypass compared to the Roux-en-Y gastric bypass: a comparative study. Obes Surg 2014;24:841–6. 10.1007/s11695-014-1180-7
    1. Robert M, Espalieu P, Pelascini E, et al. . Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet 2019;393:1299–309. 10.1016/S0140-6736(19)30475-1
    1. Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg 2001;11:276–80. 10.1381/096089201321336584
    1. Jia D, Tan H, Faramand A, et al. . One anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity: a systematic review and meta-analysis of randomized clinical trials. Obes Surg 2020;30:1211–8. 10.1007/s11695-019-04288-3
    1. Magouliotis DE, Tasiopoulou VS, Tzovaras G. One anastomosis gastric bypass versus Roux-en-Y gastric bypass for morbid obesity: an updated meta-analysis. Obes Surg 2019;29:2721–30. 10.1007/s11695-019-04005-0
    1. Lee W-J, Almalki OM, Ser K-H, et al. . Randomized controlled trial of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity: comparison of the YOMEGA and Taiwan studies. Obes Surg 2019;29:3047–53. 10.1007/s11695-019-04065-2
    1. Soong T-C, Lee M-H, Lee W-J, et al. . One anastomosis gastric bypass for the treatment of type 2 diabetes: long-term results and recurrence. Obes Surg 2021;31:935–41. 10.1007/s11695-020-05093-z
    1. Almuhanna M, Soong T-C, Lee W-J, et al. . Twenty years' experience of laparoscopic 1-anastomosis gastric bypass: surgical risk and long-term results. Surg Obes Relat Dis 2021;17:968–75. 10.1016/j.soard.2021.01.010
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. Schauer PR, Kashyap SR, Wolski K, et al. . Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med 2012;366:1567–76. 10.1056/NEJMoa1200225
    1. O'Kane M, Parretti HM, Hughes CA, et al. . Guidelines for the follow-up of patients undergoing bariatric surgery. Clin Obes 2016;6:210–24. 10.1111/cob.12145
    1. De Luca M, Piatto G, Merola G, et al. . IFSO update position statement on one anastomosis gastric bypass (OAGB). Obes Surg 2021;31:3251–78. 10.1007/s11695-021-05413-x
    1. Lee W-J, Chong K, Lin Y-H, et al. . Laparoscopic sleeve gastrectomy versus single anastomosis (mini-) gastric bypass for the treatment of type 2 diabetes mellitus: 5-year results of a randomized trial and study of incretin effect. Obes Surg 2014;24:1552–62. 10.1007/s11695-014-1344-5
    1. Nabil TM, Khalil AH, Mikhail S, et al. . Conventional versus distal laparoscopic one-Anastomosis gastric bypass: a randomized controlled trial with 1-year follow-up. Obes Surg 2019;29:3103–10. 10.1007/s11695-019-03991-5
    1. Elgeidie A, Abdelgawad M, El Sorogy M, et al. . The effect of stoma size on the mid-term weight loss outcome of one anastomosis gastric bypass (OAGB): a single-blinded prospective randomized trial. Surg Endosc 2021;35:1691–5. 10.1007/s00464-020-07553-0
    1. Shivakumar S, Tantia O, Goyal G, et al. . LSG vs MGB-OAGB-3 Year Follow-up Data: a Randomised Control Trial. Obes Surg 2018;28:2820–8. 10.1007/s11695-018-3255-3
    1. Darabi S, Talebpour M, Zeinoddini A, et al. . Laparoscopic gastric plication versus mini-gastric bypass surgery in the treatment of morbid obesity: a randomized clinical trial. Surg Obes Relat Dis 2013;9:914–9. 10.1016/j.soard.2013.07.012
    1. Seetharamaiah S, Tantia O, Goyal G, et al. . LSG vs OAGB-1 Year Follow-up Data-a Randomized Control Trial. Obes Surg 2017;27:948–54. 10.1007/s11695-016-2403-x
    1. Ospanov O, Buchwald JN, Yeleuov G, et al. . Laparoscopic one-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP): a randomized controlled trial. Obes Surg 2019;29:4131–7. 10.1007/s11695-019-04236-1
    1. De Luca M, Tie T, Ooi G, et al. . Mini gastric bypass-one anastomosis gastric bypass (MGB-OAGB)-IFSO position statement. Obes Surg 2018;28:1188–206. 10.1007/s11695-018-3182-3
    1. Parikh M, Eisenberg D, Johnson J, et al. . American Society for metabolic and bariatric surgery review of the literature on one-anastomosis gastric bypass. Surg Obes Relat Dis 2018;14:1088–92. 10.1016/j.soard.2018.04.017
    1. Mahawar KK. Findings of YOMEGA trial need to be interpreted with caution. Obes Surg 2019;29:2616–7. 10.1007/s11695-019-03856-x
    1. Almalki OM, Soong T-C, Lee W-J, et al. . Variation in small bowel length and its influence on the outcomes of sleeve gastrectomy. Obes Surg 2021;31:36–42. 10.1007/s11695-020-04958-7

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren