A novel biologic graft composed of a non-crosslinked composite extracellular matrix derived from porcine urinary bladder matrix and small intestinal submucosa (UBM/SIS) has shown comparable effectiveness to lightweight synthetic mesh in laparoscopic inguinal hernia repair (LIHR), according to a recent multicenter, single-blinded, randomized controlled clinical trial. The four-year follow-up data suggests the UBM/SIS graft may also reduce the incidence of certain postoperative complications.
The study, involving 50 patients with unilateral primary inguinal hernia, randomly assigned participants to either the experimental group, receiving the UBM/SIS graft, or the control group, receiving a lightweight synthetic mesh. The primary endpoint was the effectiveness rate of hernia repair.
Results indicated no statistically significant difference in the effectiveness of hernia repair between the two groups (24/24 [100%] vs 21/22 [95.45%], RR, 0.4667; 95%CI, 0.3294-2.304; P = 0.4783). Notably, the experimental group reported no instances of fever, seroma, infection, groin pain, foreign body discomfort, or recurrence during the four-year follow-up. In contrast, the control group experienced two cases of seroma 14 days post-operation, one case of groin discomfort 60 days post-operation, and one recurrence 410 days after surgery.
Implications for Hernia Repair
These findings suggest that the novel UBM/SIS graft presents a viable alternative to synthetic mesh in LIHR, potentially offering a comparable effectiveness with a reduced risk of certain complications. The absence of recurrence and other complications in the UBM/SIS group over the four-year follow-up period warrants further investigation into the long-term benefits of this biologic graft.
Study Details and Limitations
The trial was registered with the Clinical Trials Registry (ChiCTR1800020173). While the results are promising, the study's sample size of 50 patients is a limitation. Further studies with larger cohorts and longer follow-up periods are needed to confirm these findings and fully elucidate the long-term outcomes associated with the UBM/SIS graft in LIHR.
