Assessing the Safety and Performance of The Easyendotm Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery: A Monocentric Post-Market Observational Study
Abstract
Willem Pype, Elodie Melsens, Pieter Van Aelst, Astrid Rycx, Dorien Haesen and Bruno Dillemans
Background: Laparoscopic Roux-en-Y gastric bypass (RYGB) has evolved into a leading treatment for obesity. The aim of this study was to assess the safety and the performance of the easyEndoTM Universal Linear Cutting Stapler and Reloads (EziSurg Medical CO., LTD, Shanghai, China) in laparoscopic RYGB surgery.
Methods:This prospective, non-randomized, registry recruited patients who underwent laparoscopic RYGB with the easyEndoTM Universal Linear Cutting Stapler. 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 frequency of re-interventions were evaluated as secondary outcomes.
Results: 150 patients (102 women and 48 men) underwent laparoscopic RYGB. The mean weight before RYGB was 116.26±19.50 kg, the body mass index (BMI) was 40.54±3.64 kg/m2 and the mean excess weight 44.77±13.70 kg. The operation could be successfully completed in all cases using the easyEndoTM Universal Linear Cutting Stapler. In 3.3% of cases (5/150) a pulsatile bleeding occurred that could be clipped and a staple line disruption occurred in 1.3% of cases (2/150) that was oversewn. No conversions to open laparotomy occurred. 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. Twenty-four months after RYGB, the average BMI dropped to 25.91±4.07 kg/m2, with a percentage excess weight loss (%EWL) of 95.74±26.59% and percentage total weight loss (%TWL) of 35.59±9.53%. A total of 19 post-operative complications occurred in 15 patients (10.0%), mainly internal herniation and small bowel obstruction. Re-interventions were needed in 11 patients (7.3%).
Conclusions: The 24-months follow-up data show that RYGB using the easyEndoTM Universal Linear Cutting Stapler and Reloads is safe and effective with significant weight loss and comparable complication rates according to the literature.