Safety and early results of immediately patent magnetic jejuno-jejunal anastomoses (IMPA-JJ) in Roux-en-Y gastric bypass.

INTRODUCTION

Bariatric surgery remains underutilized despite rising global obesity rates, with less than 2% of eligible patients undergoing procedures annually. Magnetic compression anastomosis (MCA) offers potential advantages over traditional techniques, including reduced operative time and improved healing. However, delayed patency has limited its application. This study evaluates the novel OTOLoc™ system, which enables immediate patency in Roux-en-Y gastric bypass (RYGB) via self-forming magnets (SFMs), addressing a key limitation of prior MCA approaches.

METHODS

A prospective, open-label, multicenter study (NCT06199635) was conducted across two centers (India and Chile). Fourteen patients with moderate-to-severe obesity underwent RYGB with SFM-assisted jejuno-jejunal anastomosis. Primary outcomes included 30-day freedom from anastomotic adverse events (AEs; leaks, bleeding, obstruction). Secondary outcomes encompassed weight loss, comorbidity resolution, and nutritional status. Technical success was defined as anastomosis creation without conversion to sutures/staplers.

RESULTS

All 14 procedures (median age: 42 years, BMI: 41.4 kg/m2) were technically successful, with a median operative time of 55 min and magnet placement time of 12 min. No device-related AEs occurred. Four procedure-related serious AEs (e.g., pulmonary embolism, gastro-jejunostomy bleeding) resolved without reoperation. At 3 months, median weight loss was 24.4 kg (21.2% total body weight loss), with no anastomotic complications. All magnets were excreted naturally within 30 days.

CONCLUSION

The OTOLoc™ system safely facilitated immediate-patency magnetic anastomoses in RYGB, with no device-related complications and promising short-term efficacy. Larger studies comparing SFMs to stapled anastomoses are warranted to validate these findings and assess long-term outcomes.