Background
Magnetic anastomosis has demonstrated the ability to reduce anastomosis complications such as leaks and bleeding. We report the procedure feasibility and 30-day results of a new novel surgical technique that eliminates the need to close the enterotomies via conventional methods (Hand-sew/Stapled) after creating the anastomosis and facilitates an immediate lumen opening between two new coupled self-forming magnets (SFM) in RYGB patients.
Methods
Prospective non-randomized single-center trial. Surgery included creating a side-to-side jejunal-jejunal anastomosis using an SFM octagonal anastomosis delivered intraluminally through a novel temporary enterotomy control and capture (ECC) device. All devices were deployed and delivered laparoscopically.
Results
A total of 09 patients were recruited, with a mean age of 48.2 (40-63) years and an initial BMI of 40.5+-6.09 kg/m2. The mean HbA1c was 12.3+-0.9. All procedures were performed laparoscopically. There was no conversion or peri-operative mortality. All ECCs and SFMs were delivered and connected with no delivery malfunctions and completed in an anastomosis creation time of 14 minutes (enterotomy to magnet coupling). All ECC and SFM passed with no retentions or patient self-reported pain. No procedure adverse events (AE) occurred during the 30-day follow-up period.
Conclusions
Preliminary and procedure feasibility data of these new surgical techniques suggest the procedures are feasible and safe in RYGB surgery. We demonstrated the potential to improve surgical outcomes and reduce surgical steps and associated operation time while standardizing the techniques for creating a reproducible anastomosis. Further and longer studies are warranted and have potential utility in other anastomosis in bariatric surgery.