Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial

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Abstract 1.1 Background Obesity is a serious disease with a significant negative impact on global health. Bariatric metabolic surgery is an effective treatment option. Jejuno-ileal diversion (JID, side-to-side anastomosis between jejunum and ileum) and jejuno-colic diversion (JCD, side-to-side anastomosis between jejunum and transverse colon) are novel techniques in bariatric surgery. Evidence from other intestinal bypasses suggests positive effects on energy metabolism, bile acid circulation, satiety hormones, and insulin sensitivity. However, robust data on JID and JCD are limited, particularly regarding long-term outcomes, safety, and mechanisms of action. Comparative studies are scarce, creating an important gap in knowledge that must be addressed to define their role in bariatric practice. 1.2 Methods/Design This is a prospective randomised clinical trial. Study subjects who meet the Inclusion criteria and baseline procedures undergo surgery: first 40 patients JID / next 40 patients JCD. In addition, both arms (JID, JCD) will be divided into diabetic and non-diabetic groups and these groups will be compared within each respective arm. The subject will have follow-up clinic visits at Weeks 1, 2, and 3 and at Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 after the procedure. At each visit, the subject will undergo a review of medical history, evaluation of adverse events, physical examination, blood sampling. At specific intervals, mixed-meal tolerance test will be performed. Upper gastrointestinal (GI) series radiographic studies will be performed at baseline and 14 days after the procedure, focussing on the patency of the anastomosis. 1.3 Discussion This study will address the current evidence gap on intestine-preserving bariatric techniques. If effective, JID and JCD could offer a surgical option with sustained metabolic benefits, preserved intestinal continuity, and potentially fewer long-term complications compared to existing bariatric procedures. 1.4 Trial Registration ClinicalTrials.gov NCT06374368. Registered on 02/2021. 1.5 Status of trial Protocol trial version 1.0, dated 15.3.2019. Recruiting since 2019, expected to complete 2028.
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Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial Marek Buzga, Pavol Holeczy, Zdenek Svagera, Petr Svoboda, Vojtech Skop, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7404898/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 3 You are reading this latest preprint version Abstract 1.1 Background Obesity is a serious disease with a significant negative impact on global health. Bariatric metabolic surgery is an effective treatment option. Jejuno-ileal diversion (JID, side-to-side anastomosis between jejunum and ileum) and jejuno-colic diversion (JCD, side-to-side anastomosis between jejunum and transverse colon) are novel techniques in bariatric surgery. Evidence from other intestinal bypasses suggests positive effects on energy metabolism, bile acid circulation, satiety hormones, and insulin sensitivity. However, robust data on JID and JCD are limited, particularly regarding long-term outcomes, safety, and mechanisms of action. Comparative studies are scarce, creating an important gap in knowledge that must be addressed to define their role in bariatric practice. 1.2 Methods/Design This is a prospective randomised clinical trial. Study subjects who meet the Inclusion criteria and baseline procedures undergo surgery: first 40 patients JID / next 40 patients JCD. In addition, both arms (JID, JCD) will be divided into diabetic and non-diabetic groups and these groups will be compared within each respective arm. The subject will have follow-up clinic visits at Weeks 1, 2, and 3 and at Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 after the procedure. At each visit, the subject will undergo a review of medical history, evaluation of adverse events, physical examination, blood sampling. At specific intervals, mixed-meal tolerance test will be performed. Upper gastrointestinal (GI) series radiographic studies will be performed at baseline and 14 days after the procedure, focussing on the patency of the anastomosis. 1.3 Discussion This study will address the current evidence gap on intestine-preserving bariatric techniques. If effective, JID and JCD could offer a surgical option with sustained metabolic benefits, preserved intestinal continuity, and potentially fewer long-term complications compared to existing bariatric procedures. 1.4 Trial Registration ClinicalTrials.gov NCT06374368. Registered on 02/2021. 1.5 Status of trial Protocol trial version 1.0, dated 15.3.2019. Recruiting since 2019, expected to complete 2028. Obesity type 2 diabetes partial jejuno-ileal diversion partial jejuno-colic diversion side-to-side anastomosis bariatric surgery metabolic surgery. Full Text Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 23 Dec, 2025 Editor assigned by journal 18 Sep, 2025 First submitted to journal 18 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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