eP373 - PexyEazy® - A New Surgical Device for Treatment of Hemorrhoids; Device Description and Preclinical Data

Purpose/Background: PexyEazy® is a novel surgical device for the treatment of grade II and III hemorrhoids, designed to be quick and easy to learn, reduce postoperative pain, lower costs, and provide a good long-term outcome.Methods/Interventions: PexyEaxy® is based on mucopexy, where the hemorrhoids are lifted inward by sutures, restoring the normal position of the hemorrhoidal cushions. This improves venous drainage and decreases hemorrhoid swelling.
The PexyEazy® device has the diameter of a proctoscope but is slightly longer and has three openings along the sides, corresponding to the position of the three major internal hemorrhoids. Each opening consists of 5 indentations with small holes in the floor. When vacuum is applied, the mucosa above the hemorrhoids is folded when suctioned into the indentations. Double needles are thereafter pushed through the mucosa at each operation area and the needle tips dock with the ends of a suture stored at the tip of the device. As the needles are subsequentially withdrawn, a loop of suture is introduced through the folded mucosa. A supportive tray is thereafter removed, whereby internal components of the device fall apart and can be removed, with the sutures in place in the mucosa. The innermost indentation is larger and deeper, creating an anchoring stich that ensures the lifting effect inward when knots are applied with a knot pusher. Any protruding mucosa is pushed out with a small spatula, avoiding mucosal damage as the device is being removed.
Prior to the PeaxyEazy® procedure, a special proctoscope is used to mark the position of the dentate line. This depth setting is thereafter transferred to the PexyEazy® device, ensuring that the operation area is positioned 10mm above the dentate line where pain sensation is minimal, enabling surgery without anesthesia.

Mucopexy performed with PexyEazy® was studied in 9 anesthetized pigs (3-4 months old, 30-35kg). Following the procedure, the pigs were monitored for three hours, whereafter the rectum was removed for examination and measuring the lifting effect.Results/Outcomes: The entire PexyEazy® procedure was performed in less than 10 minutes. Small mucosal hematomas were detected, but no major bleeding. Of note, 26% if mucopexy areas had a rift in the mucosa closest to the dentate line. By measuring the difference of the length of the folded mucosa, and the unfolded mucosa, the lifting effect could be calculated. The mean lifting effect was 27 mm.Conclusion/

Discussion: Mucopexy performed with PexyEazy® had a significant lifting effect. In addition, sutures ran straight through the mucosa, which may provide better long-term results compared to manual mucopexy. The mucosa rifts noted in the porcine study are likely attributed to the firm piglet mucosa compared to the prolapsed mucosa of hemorrhoid patients.
PexyEazy® is a quick, simple, easy-to-learn, minimally invasive and hemorrhoid sparing method that may give results equal or better than manual mucopexy. We predict that PexyEazy® will be well tolerated by an awake patient, enabling a 10-minute office procedure, thereby reducing the overall cost.
PexyEazy® is currently undergoing a safety and feasibility study (SCI-Pex study), and a comparative randomized clinical investigation to assess long-term effects, is in planning.PexyEazy® deviceResult of PexyEazy® procedure.The rectum is excised and turned inside out. Length of running suture: 48,5mm. Length of muopexy: 19mm. Lifting effect is 29,5mm. Suture starts 11mm above the dentate line.Overview of the rectum after PexyEazy® procedureThe rectum is excised and turned inside out. The three mucopexies have a circumferential lifting effect.