Electrospun P(LLA-CL) Nanoscale Fibrinogen Patch vs Porcine Small Intestine Submucosa Graft Repair of Inguinal Hernia in Adults: A Randomized, Single-Blind, Controlled, Multicenter, Non-Inferiority Trial.

OBJECTIVE To compare primary efficacy indicators of a low-cost, electrospun, nanoscale P(LLA-CL)/fibrinogen patch with a porcine small intestine submucosa patch for hernia repair. STUDY Design: A randomized, single-blind, controlled multicenter trial was performed in 3 hospitals in Shanghai. Eligible patients (20-75 years old) with primary unilateral reducible groin hernias were randomly assigned (1:1) to electrospun nanoscale P(LLA-CL)/fibrinogen patch (experimental group) or porcine small intestine submucosa (control group) patch groups. Patients were treated with the Lichtenstein technique and the primary endpoint was hernia recurrence at 33 months after surgery. The secondary endpoints were postoperative complications including groin pain and operative site infections. RESULTS Between July 2014 and February 2016, 172 patients were assigned to experimental (n = 86) and control (n = 86) groups. At 6 months follow-up, postoperative complications occurred in 5 patients (5/86, 5·95%) and 2 (2/86, 2·35%) patients in the control and experimental groups, respectively (P<0·05). At 33 months follow-up, recurrence was observed in 2 patients (2/79, 2·53%) in the control group vs none in the experimental group (0/78) (the 95% CI difference between the experimental and control groups was -0·93-6·00% and within the preset non-inferior margin of Δ10%). No significant differences were found in the degree of chronic pain and complications 33 months after surgery between the two groups. CONCLUSION Since the recurrence rates and postoperative complications after 33 months were not inferior in the experimental group, we believe that the P(LLA-CL)/fibrinogen patch as a low cost alternative has prospects for widespread clinical use.