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.


Background

In previously bi-partion studies, a magnetic anastomosis has demonstrated the ability to reduce anastomosis complications such as leaks and bleeding, however previous delivery methods required the creation an enterotomy with delayed anastomosis creation. We report the procedure feasibility and 30-day results of a first ever use in humans of a novel surgical technique that eliminates the need to close the enterotomies via conventional methods 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 consisted in creating an immediate communication in a side-to-side jejunal-jejunal anastomosis intraluminally through a novel temporary enterotomy control and capture (ECC) device. All devices were deployed and delivered laparoscopically.

Results

A total of 5 patients were recruited, with a mean age of 35.8 (27-43) years, sex-ratio (60 %F) and initial BMI of 44.8+-7.6 kg/m2 .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, completed in an anastomosis creation time of 10 minutes (enterotomy to magnet coupling). All ECC and SFMs passed with no retentions. A total of 1 procedure adverse events (AE) occurred due to poor tolerance to oral intake from gastro-jejunal anastomosis inflammation. 0 AE occurred during the 30-day follow up period.

Conclusions

Preliminary and procedure feasibility data of these new surgical techniques and devices suggest the procedures are both feasible and safe in RYGB surgery. Further and longer studies are warranted.