Abstract
BACKGROUND: Biologic mesh is a newly developed material for hernia repairs which has been successfully used in clinical practices. This study aims to evaluate the clinical efficacy between patients undergoing a Lichtenstein's hernioplasty with a new biologic mesh derived from porcine small intestine submucosal (SIS) extracellular matrix versus a standard SIS mesh. METHODS: A prospective, randomized, double-blinded, multi-center trial was conducted in a 6-month study. Lichtenstein hernioplasty was performed using the new SIS mesh (Beijing Biosis Healing Biotechnology) or the standard SIS mesh (Biodesign Surgisis, Cook Biotech). The postoperative follow-up examinations were carried out at during hospitalization, 1st week, 1st, 3rd, and 6th month after surgery. The primary outcome was the excellent and good rate of recovery. Secondary outcomes included recurrence rate, complications, and patient-centered outcomes. RESULTS: A total of 194 patients were randomized into experimental group receiving the new SIS mesh (n=97) and control group receiving the standard SIS mesh (n=97). The excellent and good rate of rehabilitation in the experimental group was 98.97%, while it was 100.00% in the control group (P>0.05). One patient had a recurrence in the experimental group, while there was no recurrence in the control group (P>0.05). Other clinical outcomes, including the length of operation or hospitalization, foreign body sensation in the inguinal area, incision healing, infection, postoperative chronic pain, postoperative allergy, hydrocele, and orchitis, were similar between the two groups. CONCLUSION: Lichtenstein hernioplasty using the SIS mesh was safe and effective, and the new SIS mesh tested in this study had comparable safety and efficacy to the wildly used SIS mesh.