ObjectiveTo evaluate the short-term safety and efficacy of domestic porcine small intestinal submucosal decellularized matrix (SIS) mesh in laparoscopic inguinal hernia repair (LIHR), and observe its clinical outcomes related to tissue repair. MethodsA multicenter open-label single-arm study included 169 patients undergoing LIHR with domestic SIS mesh. The primary assessment index was the excellent rate on postoperative Day 180, the secondary efficacy indexes were the hernia recurrence rate, incision healing rate, wound healing time, mesh infection, chronic pain, and discomfort at the repair site after the operation. ResultsAll surgeries were successfully completed, with the excellent rate was 100% on postoperative Day 180 which was significantly higher than the value of preset target (91%). The incision healing rate was 100%, and the median wound healing time was 8 days. 97.04% patients showed immediate painless after surgery, 98.20% patients were painless on postoperative Day 7, all patients were painless on postoperative Day 28. Immediately after the operation, 97.04% patients had no discomfort at the repair site, 98.20% patients had no discomfort on postoperative Day 7, all patients had no discomfort on postoperative Day 28. There was no recurrence or infection after operation. ConclusionDomestic SIS mesh is safe and effective in the laparoscopic treatment of inguinal hernia, and is worth popularizing for clinical use.
