Thirty-Day Feasibility and Safety
hematoma, intra-abdominal hematoma, pain
UNCONTROLLED HYPERTENSION, ADVERSE EVENT, EVENT, INTRA-ABDOMINAL HEMATOMA, SURGICAL COMPLICATIONS, HEMATOMA, SEQUELAE
The MS was successfully placed in all 5 patients (100.0%) and creation of a patent anastomosis was confirmed radiologically and fluoroscopically in 100.0% of procedures (Fig. Endoscopic image of a patent side-to-side duodeno-ileal anastomosis with the magnet system. View is from the pylorus toward the first part of the duodenumDuring the first 30 days, there were no device-related AEs or SAEs. Three patients had mild pain in their postoperative abdominal wounds (CDC grade I); these were treated with an intramuscular analgesic injection and resolved without sequelae. One patient had a mild mucosal tear of the upper esophagus due to endoscopic overtube insertion (CDC grade I; use of an overtube was subsequently removed from the procedure); the event resolved on the same day without sequalae. Another patient sustained an intra-abdominal hematoma adjacent to the SG staple line in the upper left quadrant diagnosed by CT scan (CDC grade II); she was observed for 24 h due to poorly controlled hypertension and required no transfusions. The hematoma was on the side opposite from the magnets and adjacent to the sleeve staple line. A final patient had a serosal tear of the ileum due to a pulling motion by laparoscopic forceps during the procedure (CDC grade III); this was immediately sutured as a precaution and resolved on the same day (Table Adverse events by number and severity post side-to-side magnet system duodeno-ileostomy with sleeve gastrectomy through day 360 by Clavien-Dindo ClassificationClavien-Dindo Classification of surgical complications [