Assessing the safety and performance of the easyEndoTM Universal Linear Cutting Stapler in laparoscopic gastric bypass surgery: a monocentric post-market observational study.

Abstract

Purpose: Laparoscopic Roux-en-Y gastric bypass (RYGB) is a key treatment for obesity. This study aimed to assess the safety and performance of the easyEndo^TM Universal Linear Cutting Stapler and Reloads (EziSurg Medical CO., LTD, Shanghai, China) in laparoscopic RYGB. Methods: Adult patients undergoing laparoscopic RYGB were recruited. The primary endpoint was to evaluate the occurrence of peri- and post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding. Patient’s weight loss, primary technical success of the procedure, device performance, complications and re-interventions were evaluated as secondary outcomes. Results: One hundred and fifty patients successfully underwent laparoscopic RYGB using the easyEndo^TM Universal Linear Cutting Stapler. Mean weight pre-RYGB was 116.26±19.50 kg, body mass index (BMI) was 40.54±3.64 kg/m² and mean excess weight was 44.77±13.70 kg. Pulsatile bleeding occurred in 3.3% of cases that could be clipped, and staple line disruption in 1.3% that was oversewn. Primary technical success was 90.7%. Regarding the primary endpoint, 1 post-operative bleeding occurred on the gastrojejunostomy created by a circular stapler. Post-operative melaena occurred in 3 patients. At 24 months, average BMI dropped to 25.91±4.07 kg/m², with a percentage excess weight loss (%EWL) of 95.74±26.59% and a percentage total weight loss (%TWL) of 35.59±9.53%. Nineteen post-operative complications occurred in 15 patients (10.0%), mainly internal herniation and small bowel obstruction. Re-interventions were required in 11 patients (7.3%). Conclusion: RYGB with the easyEndo^TM Universal Linear Cutting Stapler and Reloads is safe and effective with significant weight loss and comparable complication rates to existing literature. Prospectively registered at ClinicalTrials.gov (NCT03968757) in May2019.