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
Conventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs). The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anas...
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Veröffentlicht in: | Surgery for obesity and related diseases 2024-04, Vol.20 (4), p.341-352 |
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Zusammenfassung: | Conventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs).
The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anastomosis device (Magnet Anastomosis System [MS]).
Multicenter: private practices and university hospitals.
In patients with body mass index ([BMI, kg/m2] ≥35.0 to ≤50.0 with/without type 2 diabetes [T2D] glycosylated hemoglobin [HbA1C > 6.5 %]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating magnet fusion and gradual DI (MagDI). The MagDI-after-SG group had undergone prior sleeve gastrectomy (SG); the MagDI + SG group underwent concurrent SG. AEs were graded by Clavien-Dindo Classification (CDC).
Between November 22, 2021 and May 30, 2023, 43 patients (88.0% female, mean age 43.7 ± 1.3 years) underwent the study procedures. The MS met feasibility criteria of magnet device placement, creation of patent anastomoses confirmed radiologically, and magnet passage in 100.0% of patients. There were 64 AEs, most were CDC grade I and II, significantly fewer in the MagDI-after-SG group (P < .001). No device-related AEs including anastomotic leakage, bleeding, obstruction, infection, or death. The MagDI-after-SG group experienced 6-month mean weight loss of 8.0 ± 2.5 kg (P < .01), 17.4 ± 5.0% excess weight loss (EWL). The MagDI + SG group had significantly greater weight loss (34.2 ± 1.6 kg, P < .001), 66.2 ± 3.4% EWL. All patients with T2D improved.
In early results of a multicenter study, the incisionless, sutureless Magnet System formed patent, complication-free anastomoses in side-to-side DI with prior or concurrent SG.
•Magnet System created patent anastomoses in 100% of duodeno-ileostomy (DI) patients.•No Magnet System adverse events (e.g., 0% anastomotic leakage, bleeding, infection).•Six-month mean Magnet System EWL: 66.2% primary DI + SG; 17.4% revisional DI-after-SG.•The Magnet System formed complication-free anastomoses in DI-after-SG and DI + SG. |
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ISSN: | 1550-7289 1878-7533 |
DOI: | 10.1016/j.soard.2023.10.018 |