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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 easyEndoTM 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 easyEndoTM 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 easyEndoTM 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.
Pype et al. (Fri,) studied this question.