Recurrence and complications after laparoscopic versus open inguinal hernia repair: results of a prospective randomized multicenter trial

Background The aim of this prospective randomized multicenter trial was to evaluate the recurrence rates and complications of open versus laparoscopic repairs of inguinal hernias. Methods Patients with primary unilateral inguinal hernias were randomized to Shouldice repair, Bassini operation, tension-free hernioplasty (Lichtenstein repair), laparoscopic transabdominal extraperitoneal hernioplasty (TEP), or laparoscopic transabdominal preperitoneal hernioplasty ( TAPP). The primary outcome parameter was the rate of recurrence at 3 years. The secondary outcome was the rate of intraoperative, perioperative, and long-term complications. Follow-up comprised of clinical examination after 1, 2, and 3 years. Results Three hundred and sixty-five patients were randomly assigned to one of the five procedures. The intention-to-treat analysis showed that the cumulative 3-year recurrence rate was 3.4% in the Bassini group, 4.7% in the Shouldice group, 0% in the Lichtenstein group, 4.7% in the TAPP group, and 5.9% in the TEP group (p = 0.48). Comparing open ( Bassini, Shouldice, Lichtenstein) versus laparoscopic (TAPP, TEP) techniques (p = 0.29) and comparing the use of mesh prostheses (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) (p = 0.74) showed no significance in the rate of recurrence. The rates of intraoperative (p = 0.15), perioperative (p = 0.09), and long-term complications (p = 0.13) were without significance between the five groups. Comparing mesh techniques ( Lichtenstein, TAPP, TEP) versus suturing techniques ( Bassini, Shouldice) showed no significance in the rate of complications. The per-protocol analysis for the comparison of mesh ( Lichtenstein, TAPP, TEP) versus suturing ( Bassini, Shouldice) techniques revealed that recurrences (p = 0.74), intraoperative (p = 0.64), perioperative (p = 0.27), and long-term complications (p = 0.91) were evenly distributed. Conclusions In this multicenter study, no significant difference in the recurrence rate and complications between laparoscopic and open methods of hernia repair was revealed.