Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) to Achieve Duodeno-Ileal Diversion in patients with Obesity: Preliminary Italian multi-center results

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) to Achieve Duodeno-Ileal Diversion in patients with Obesity: Preliminary Italian multi-center results | 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 Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) to Achieve Duodeno-Ileal Diversion in patients with Obesity: Preliminary Italian multi-center results Sonja Chiappetta, Paolo Gentileschi, Stefano Olmi, Giovanni Cesena, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7519191/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 25 Nov, 2025 Read the published version in Obesity Surgery → Version 1 posted 8 You are reading this latest preprint version Abstract Background Linear magnetic compression is a novel technique to perform gastrointestinal anastomosis. Objective This Italian multi-center clinical investigation aimed to evaluate the feasibility, safety and efficacy of the creation of a side-to-side compression anastomosis using the GT Metabolic Solutions™ Magnet System, DI Biofragmentable (MagDI™ System) to achieve duodeno-ileal diversion. Methods Patients with a body mass index (BMI) of ≥ 30 to 50 kg/m 2 and weight regain and/or type 2 diabetes mellitus (T2DM) after sleeve gastrectomy (SG) and patients with a BMI of ≥ 30 to 35 kg/m 2 and T2DM underwent a side-to-side duodeno-ileal diversion using the GT Metabolic™ DI Magnet (linear, 39mm). Results 28 patients (19F) underwent surgery in 4 centers in the time between 09/24 and 02/25. Mean age and BMI were 44 years and 36.7 ± 4.4 kg/m 2 . Mean operative time and hospital stay were 73.2 minutes and 1.6 days. Paired magnets were expelled in all patients in a mean of 37.3 days. There were three procedure-related serious adverse events (Clavien Dindo III, one ileal perforation on POD 1, one liver insufficiency leading to reversal on POD 144 and one trocar site hernia on POD 203). Mean BMI, %EWL and %TWL at 90 days (n = 23) were 32.7 ± 0.8 kg/m 2 , 36.6 ± 4.6% and 10.4 ± 1.1%. Mean HbA1c decreased from 6% at baseline to 5.7% at 30 days and to 5.5% at 90 days. Conclusion Preliminary data shows that side-to-side magnet compression duodeno-ileal anastomosis was feasible, safe and effective. Future follow-up data is necessary. magnetic surgery magnets linear magnets revisional bariatric surgery weight regain after sleeve gastrectomy bipartition Figures Figure 1 Figure 2 Figure 3 Key Points • Side-to-side magnet compression duodeno-ileal anastomosis bipartition in weight regain after Sleeve Gastrectomy was feasible. • Side-to-side magnet compression duodeno-ileal anastomosis bipartition in weight regain after Sleeve Gastrectomy was safe. • Future Follow-Up data and future studies are necessary to understand the role of magnetic side-to-side duodeno-ileal diversion in the future. Introduction Linear magnetic compression represents an emerging technique for the creation of gastrointestinal anastomoses ( 1 , 2 ) and may, in the future, serve as an alternative to conventional sutures and metallic staples. The new concept in creating anastomoses might address surgical challenges and further reduce the risk of perioperative morbidity, mainly due to bleeding or leakage. Due to the chronic and relapsing nature of obesity, both insufficient initial response and late post-operative clinical deterioration are well-documented phenomena following metabolic and bariatric surgery (MBS). These may present as inadequate weight loss, weight regain, or recurrence and progression of obesity-related comorbidities after an initially satisfactory outcome. A multimodal approach in these patients is necessary and revisional bariatric surgery (RBS) utilizing minimally invasive surgery and transoral endoscopic techniques is a recognized therapeutic strategy ( 3 ). On the other hand it is well known, that RBS increase the risk for perioperative complications and risk stratification is of most importance in these patients ( 4 ). Sleeve Gastrectomy (SG) is the most performed MBS worldwide and therefor a high number of patients may need RBS in case of inadequate weight loss, weight regain, or recurrence and progression of obesity-related comorbidities. Guan et al. reported a revision rate of 22.6% in patients after SG with a ≥ 10-year follow-up ( 5 ). Bypass procedures such as Roux-en Y Gastric Bypass (RYGB), One anastomosis Gastric Bypass (OAGB) and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S) are well known revisional procedures after SG ( 6 ). . SG with transit bipartition ( 7 ) and Transit Bipartition after SG ( 8 ) are discussed in the current literature, due to several potential advantages: reduced surgical invasiveness, the metabolic effect of duodenal exclusion, and preservation of normal anatomy, thereby maintaining the feasibility of subsequent endoscopic procedures such as ERCP in patients with gallstone disease. Moreover, the persistence of intestinal bipartition may attenuate the risk of severe malnutrition. Magnetic side-to-side compression duodeno-ileal diversion anastomosis may offer a surgical stepforward and a less invasive surgical procedure. The present Italian multicenter clinical investigation was designed to evaluate the feasibility, safety, and efficacy of side-to-side compression anastomosis using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI™ System), to achieve duodeno-ileal diversion in patients with obesity. Methods Study Design This was a prospective, single-arm, multicenter clinical investigation (MagDI Italy Study, GTM-010 Rev.B; 03Apr2024 and Rev.2; 12Nov2024; Eudamed Number CIV-IT-23-11-044644) designed to evaluate the feasibility, safety, and preliminary efficacy of the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDIä System) for the creation of a side-to-side duodeno-ileal diversion anastomosis. The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and approved by the ethics committee and Italian Ministry of Health under authorization number 0059320-12/07/2024-DGDMF-MDS-P. The study was conducted in four Italian clinical centers: Ospedale Evangelico Betania, Naples 1 (Principal Investigator (PI) Sonja Chiappetta; n = 10); Maria Cecilia Hospital, Cotignola (Ravenna) 2 (PI Paolo Gentileschi; n = 9); Policlinico San Marco, Zingonia (Bergamo) 3 (PIs Stefano Olmi and Giovanni Cesena; n=5); and San Raffaele Scientific Institute, Milan 4 (PI Marco Anselmino; n=4). Michel Gagner from Westmount Square Surgical Center – Westmount, Quebec, Canada 5 played the role of trainer and proctor during most of the procedures. Participants Inclusion Criteria Adults (18-65 years) with obesity (BMI between 30-50 kg/m²) who had one of the following criteria were eligible: a. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous SG (≥ 12 months); OR b. T2DM (defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR c. T2DM (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous SG and no plan to perform a concurrent SG. All participants agreed to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study and all participants have been informed of the nature of the study and agreed to its provisions, complying with study required testing, medications, follow-up visits for 12 months and had provided written informed consent. Exclusion Criteria Patients were excluded if they had type 1 diabetes, required injectable insulin, or had uncontrolled T2DM. Additional exclusions included uncontrolled hypertension, dyslipidemia, or sleep apnea; previous intestinal, colonic, or duodenal surgery (other than bariatric); or conditions such as scarring, abnormal anatomy, or prior interventions that would preclude the procedure. Patients with refractory gastroesophageal reflux disease, Barrett’s esophagus, Helicobacter pylori infection, active ulcer disease, large hiatal hernia, inflammatory bowel disease, or diverticulitis were not eligible. Technical exclusions included any anomaly preventing orogastric, endoscopic, or laparoscopic access, the presence of implantable pacemakers/defibrillators, or anticipated need for MRI within two months post-procedure. Psychiatric disorders (other than well-controlled depression), history of substance abuse, pregnancy or planned pregnancy, recent tobacco/nicotine cessation (< 3 months), active infection, chronic anticoagulation (except aspirin), or known allergies to device components or contrast media also led to exclusion. Further criteria included unhealed ulcers, bleeding or neoplastic lesions at the magnet deployment site, life expectancy ≤12 months, stroke or transient ischemic attack within 6 months, or participation in another investigational study not yet at its primary endpoint. Finally, patients with COVID-19 positivity before the procedure or any other medical, anatomical, social, or psychological condition deemed unsafe or likely to interfere with follow-up were excluded. Preoperative Evaluation Baseline assessments included detailed medical history with prior and current medications, physical examination, vital signs, anthropometric measurements (weight, height, waist circumference, BMI), medical and obesity history, psychological evaluation, laboratory blood tests, and pregnancy testing when applicable. Surgical Procedure Procedures were performed under general anesthesia using a standard laparoscopic approach within 45 days of enrollment. During all the surgical procedures Michel Gagner was present in the Operating Room. Patients underwent a side-to-side duodeno-ileal diversion using a biofragmentable magnetic device, composed of paired magnets (GT Metabolicä DI Magnet; linear, 39mm). The first magnet was swallowed by the patient prior to surgery. It was then placed laparoscopically 250 cm proximal the ileocecal valve and the second magnet was delivered endoscopically to the duodenum to get aligned the two magnets and to create a magnet compression duodeno-ileal anastomosis. The mesenteric space was closed at the end of the procedure. Standard perioperative monitoring was performed. The strong magnetic attraction compressed the adjacent bowel walls (duodeno-ileostomy), inducing ischemia and tissue remodeling, which over several days resulted in the formation of a side-to-side duodeno-ileostomy. After maturation of the anastomosis, the device separated and was naturally expelled per rectum. Postoperative Management and Follow-Up Patients were monitored clinically, hemodynamically, and electrocardiographically for approximately 24 hours. On postoperative day (POD) 1, radiographic imaging was used to confirm device position and early anastomosis formation. Before discharge, patients received standardized dietary counseling with staged progression from liquids to solids under nutritional supervision. Scheduled follow-up visits occurred at Days 14, 30, 60, 90, 180, 270, and 360. Assessments included physical examination, vital signs, anthropometric measurements, laboratory tests (metabolic and nutritional parameters), and imaging until anastomosis patency and device passage were confirmed. Upper endoscopy was initially planned after magnetic expulsion at day 30, 60 or 90 and at day 180 and 360. The timepoints of upper endoscopy were revised to better align with standard of care practice at study sites to day 90 and 360 (Rev.2; 12Nov2024). All adverse events were recorded and graded according to the Clavien–Dindo classification (9). Patient-reported satisfaction questionnaires were administered at 6 and 12 months. Study objectives and endpoints The primary objective of this study was to assess the feasibility and performance of creating a side-to-side duodeno-ileal diversion using the MagDI System. Feasibility was defined as successful placement of the magnets (≥90% alignment), spontaneous passage of the magnets without surgical re-intervention, and creation of a patent anastomosis confirmed radiologically at Day 90. The primary endpoint was met if feasibility was achieved in at least 80% of enrolled and treated participants. The secondary objective was to evaluate the safety of the MagDI System. Safety was assessed by the incidence of serious adverse events related to the device or procedure requiring emergency surgery or re-intervention, including all-cause mortality, intestinal perforation or peritonitis, intestinal obstruction, life-threatening bleeding, and device malfunction. Exploratory efficacy endpoints were assessed at Days 90, 180, and 360, and included changes from baseline in weight, body mass index (BMI), percent excess weight loss (%EWL), total body weight loss (%TWL), glycemic control (HbA1c, fasting glucose), and use of antidiabetic medications. These endpoints were chosen as clinically relevant and validated measures of weight reduction, metabolic improvement, and overall therapeutic effect. Statistical Analysis This was a feasibility study with a planned sample size of up to 50 participants. No formal hypothesis testing was conducted. Data were analyzed descriptively: continuous variables are presented as means ± standard deviation or medians with interquartile ranges, and categorical variables as frequencies and percentages. Results Between September 20, 2024 and February 2nd, 2025, 28 patients (19F, 9M) underwent surgery. Mean age was 44 years, mean weight was 101.3 ± 16.8 kg (Min 73kg, Max 139) and mean BMI was 36.7 ± 4.4 kg/m 2 (Min 30 kg/m 2 , Max 45.5 kg/m 2 ). Surgery after SG was performed in 26 patients. Two patients had T2DM and class I obesity. Surgery was performed 6.3 years after SG in 15 patients. All patients swallowed the magnet without problems prior to surgery and magnetic anastomosis was achieved in 27/28 (96%) patients. Mean operative time was 73.2 +/- 27.5 minutes (min 45, max 145). Mean hospital stay was 1.6 days (range 1–3). In two patients, unplanned concomitant procedures were performed according to clinical needs: cholecystectomy and hiatoplasty in one, and adhesiolisis and umbilical hernia repair with intraperitoneal onlay mash in ombelical hernia in the other. Perioperative 30-day morbidity was 4% (1/27) and mortality was 0%. There was one possibly device-related readmission due to abdominal pain/cramps from POD 22–29 in one patient (Clavien-Dindo II). In one patient, creation of the magnetic anastomosis was not performed. Due to organizational reasons, surgery was initiated 8.5 hours after magnet ingestion, at which point the magnet was already located in the cecum. It was not possible to reposition it into the ileum because of the ileocecal valve and surgery was interrupted. Table 1 shows the different complications. There were seven procedure-related serious adverse events: In four patients intestinal serosal tears were repaired by stitches during the procedure, without sequelae. One patient presented a superficial pharyngeal lesion during endoscopic magnet placement, which healed without treatment. In one patient enterotomy was performed and sutured without consequences. One patient had a perforation in the biliopancreatic limb and was reoperated due to biliary peritonitis at POD 2. Table 1 Complications: Description Sponsor Relationship to Device Sponsor Relationship to Procedure Serious Adverse Event (SAE) Clavien-Dindo Classification Serosal tears (n = 4) during surgery Not Related Definitely Related No Grade III Nutritional – ipovitaminosis D Not Related Definitely Related No Grade II Pharyngeal lesion Not Related Definitely Related No Grade II Liver insufficiency leading to DI reversal Not Related Definitely Related Yes Grade III Nutrition - Vitamin/Mineral deficiency (B12, A, K, and Iron) Not Related Probably Related No Grade I Seroma post IPOM Not Related Indeterminate No Grade II Hernia - umbilical, trocar site Not Related Definitely Related Yes Grade III Enterotomy - Magnet placement Not Related Definitely Related No Grade III GI - Abd cramps, Pain - Abd Possibly Related Not Related No Grade II Perforation - intestinal during procedure Not Related Definitely Related Yes Grade III Choledocholithiasis with sepsis - Biliary tract clearance and cholecystectomy Not Related Not Related Yes Grade III Clavien-Dindo Classification of surgical complications : Grade I : Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Antiemetics, antipyretics, analgesics, diuretics and electro- lytes, and physiotherapy allowed. Grade II : Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition included. Grade III : Requiring surgical, endoscopic, or radiological intervention. Grade IV : Life-threatening complication (including certain central nervous system complications) requiring Intermediate Care/Intensive Care Unit-management. Grade V : Death of patient (PMID: ) There were further procedure-related serious adverse events during FU until 21.08.2025. One hypovitaminosis D on POD 33 and one hypovitaminosis of iron, B12, Vitamin A and K on POD 181. Both solved with oral vitamin substitution. Three patients were reoperated: one patient due to sepsis from acute cholecystitis in gallbladder stones (ERCP and laparoscopic cholecystectomy on POD 90), one laparoscopic reconversion to normal anatomy due to liver insufficiency (Child Pugh C) in severe malnutrition on POD 144 and one surgical trocar site hernia repair on POD 203. Figure 3 shows the duodeno-ileostomy during trocar site hernia surgery on POD 203. Paired magnets were expelled in all patients at a median of 37.3 days (min 15, max 97). Only 9 subjects were aware of magnet passage. In most cases (n = 22), X-ray on day 30 confirmed expulsion. In three patients expulsion was confirmed by X-ray on day 60. In two patients expulsion was confirmed by X-ray on day 90. Upper endoscopy and gastrographin swallow were performed in all patients (n = 27) at 30 day FU and gastrographin swallow were performed in all patients (n = 27) at 90 day FU and anastomoses were patent in all patients (27/27, 100%). Figure 1 and Fig. 2 show the endoscopic and radiological documentation of the duodeno-ileostomy. In n = 3 patients the endoscope was not able to pass through. Mean weight (in kg), BMI (in kg/m 2 ), %EWL and %TWL and HbA1c (in %) at 30 days (n = 27) and 60 days (n = 25) and 90 days (n = 23), 180 days (n = 17) and 270 (n = 5) are listed in Table 2 . Table 2 Follow-Up characteristics Characteristic Baseline D30 D60 D90 D180 D270 D360 Treated Patients who made each visit n = 27 n = 27 n = 25 n = 23 n = 17 n = 5 n = 0 Weight (kg) -- Mean (SEM) 101.8 (3.3) 95.0 (2.9) 92.7 (2.9) 91.3 (3.0) 87.1 (3.4) 92.8 (6.4) -- N count 27 27 25 23 16 4 0 BMI (kg/m²) -- Mean (SEM) 36.8 (0.8) 34.4 (0.8) 33.7 (0.8) 32.7 (0.8) 32.1 (1.1) 32.2 (1.4) -- N count 27 27 25 23 16 4 0 % TWL -- Mean (SEM) 6.5 (0.7) 8.5 (1.0) 10.4 (1.1) 10.7 (1.7) 13.2 (4.2) -- N count 0 27 25 23 16 4 0 % EWL -- Mean (SEM) 22.6 (2.7) 29.0 (3.7) 36.6 (4.6) 38.9 (6.6) 39.5 (11.9) -- N count 0 27 25 23 16 4 0 Glucose (mg/dL) -- Mean (SEM) 105.9 (8.1) 92.7 (3.4) 93.3 (4.8) 92.3 (4.1) 90.4 (2.8) 95.6 (10.7) -- N count 27 25 25 23 16 5 0 HbA1c (%) -- Mean (SEM) 6.0 (0.2) 5.7 (0.2) 5.4 (0.1) 5.5 (0.1) 5.5 (0.1) 5.2 (0.1) -- N count 27 25 25 23 15 5 0 The two patients who had T2DM and class I obesity, both took oral Metformin prior to surgery. One of the patient suspended, the other one is still taking the antidiabetic drug. Discussion The present Italian multicenter clinical investigation was designed to evaluate the feasibility, safety, and efficacy of side-to-side compression anastomosis using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI™ System), to achieve duodeno-ileal diversion in patients with obesity. The primary objective of this study was to assess the feasibility and performance of creating a side-to-side duodeno-ileal diversion using the MagDI System. Feasibility was defined as successful placement of the magnets (≥ 90% alignment), spontaneous passage of the magnets without surgical re-intervention, and creation of a patent anastomosis confirmed radiologically at Day 90. The primary endpoint was met since 96% of enrolled and treated participants showed a patent anastomosis at 90 day FU (27/27, 100%). Operation time was in mean 73 minutes with a mean hospital stay of 1.6 days in the first 28 cases performed in Italy. Compared to the analysis of the MBSAQIP database, these are favourable outcomes of RBS. Aceved et al. analyzed revisional bariatric cases in 26.404 patients and showed an operation length of 146.6 minutes in all cases (119.5 laparoscopic and 173.7 robotic) and a length of stay of 2.1 days (1.9 laparoscopic and 2.3 robotic) ( 10 ). This underlines that the magnetic system simplifies creation of the anastomosis and that there is still a potential for a shorter operative time once the learning curve is overcome. Nevertheless, the one case of magnet timing/failed placement highlights the importance of procedural logistics, which is necessary in every surgical unit, who wants to perform magnetic compression anastomosis. The secondary objective was to evaluate the safety of the MagDI System. Safety was assessed by the incidence of serious adverse events related to the device or procedure requiring emergency surgery or re-intervention, including all-cause mortality, intestinal perforation or peritonitis, intestinal obstruction, life-threatening bleeding, and device malfunction. The single possible device-related adverse event (abdominal pain) might be related to device passage. Nevertheless, device passage was asymptomatic in most cases and easily confirmed radiologically. In no case endoscopic removal of the magnets was necessary. Only one re-intervention was performed due to biliary peritonitis in ielal perforation during the first 30 days, demonstrating a perioperative morbidity of 4% (1/27) and a 0% mortality. The other two re-interventions during FU, due to trocar hernia and liver insufficiency, are complications described after MBS. Incisional hernia is a frequent complication of abdominal wall incision and next to the updated guidelines in laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus ( 11 ). Liver Decompensation after MBS is a rare, but a described phenomenon in the current literature ( 12 ). Since little is known about the risk factors for developing acute liver injury or failure after MBS ( 11 ) and since metabolic dysfunction-associated steatotic liver disease (MASLD) is a well known obesity-associated disease, a hepatic evaluation in patients with obesity should be discussed prior to MBS and revisional MBS. Nutritional deficiencies represent a well-recognized risk after malabsorptive bariatric procedures. In the present study, only isolated cases of vitamin and micronutrient deficiencies (Vitamin D, B12, A, K, and iron) were observed during follow-up, all of which were corrected with oral supplementation. This profile appears favorable when compared with more malabsorptive techniques such as biliopancreatic diversion with duodenal switch (BPD-DS), single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) and OAGB where severe protein-calorie malnutrition and fat-soluble vitamin deficiencies remain a major concern, necessitating lifelong supplementation and close monitoring and can require parenteral support or surgical revision ( 13 ). By contrast, the side-to-side magnetic duodeno-ileal diversion preserves part of the normal intestinal continuity and may attenuate the risk of profound malabsorption, although long-term nutritional surveillance remains mandatory to ensure safety ( 14 ). Exploratory efficacy endpoints were assessed at Days 90 and 180 and included changes from baseline in weight, BMI, %EWL, %TWL and glycemic control. Weight loss after RBS is reported to be less than after primary MBS. Chierici et al. analyzed in a systemativ review and meta-analysis weight loss after RBS in different surgical procedures. Biliopancreatic diversion with duodenal switch guaranteed the best results in terms of weight loss (1 and 3-years %TWL MD: 12.38 and 28.42) followed by single-anastomosis duodenoileal bypass (9.24 and 19.13), one anastomosis gastric bypass (7.16 and 13.1), and Roux-en-Y gastric bypass (4.68 and 7.3) compared to re-sleeve gastrectomy ( 15 ). Therefor, demonstrating an EWL% of 36.6 and a TWL% of 10.4% at 90 day FU, the side-to-side compression duodeno-ieleal anastomosis is consistent with expected results from bypass procedures, but with potentially reduced invasinveness. The metabolic effect of duodenal exclusion is well known ( 16 ) and bipartition in this study shows a HbA1c reduction of 0.5% at 90 day FU. Nevertheless the durability beyond a longer period is untested and sample size is small. This study has several limitations. First, the inclusion of two patients with T2DM and class I obesity algonside 26 patients in weight regain after SG might dilute the outcomes. Second, while preliminary weight loss efficacy is promising, the interpretation of later follow-up results is limited by the decreasing number of patients, further supporting the need for larger studies with longer-term follow-up. Third, the durability of HbA1c reduction should be beyond 12 months to highlight the metabolic effect of the procedure. Long-term surveillance for anastomotic durability and metabolic outcome is essential. Conclusion This first Italian multicenter experience demonstrates that the use of the MagDIä System for the creation of a side-to-side magnetic duodeno-ileal diversion is technically feasible, safe, and effective in the short term. The primary endpoint of feasibility was achieved in nearly all patients, with successful creation and patency of the anastomosis and spontaneous device expulsion. Safety outcomes were acceptable, with low perioperative morbidity and no mortality, although vigilance for nutritional deficiencies remains essential. Preliminary efficacy results show meaningful weight reduction and early metabolic improvements, including a decrease in HbA1c, confirming the potential role of this technique in patients with weight regain after SG and in selected patients with T2DM and class I obesity. Nevertheless, results should be interpreted with caution given the limited sample size, short follow-up, and heterogeneity of the study cohort. Future studies with larger patient populations, longer follow-up, and direct comparison with established revisional bariatric procedures are required to fully clarify the role of magnetic compression duodeno-ileal diversion both as a revisional and potentially as a primary bariatric intervention. Finally, magnetic compression might represent a paradigm shift in the future. Abbreviations MBS Metabolic and Bariatric Surgery RBS Revisional bariatric surgery SG Sleeve Gastrectomy FU follow up RYGB Roux-en Y Gastric Bypass OAGB One anastomosis Gastric Bypass SADI-S Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy PI Principal Investigator T2DM Type 2 Diabetes Mellitus POD postoperative day MASLD metabolic dysfunction-associated steatotic liver disease TWL% Total Body Weight Loss in % EWL% Excess Body Weight Loss in % BMI Body Mass Index Declarations Ethical Approval Statement: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed Consent Statement: Informed consent was obtained from all individual participants included in the study. Funding: The study protocol was disegned and the whole study was funded by GT Metabolicä Acknowledgment: The authors want to thank the whole teams of Ospedale Evangelico Betania, Naples; Maria Cecilia Hospital, Cotignola (Ravenna); Policlinico San Marco, Zingonia (Bergamo) and San Raffaele Scientific Institute, Milan for the great collaboration and support. Especially the endoscopy departments and the endoscopists Massimiliano De Seta, Chiara Verga, Francesco Azzolini and Domenico Benavoli. References Gagner M, Almutlaq L, Cadiere GB, Torres AJ, Sanchez-Pernaute A, Buchwald JN, et al. Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy. Surg Obes Relat Dis. 2024;20(4):341-52. Gagner M, Abuladze D, Buchwald J, Koiava L, Almutlaq L. 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Surg Endosc. 2020;34(4):1573-84. Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, et al. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022;109(12):1239-50. Vande Berg P, Ulaj A, de Broqueville G, de Vos M, Delire B, Hainaut P, et al. Liver Decompensation after Bariatric Surgery in the Absence of Cirrhosis. Obes Surg. 2022;32(4):1227-35. Abedalqader T, Jawhar N, Gajjar A, Portela R, Perrotta G, El Ghazal N, et al. Hypoabsorption in Bariatric Surgery: Is the Benefit Worth the Risk? Medicina (Kaunas). 2025;61(3). Mechanick JI, Apovian C, Brethauer S, Garvey WT, Joffe AM, Kim J, et al. Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures - 2019 Update: Cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, the Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists - Executive Summary. Endocr Pract. 2019;25(12):1346-59. A C, N C, A I. Postoperative morbidity and weight loss after revisional bariatric surgery for primary failed restrictive procedure: A systematic review and network meta-analysis. Int J Surg. 2022;102:106677. Habegger KM, Al-Massadi O, Heppner KM, Myronovych A, Holland J, Berger J, et al. Duodenal nutrient exclusion improves metabolic syndrome and stimulates villus hyperplasia. Gut. 2014;63(8):1238-46. Additional Declarations Competing interest reported. Conflict of Interest Statement: Dr. Sonja Chiappetta, Prof. Paolo Gentileschi, Prof. Stefano Olmi and Dr. Marco Anselmino received a study grant as Principal Investigators of the study “Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Italy to Achieve Duodeno-Ileal Diversion in Adults with Obesity and with or without Type 2 Diabetes Mellitus: MagDI Italy Study. Dr. Giovanni Cesana has no conflict of interest or financial tie to disclose. Prof. Michel Gagner owns part of GT Metabolic and has a stock ownership (minority) of GT Metabolic, and played role as consultant receiving consulting fees for his proctoring during the study to cover travel expenses and proctor activity. Cite Share Download PDF Status: Published Journal Publication published 25 Nov, 2025 Read the published version in Obesity Surgery → Version 1 posted Editorial decision: Revision requested 05 Nov, 2025 Reviews received at journal 26 Oct, 2025 Reviewers agreed at journal 12 Oct, 2025 Reviewers agreed at journal 07 Oct, 2025 Reviewers invited by journal 07 Oct, 2025 Editor assigned by journal 19 Sep, 2025 Submission checks completed at journal 18 Sep, 2025 First submitted to journal 02 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7519191","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":531156265,"identity":"f55da92f-8ef4-4591-8e4a-386a1f14cad9","order_by":0,"name":"Sonja 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1","display":"","copyAsset":false,"role":"figure","size":19709,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eEndoscopic control with patent duodeno-ielostomy on POD 30\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-7519191/v1/d9dc7c35db92e2fae58bdb98.png"},{"id":93913606,"identity":"1c098973-9de0-432d-892e-06299c97b067","added_by":"auto","created_at":"2025-10-20 08:37:44","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":7332,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eRadiologic control with patent duodeno-ileostomy on POD 30\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-7519191/v1/62b37967307ca40507002d96.png"},{"id":93913614,"identity":"9cce7ded-3c83-483d-b771-6acb44997f15","added_by":"auto","created_at":"2025-10-20 08:37:44","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":914386,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eLaparoscopic duodeno-ielostomy during revisional surgery for hernia repair on POD 203\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-7519191/v1/52b0d29f14cf32aeb7aee8ee.png"},{"id":97179572,"identity":"7c0da899-d250-4aed-a3e1-8dbd1c58f678","added_by":"auto","created_at":"2025-12-01 16:16:13","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1869394,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7519191/v1/078d4b4d-996a-4ffb-bb16-b114695b03bd.pdf"}],"financialInterests":"Competing interest reported. Conflict of Interest Statement:\nDr. Sonja Chiappetta, Prof. Paolo Gentileschi, Prof. Stefano Olmi and Dr. Marco Anselmino received a study grant as Principal Investigators of the study “Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Italy to Achieve Duodeno-Ileal Diversion in Adults with Obesity and with or without Type 2 Diabetes Mellitus: MagDI Italy Study. \nDr. Giovanni Cesana has no conflict of interest or financial tie to disclose.\nProf. Michel Gagner owns part of GT Metabolic and has a stock ownership (minority) of GT Metabolic, and played role as consultant receiving consulting fees for his proctoring during the study to cover travel expenses and proctor activity.","formattedTitle":"Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) to Achieve Duodeno-Ileal Diversion in patients with Obesity: Preliminary Italian multi-center results","fulltext":[{"header":"Key Points","content":"\u003cp\u003e\u0026bull; Side-to-side magnet compression duodeno-ileal anastomosis bipartition in weight regain after Sleeve Gastrectomy was feasible.\u003c/p\u003e\u003cp\u003e\u0026bull; Side-to-side magnet compression duodeno-ileal anastomosis bipartition in weight regain after Sleeve Gastrectomy was safe.\u003c/p\u003e\u003cp\u003e\u0026bull; Future Follow-Up data and future studies are necessary to understand the role of magnetic side-to-side duodeno-ileal diversion in the future.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eLinear magnetic compression represents an emerging technique for the creation of gastrointestinal anastomoses (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) and may, in the future, serve as an alternative to conventional sutures and metallic staples. The new concept in creating anastomoses might address surgical challenges and further reduce the risk of perioperative morbidity, mainly due to bleeding or leakage.\u003c/p\u003e\u003cp\u003eDue to the chronic and relapsing nature of obesity, both insufficient initial response and late post-operative clinical deterioration are well-documented phenomena following metabolic and bariatric surgery (MBS). These may present as inadequate weight loss, weight regain, or recurrence and progression of obesity-related comorbidities after an initially satisfactory outcome. A multimodal approach in these patients is necessary and revisional bariatric surgery (RBS) utilizing minimally invasive surgery and transoral endoscopic techniques is a recognized therapeutic strategy (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). On the other hand it is well known, that RBS increase the risk for perioperative complications and risk stratification is of most importance in these patients (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eSleeve Gastrectomy (SG) is the most performed MBS worldwide and therefor a high number of patients may need RBS in case of inadequate weight loss, weight regain, or recurrence and progression of obesity-related comorbidities. Guan et al. reported a revision rate of 22.6% in patients after SG with a\u0026thinsp;\u0026ge;\u0026thinsp;10-year follow-up (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Bypass procedures such as Roux-en Y Gastric Bypass (RYGB), One anastomosis Gastric Bypass (OAGB) and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S) are well known revisional procedures after SG (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e.\u003c/p\u003e\u003cp\u003eSG with transit bipartition (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) and Transit Bipartition after SG (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) are discussed in the current literature, due to several potential advantages: reduced surgical invasiveness, the metabolic effect of duodenal exclusion, and preservation of normal anatomy, thereby maintaining the feasibility of subsequent endoscopic procedures such as ERCP in patients with gallstone disease. Moreover, the persistence of intestinal bipartition may attenuate the risk of severe malnutrition.\u003c/p\u003e\u003cp\u003eMagnetic side-to-side compression duodeno-ileal diversion anastomosis may offer a surgical stepforward and a less invasive surgical procedure.\u003c/p\u003e\u003cp\u003eThe present Italian multicenter clinical investigation was designed to evaluate the feasibility, safety, and efficacy of side-to-side compression anastomosis using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI\u0026trade; System), to achieve duodeno-ileal diversion in patients with obesity.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis was a prospective, single-arm, multicenter clinical investigation (MagDI Italy Study, GTM-010 Rev.B; 03Apr2024 and Rev.2; 12Nov2024; Eudamed Number CIV-IT-23-11-044644) designed to evaluate the feasibility, safety, and preliminary efficacy of the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDIä\u0026nbsp;System) for the creation of a side-to-side duodeno-ileal diversion anastomosis. The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and approved by the ethics committee and Italian Ministry of Health under authorization number 0059320-12/07/2024-DGDMF-MDS-P.\u003c/p\u003e\n\u003cp\u003eThe study was conducted in four Italian clinical centers: Ospedale Evangelico Betania, Naples\u003csup\u003e1\u003c/sup\u003e (Principal Investigator (PI) Sonja Chiappetta; n = 10); Maria Cecilia Hospital, Cotignola (Ravenna)\u003csup\u003e2\u003c/sup\u003e (PI Paolo Gentileschi; n = 9); Policlinico San Marco, Zingonia (Bergamo)\u003csup\u003e3\u003c/sup\u003e (PIs Stefano Olmi and Giovanni Cesena; n=5); and San Raffaele Scientific Institute, Milan\u003csup\u003e4\u003c/sup\u003e (PI Marco Anselmino; n=4). Michel Gagner from Westmount Square Surgical Center – Westmount, Quebec, Canada\u003csup\u003e5\u003c/sup\u003e played the role of trainer and proctor during most of the procedures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdults (18-65 years) with obesity (BMI between 30-50 kg/m²) who had one of the following criteria were eligible:\u003c/p\u003e\n\u003cp\u003ea.\u0026nbsp;Type 2 Diabetes Mellitus (T2DM; defined as HbA1c\u0026nbsp;≥\u0026nbsp;6.5%) or weight regain following previous SG (≥\u0026nbsp;12 months);\u0026nbsp;OR\u003c/p\u003e\n\u003cp\u003eb.\u0026nbsp;T2DM (defined as HbA1c\u0026nbsp;≥\u0026nbsp;6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥\u0026nbsp;12 months);\u0026nbsp;OR\u003c/p\u003e\n\u003cp\u003ec.\u0026nbsp;T2DM (defined as HbA1c\u0026nbsp;≥\u0026nbsp;6.5%) with a Body Mass Index between 30-35 and without previous SG and no plan to perform a concurrent SG.\u003c/p\u003e\n\u003cp\u003eAll participants agreed to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study and all participants have been informed of the nature of the study and agreed to its provisions, complying with study required testing, medications, follow-up visits for 12 months and had provided written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients were excluded if they had type 1 diabetes, required injectable insulin, or had uncontrolled T2DM. Additional exclusions included uncontrolled hypertension, dyslipidemia, or sleep apnea; previous intestinal, colonic, or duodenal surgery (other than bariatric); or conditions such as scarring, abnormal anatomy, or prior interventions that would preclude the procedure. Patients with refractory gastroesophageal reflux disease, Barrett’s esophagus, Helicobacter pylori infection, active ulcer disease, large hiatal hernia, inflammatory bowel disease, or diverticulitis were not eligible. Technical exclusions included any anomaly preventing orogastric, endoscopic, or laparoscopic access, the presence of implantable pacemakers/defibrillators, or anticipated need for MRI within two months post-procedure. Psychiatric disorders (other than well-controlled depression), history of substance abuse, pregnancy or planned pregnancy, recent tobacco/nicotine cessation (\u0026lt; 3 months), active infection, chronic anticoagulation (except aspirin), or known allergies to device components or contrast media also led to exclusion. Further criteria included unhealed ulcers, bleeding or neoplastic lesions at the magnet deployment site, life expectancy ≤12 months, stroke or transient ischemic attack within 6 months, or participation in another investigational study not yet at its primary endpoint. Finally, patients with COVID-19 positivity before the procedure or any other medical, anatomical, social, or psychological condition deemed unsafe or likely to interfere with follow-up were excluded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePreoperative Evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBaseline assessments included detailed medical history with prior and current medications, physical examination, vital signs, anthropometric measurements (weight, height, waist circumference, BMI), medical and obesity history, psychological evaluation, laboratory blood tests, and pregnancy testing when applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSurgical Procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProcedures were performed under general anesthesia using a standard laparoscopic approach within 45 days of enrollment. During all the surgical procedures Michel Gagner was present in the Operating Room.\u003c/p\u003e\n\u003cp\u003ePatients underwent a side-to-side duodeno-ileal diversion using a biofragmentable magnetic device, composed of paired magnets (GT Metabolicä\u0026nbsp;DI Magnet; linear, 39mm). The first magnet was swallowed by the patient prior to surgery. It was then placed laparoscopically 250 cm proximal the ileocecal valve and the second magnet was delivered endoscopically to the duodenum to get aligned the two magnets and to create a magnet compression duodeno-ileal anastomosis. The mesenteric space was closed at the end of the procedure. Standard perioperative monitoring was performed.\u003c/p\u003e\n\u003cp\u003eThe strong magnetic attraction compressed the adjacent bowel walls (duodeno-ileostomy), inducing ischemia and tissue remodeling, which over several days resulted in the formation of a side-to-side duodeno-ileostomy. After maturation of the anastomosis, the device separated and was naturally expelled per rectum.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePostoperative Management and Follow-Up\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients were monitored clinically, hemodynamically, and electrocardiographically for approximately 24 hours. On postoperative day (POD) 1, radiographic imaging was used to confirm device position and early anastomosis formation. Before discharge, patients received standardized dietary counseling with staged progression from liquids to solids under nutritional supervision.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eScheduled follow-up visits occurred at Days 14, 30, 60, 90, 180, 270, and 360.\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAssessments included physical examination, vital signs, anthropometric measurements, laboratory tests (metabolic and nutritional parameters), and imaging until anastomosis patency and device passage were confirmed. Upper endoscopy was initially planned after magnetic expulsion at day 30, 60 or 90 and at day 180 and 360. The timepoints of upper endoscopy were revised to better align with standard of care practice at study sites to day 90 and 360 (Rev.2; 12Nov2024). All adverse events were recorded and graded according to the Clavien–Dindo classification (9). Patient-reported satisfaction questionnaires were administered at 6 and 12 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy objectives and endpoints\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary objective of this study was to assess the feasibility and performance of creating a side-to-side duodeno-ileal diversion using the MagDI System. Feasibility was defined as successful placement of the magnets (≥90% alignment), spontaneous passage of the magnets without surgical re-intervention, and creation of a patent anastomosis confirmed radiologically at Day 90. The primary endpoint was met if feasibility was achieved in at least 80% of enrolled and treated participants.\u003c/p\u003e\n\u003cp\u003eThe secondary objective was to evaluate the safety of the MagDI System. Safety was assessed by the incidence of serious adverse events related to the device or procedure requiring emergency surgery or re-intervention, including all-cause mortality, intestinal perforation or peritonitis, intestinal obstruction, life-threatening bleeding, and device malfunction.\u003c/p\u003e\n\u003cp\u003eExploratory efficacy endpoints were assessed at Days 90, 180, and 360, and included changes from baseline in weight, body mass index (BMI), percent excess weight loss (%EWL), total body weight loss (%TWL), glycemic control (HbA1c, fasting glucose), and use of antidiabetic medications. These endpoints were chosen as clinically relevant and validated measures of weight reduction, metabolic improvement, and overall therapeutic effect.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis was a feasibility study with a planned sample size of up to 50 participants. No formal hypothesis testing was conducted. Data were analyzed descriptively: continuous variables are presented as means ± standard deviation or medians with interquartile ranges, and categorical variables as frequencies and percentages.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eBetween September 20, 2024 and February 2nd, 2025, 28 patients (19F, 9M) underwent surgery. Mean age was 44 years, mean weight was 101.3\u0026thinsp;\u0026plusmn;\u0026thinsp;16.8 kg (Min 73kg, Max 139) and mean BMI was 36.7\u0026thinsp;\u0026plusmn;\u0026thinsp;4.4 kg/m\u003csup\u003e2\u003c/sup\u003e (Min 30 kg/m\u003csup\u003e2\u003c/sup\u003e, Max 45.5 kg/m\u003csup\u003e2\u003c/sup\u003e). Surgery after SG was performed in 26 patients. Two patients had T2DM and class I obesity. Surgery was performed 6.3 years after SG in 15 patients.\u003c/p\u003e\u003cp\u003eAll patients swallowed the magnet without problems prior to surgery and magnetic anastomosis was achieved in 27/28 (96%) patients. Mean operative time was 73.2 +/- 27.5 minutes (min 45, max 145). Mean hospital stay was 1.6 days (range 1\u0026ndash;3).\u003c/p\u003e\u003cp\u003eIn two patients, unplanned concomitant procedures were performed according to clinical needs: cholecystectomy and hiatoplasty in one, and adhesiolisis and umbilical hernia repair with intraperitoneal onlay mash in ombelical hernia in the other.\u003c/p\u003e\u003cp\u003ePerioperative 30-day morbidity was 4% (1/27) and mortality was 0%. There was one possibly device-related readmission due to abdominal pain/cramps from POD 22\u0026ndash;29 in one patient (Clavien-Dindo II).\u003c/p\u003e\u003cp\u003eIn one patient, creation of the magnetic anastomosis was not performed. Due to organizational reasons, surgery was initiated 8.5 hours after magnet ingestion, at which point the magnet was already located in the cecum. It was not possible to reposition it into the ileum because of the ileocecal valve and surgery was interrupted.\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows the different complications. There were seven procedure-related serious adverse events: In four patients intestinal serosal tears were repaired by stitches during the procedure, without sequelae. One patient presented a superficial pharyngeal lesion during endoscopic magnet placement, which healed without treatment. In one patient enterotomy was performed and sutured without consequences. One patient had a perforation in the biliopancreatic limb and was reoperated due to biliary peritonitis at POD 2.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eComplications:\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDescription\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSponsor Relationship to Device\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSponsor Relationship to Procedure\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSerious Adverse Event (SAE)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eClavien-Dindo Classification\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSerosal tears (n\u0026thinsp;=\u0026thinsp;4) during surgery\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade III\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNutritional \u0026ndash; ipovitaminosis D\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade II\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePharyngeal lesion\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade II\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLiver insufficiency leading to DI reversal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade III\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNutrition - Vitamin/Mineral deficiency (B12, A, K, and Iron)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eProbably Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade I\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSeroma post IPOM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIndeterminate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade II\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHernia - umbilical, trocar site\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade III\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEnterotomy - Magnet placement\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade III\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGI - Abd cramps, Pain - Abd\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePossibly Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade II\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePerforation - intestinal during procedure\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDefinitely Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade III\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCholedocholithiasis with sepsis - Biliary tract clearance and cholecystectomy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNot Related\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eGrade III\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003cb\u003eClavien-Dindo Classification of surgical complications\u003c/b\u003e: \u003cb\u003eGrade I\u003c/b\u003e: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Antiemetics, antipyretics, analgesics, diuretics and electro- lytes, and physiotherapy allowed. \u003cb\u003eGrade II\u003c/b\u003e: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition included. \u003cb\u003eGrade III\u003c/b\u003e: Requiring surgical, endoscopic, or radiological intervention. \u003cb\u003eGrade IV\u003c/b\u003e: Life-threatening complication (including certain central nervous system complications) requiring Intermediate Care/Intensive Care Unit-management. \u003cb\u003eGrade V\u003c/b\u003e: Death of patient (PMID: )\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThere were further procedure-related serious adverse events during FU until 21.08.2025.\u003c/p\u003e\u003cp\u003eOne hypovitaminosis D on POD 33 and one hypovitaminosis of iron, B12, Vitamin A and K on POD 181. Both solved with oral vitamin substitution.\u003c/p\u003e\u003cp\u003eThree patients were reoperated: one patient due to sepsis from acute cholecystitis in gallbladder stones (ERCP and laparoscopic cholecystectomy on POD 90), one laparoscopic reconversion to normal anatomy due to liver insufficiency (Child Pugh C) in severe malnutrition on POD 144 and one surgical trocar site hernia repair on POD 203. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows the duodeno-ileostomy during trocar site hernia surgery on POD 203.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003ePaired magnets were expelled in all patients at a median of 37.3 days (min 15, max 97). Only 9 subjects were aware of magnet passage. In most cases (n\u0026thinsp;=\u0026thinsp;22), X-ray on day 30 confirmed expulsion. In three patients expulsion was confirmed by X-ray on day 60. In two patients expulsion was confirmed by X-ray on day 90.\u003c/p\u003e\u003cp\u003eUpper endoscopy and gastrographin swallow were performed in all patients (n\u0026thinsp;=\u0026thinsp;27) at 30 day FU and gastrographin swallow were performed in all patients (n\u0026thinsp;=\u0026thinsp;27) at 90 day FU and anastomoses were patent in all patients (27/27, 100%). Figure\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e1\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e2\u003c/span\u003e show the endoscopic and radiological documentation of the duodeno-ileostomy. In n\u0026thinsp;=\u0026thinsp;3 patients the endoscope was not able to pass through.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eMean weight (in kg), BMI (in kg/m\u003csup\u003e2\u003c/sup\u003e), %EWL and %TWL and HbA1c (in %) at 30 days (n\u0026thinsp;=\u0026thinsp;27) and 60 days (n\u0026thinsp;=\u0026thinsp;25) and 90 days (n\u0026thinsp;=\u0026thinsp;23), 180 days (n\u0026thinsp;=\u0026thinsp;17) and 270 (n\u0026thinsp;=\u0026thinsp;5) are listed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eFollow-Up characteristics\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"8\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristic\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBaseline\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eD30\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eD60\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eD90\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eD180\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eD270\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003eD360\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTreated Patients who made each visit\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003en\u0026thinsp;=\u0026thinsp;0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWeight (kg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- Mean (SEM)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e101.8 (3.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e95.0 (2.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e92.7 (2.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e91.3 (3.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e87.1 (3.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e92.8 (6.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- N count\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI (kg/m\u0026sup2;)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- Mean (SEM)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e36.8 (0.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e34.4 (0.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e33.7 (0.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e32.7 (0.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e32.1 (1.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e32.2 (1.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- N count\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e% TWL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- Mean (SEM)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6.5 (0.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e8.5 (1.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e10.4 (1.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e10.7 (1.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e13.2 (4.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- N count\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e% EWL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- Mean (SEM)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22.6 (2.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e29.0 (3.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e36.6 (4.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e38.9 (6.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e39.5 (11.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- N count\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGlucose (mg/dL)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- Mean (SEM)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e105.9 (8.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e92.7 (3.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e93.3 (4.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e92.3 (4.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e90.4 (2.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e95.6 (10.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- N count\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHbA1c (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- Mean (SEM)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6.0 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5.7 (0.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5.4 (0.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5.5 (0.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e5.5 (0.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e5.2 (0.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-- N count\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe two patients who had T2DM and class I obesity, both took oral Metformin prior to surgery. One of the patient suspended, the other one is still taking the antidiabetic drug.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe present Italian multicenter clinical investigation was designed to evaluate the feasibility, safety, and efficacy of side-to-side compression anastomosis using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI\u0026trade; System), to achieve duodeno-ileal diversion in patients with obesity.\u003c/p\u003e\u003cp\u003eThe primary objective of this study was to assess the feasibility and performance of creating a side-to-side duodeno-ileal diversion using the MagDI System. Feasibility was defined as successful placement of the magnets (\u0026ge;\u0026thinsp;90% alignment), spontaneous passage of the magnets without surgical re-intervention, and creation of a patent anastomosis confirmed radiologically at Day 90. The primary endpoint was met since 96% of enrolled and treated participants showed a patent anastomosis at 90 day FU (27/27, 100%). Operation time was in mean 73 minutes with a mean hospital stay of 1.6 days in the first 28 cases performed in Italy. Compared to the analysis of the MBSAQIP database, these are favourable outcomes of RBS. Aceved et al. analyzed revisional bariatric cases in 26.404 patients and showed an operation length of 146.6 minutes in all cases (119.5 laparoscopic and 173.7 robotic) and a length of stay of 2.1 days (1.9 laparoscopic and 2.3 robotic) (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). This underlines that the magnetic system simplifies creation of the anastomosis and that there is still a potential for a shorter operative time once the learning curve is overcome. Nevertheless, the one case of magnet timing/failed placement highlights the importance of procedural logistics, which is necessary in every surgical unit, who wants to perform magnetic compression anastomosis.\u003c/p\u003e\u003cp\u003eThe secondary objective was to evaluate the safety of the MagDI System. Safety was assessed by the incidence of serious adverse events related to the device or procedure requiring emergency surgery or re-intervention, including all-cause mortality, intestinal perforation or peritonitis, intestinal obstruction, life-threatening bleeding, and device malfunction.\u003c/p\u003e\u003cp\u003eThe single possible device-related adverse event (abdominal pain) might be related to device passage. Nevertheless, device passage was asymptomatic in most cases and easily confirmed radiologically. In no case endoscopic removal of the magnets was necessary.\u003c/p\u003e\u003cp\u003eOnly one re-intervention was performed due to biliary peritonitis in ielal perforation during the first 30 days, demonstrating a perioperative morbidity of 4% (1/27) and a 0% mortality. The other two re-interventions during FU, due to trocar hernia and liver insufficiency, are complications described after MBS. Incisional hernia is a frequent complication of abdominal wall incision and next to the updated guidelines in laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Liver Decompensation after MBS is a rare, but a described phenomenon in the current literature (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Since little is known about the risk factors for developing acute liver injury or failure after MBS (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) and since metabolic dysfunction-associated steatotic liver disease (MASLD) is a well known obesity-associated disease, a hepatic evaluation in patients with obesity should be discussed prior to MBS and revisional MBS.\u003c/p\u003e\u003cp\u003eNutritional deficiencies represent a well-recognized risk after malabsorptive bariatric procedures. In the present study, only isolated cases of vitamin and micronutrient deficiencies (Vitamin D, B12, A, K, and iron) were observed during follow-up, all of which were corrected with oral supplementation. This profile appears favorable when compared with more malabsorptive techniques such as biliopancreatic diversion with duodenal switch (BPD-DS), single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) and OAGB where severe protein-calorie malnutrition and fat-soluble vitamin deficiencies remain a major concern, necessitating lifelong supplementation and close monitoring and can require parenteral support or surgical revision (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). By contrast, the side-to-side magnetic duodeno-ileal diversion preserves part of the normal intestinal continuity and may attenuate the risk of profound malabsorption, although long-term nutritional surveillance remains mandatory to ensure safety (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eExploratory efficacy endpoints were assessed at Days 90 and 180 and included changes from baseline in weight, BMI, %EWL, %TWL and glycemic control.\u003c/p\u003e\u003cp\u003eWeight loss after RBS is reported to be less than after primary MBS. Chierici et al. analyzed in a systemativ review and meta-analysis weight loss after RBS in different surgical procedures. Biliopancreatic diversion with duodenal switch guaranteed the best results in terms of weight loss (1 and 3-years %TWL MD: 12.38 and 28.42) followed by single-anastomosis duodenoileal bypass (9.24 and 19.13), one anastomosis gastric bypass (7.16 and 13.1), and Roux-en-Y gastric bypass (4.68 and 7.3) compared to re-sleeve gastrectomy (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Therefor, demonstrating an EWL% of 36.6 and a TWL% of 10.4% at 90 day FU, the side-to-side compression duodeno-ieleal anastomosis is consistent with expected results from bypass procedures, but with potentially reduced invasinveness.\u003c/p\u003e\u003cp\u003eThe metabolic effect of duodenal exclusion is well known (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) and bipartition in this study shows a HbA1c reduction of 0.5% at 90 day FU. Nevertheless the durability beyond a longer period is untested and sample size is small.\u003c/p\u003e\u003cp\u003eThis study has several limitations. First, the inclusion of two patients with T2DM and class I obesity algonside 26 patients in weight regain after SG might dilute the outcomes. Second, while preliminary weight loss efficacy is promising, the interpretation of later follow-up results is limited by the decreasing number of patients, further supporting the need for larger studies with longer-term follow-up. Third, the durability of HbA1c reduction should be beyond 12 months to highlight the metabolic effect of the procedure. Long-term surveillance for anastomotic durability and metabolic outcome is essential.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis first Italian multicenter experience demonstrates that the use of the MagDI\u0026auml;\u0026nbsp;System for the creation of a side-to-side magnetic duodeno-ileal diversion is technically feasible, safe, and effective in the short term. The primary endpoint of feasibility was achieved in nearly all patients, with successful creation and patency of the anastomosis and spontaneous device expulsion. Safety outcomes were acceptable, with low perioperative morbidity and no mortality, although vigilance for nutritional deficiencies remains essential. Preliminary efficacy results show meaningful weight reduction and early metabolic improvements, including a decrease in HbA1c, confirming the potential role of this technique in patients with weight regain after SG and in selected patients with T2DM and class I obesity.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNevertheless, results should be interpreted with caution given the limited sample size, short follow-up, and heterogeneity of the study cohort. Future studies with larger patient populations, longer follow-up, and direct comparison with established revisional bariatric procedures are required to fully clarify the role of magnetic compression duodeno-ileal diversion both as a revisional and potentially as a primary bariatric intervention. Finally, magnetic compression might represent a paradigm shift in the future.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eMBS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMetabolic and Bariatric Surgery\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRBS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eRevisional bariatric surgery\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSG\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSleeve Gastrectomy\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eFU\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003efollow up\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRYGB\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eRoux-en Y Gastric Bypass\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eOAGB\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eOne anastomosis Gastric Bypass\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSADI-S\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSingle Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePI\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePrincipal Investigator\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eT2DM\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eType 2 Diabetes Mellitus\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePOD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003epostoperative day\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eMASLD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003emetabolic dysfunction-associated steatotic liver disease\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eTWL%\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eTotal Body Weight Loss in %\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eEWL%\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eExcess Body Weight Loss in %\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eBMI\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBody Mass Index\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval Statement:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed Consent Statement:\u0026nbsp;\u003c/strong\u003eInformed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e The study protocol was disegned and the whole study was funded by GT Metabolicä\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgment:\u0026nbsp;\u003c/strong\u003eThe authors want to thank the whole teams of Ospedale Evangelico Betania, Naples; Maria Cecilia Hospital, Cotignola (Ravenna); Policlinico San Marco, Zingonia (Bergamo) and San Raffaele Scientific Institute, Milan for the great collaboration and support. Especially the endoscopy departments and the endoscopists Massimiliano De Seta, Chiara Verga, Francesco Azzolini and Domenico Benavoli.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGagner M, Almutlaq L, Cadiere GB, Torres AJ, Sanchez-Pernaute A, Buchwald JN, et al. Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy. Surg Obes Relat Dis. 2024;20(4):341-52.\u003c/li\u003e\n\u003cli\u003eGagner M, Abuladze D, Buchwald J, Koiava L, Almutlaq L. First-in-Human Side-to-Side Duodenoileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System. J Am Coll Surg. 2025;241(2):146-59.\u003c/li\u003e\n\u003cli\u003eSample JW, Jawhar N, Bocchinfuso S, Abedalqader T, Betancourt RS, Laplante S, et al. Trends in bariatric surgery revisions: a 25-year single-institution experience. Surg Endosc. 2025;39(6):3797-806.\u003c/li\u003e\n\u003cli\u003eGero D, Vannijvel M, Okkema S, Deleus E, Lloyd A, Lo Menzo E, et al. Defining Global Benchmarks in Elective Secondary Bariatric Surgery Comprising Conversional, Revisional, and Reversal Procedures. Ann Surg. 2021;274(5):821-8.\u003c/li\u003e\n\u003cli\u003eGuan B, Chong TH, Peng J, Chen Y, Wang C, Yang J. Mid-long-term Revisional Surgery After Sleeve Gastrectomy: a Systematic Review and Meta-analysis. Obes Surg. 2019;29(6):1965-75.\u003c/li\u003e\n\u003cli\u003eFranken RJ, Sluiter NR, Franken J, de Vries R, Souverein D, Gerdes VEA, et al. Treatment Options for Weight Regain or Insufficient Weight Loss After Sleeve Gastrectomy: a Systematic Review and Meta-analysis. Obes Surg. 2022;32(6):2035-46.\u003c/li\u003e\n\u003cli\u003eSantoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, et al. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012;256(1):104-10.\u003c/li\u003e\n\u003cli\u003eReiser M, Christogianni V, Nehls F, Dukovska R, de la Cruz M, Busing M. Short-term Results of Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy. Ann Surg Open. 2021;2(4):e102.\u003c/li\u003e\n\u003cli\u003eClavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187-96.\u003c/li\u003e\n\u003cli\u003eAcevedo E, Mazzei M, Zhao H, Lu X, Edwards MA. Outcomes in conventional laparoscopic versus robotic-assisted revisional bariatric surgery: a retrospective, case-controlled study of the MBSAQIP database. Surg Endosc. 2020;34(4):1573-84.\u003c/li\u003e\n\u003cli\u003eDeerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, et al. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022;109(12):1239-50.\u003c/li\u003e\n\u003cli\u003eVande Berg P, Ulaj A, de Broqueville G, de Vos M, Delire B, Hainaut P, et al. Liver Decompensation after Bariatric Surgery in the Absence of Cirrhosis. Obes Surg. 2022;32(4):1227-35.\u003c/li\u003e\n\u003cli\u003eAbedalqader T, Jawhar N, Gajjar A, Portela R, Perrotta G, El Ghazal N, et al. Hypoabsorption in Bariatric Surgery: Is the Benefit Worth the Risk? Medicina (Kaunas). 2025;61(3).\u003c/li\u003e\n\u003cli\u003eMechanick JI, Apovian C, Brethauer S, Garvey WT, Joffe AM, Kim J, et al. Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures - 2019 Update: Cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, the Obesity Society, American Society for Metabolic \u0026amp; Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists - Executive Summary. Endocr Pract. 2019;25(12):1346-59.\u003c/li\u003e\n\u003cli\u003eA C, N C, A I. Postoperative morbidity and weight loss after revisional bariatric surgery for primary failed restrictive procedure: A systematic review and network meta-analysis. Int J Surg. 2022;102:106677.\u003c/li\u003e\n\u003cli\u003eHabegger KM, Al-Massadi O, Heppner KM, Myronovych A, Holland J, Berger J, et al. Duodenal nutrient exclusion improves metabolic syndrome and stimulates villus hyperplasia. Gut. 2014;63(8):1238-46.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"obesity-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"obsu","sideBox":"Learn more about [Obesity Surgery](https://link.springer.com/journal/11695)","snPcode":"11695","submissionUrl":"https://submission.springernature.com/new-submission/11695/3","title":"Obesity Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"magnetic surgery, magnets, linear magnets, revisional bariatric surgery, weight regain after sleeve gastrectomy, bipartition","lastPublishedDoi":"10.21203/rs.3.rs-7519191/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7519191/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eLinear magnetic compression is a novel technique to perform gastrointestinal anastomosis.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eThis Italian multi-center clinical investigation aimed to evaluate the feasibility, safety and efficacy of the creation of a side-to-side compression anastomosis using the GT Metabolic Solutions\u0026trade; Magnet System, DI Biofragmentable (MagDI\u0026trade; System) to achieve duodeno-ileal diversion.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003ePatients with a body mass index (BMI) of \u0026ge;\u0026thinsp;30 to 50 kg/m\u003csup\u003e2\u003c/sup\u003e and weight regain and/or type 2 diabetes mellitus (T2DM) after sleeve gastrectomy (SG) and patients with a BMI of \u0026ge;\u0026thinsp;30 to 35 kg/m\u003csup\u003e2\u003c/sup\u003e and T2DM underwent a side-to-side duodeno-ileal diversion using the GT Metabolic\u0026trade; DI Magnet (linear, 39mm).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003e28 patients (19F) underwent surgery in 4 centers in the time between 09/24 and 02/25. Mean age and BMI were 44 years and 36.7\u0026thinsp;\u0026plusmn;\u0026thinsp;4.4 kg/m\u003csup\u003e2\u003c/sup\u003e. Mean operative time and hospital stay were 73.2 minutes and 1.6 days. Paired magnets were expelled in all patients in a mean of 37.3 days. There were three procedure-related serious adverse events (Clavien Dindo III, one ileal perforation on POD 1, one liver insufficiency leading to reversal on POD 144 and one trocar site hernia on POD 203). Mean BMI, %EWL and %TWL at 90 days (n\u0026thinsp;=\u0026thinsp;23) were 32.7\u0026thinsp;\u0026plusmn;\u0026thinsp;0.8 kg/m\u003csup\u003e2\u003c/sup\u003e, 36.6\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6% and 10.4\u0026thinsp;\u0026plusmn;\u0026thinsp;1.1%. Mean HbA1c decreased from 6% at baseline to 5.7% at 30 days and to 5.5% at 90 days.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003ePreliminary data shows that side-to-side magnet compression duodeno-ileal anastomosis was feasible, safe and effective. Future follow-up data is necessary.\u003c/p\u003e","manuscriptTitle":"Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) to Achieve Duodeno-Ileal Diversion in patients with Obesity: Preliminary Italian multi-center results","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-20 08:37:39","doi":"10.21203/rs.3.rs-7519191/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-11-05T19:29:56+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-26T16:01:22+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"290134867474828135765531791625092206112","date":"2025-10-12T15:19:03+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"79242334547336925191991081263604078498","date":"2025-10-07T11:01:01+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-07T10:27:32+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-19T16:53:27+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-18T11:35:03+00:00","index":"","fulltext":""},{"type":"submitted","content":"Obesity Surgery","date":"2025-09-02T14:57:23+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"obesity-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"obsu","sideBox":"Learn more about [Obesity Surgery](https://link.springer.com/journal/11695)","snPcode":"11695","submissionUrl":"https://submission.springernature.com/new-submission/11695/3","title":"Obesity Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"780e8a9a-d855-413d-828a-3f0fbfd99bce","owner":[],"postedDate":"October 20th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-01T16:13:15+00:00","versionOfRecord":{"articleIdentity":"rs-7519191","link":"https://doi.org/10.1007/s11695-025-08409-z","journal":{"identity":"obesity-surgery","isVorOnly":false,"title":"Obesity Surgery"},"publishedOn":"2025-11-25 15:57:49","publishedOnDateReadable":"November 25th, 2025"},"versionCreatedAt":"2025-10-20 08:37:39","video":"","vorDoi":"10.1007/s11695-025-08409-z","vorDoiUrl":"https://doi.org/10.1007/s11695-025-08409-z","workflowStages":[]},"version":"v1","identity":"rs-7519191","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7519191","identity":"rs-7519191","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}