Inguinal hernia repair with porcine small intestine submucosa: 3-year follow-up results of a randomized controlled trial of Lichtenstein's repair with polypropylene mesh versus Surgisis Inguinal Hernia Matrix.

BACKGROUND: The aim of this study was to evaluate the safety and efficacy of Lichtenstein's hernioplasty using Surgisis Inguinal Hernia Matrix (SIHM; Cook, Bloomington, Indiana) compared with polypropylene (PP; Angiologica, Pavia, Italy). METHODS: This was a prospective, randomized, double-blind trial comparing Lichtenstein's inguinal hernioplasty using SIHM versus PP. RESULTS: Seventy male patients underwent Lichtenstein's hernioplasty (n = 35 in the SIHM group and n = 35 in the PP group). At 3 years after surgery, there were 2 deaths (5.7%) in the PP group and 1 death (2.9%) in the SIHM group (not significant [NS]). Although the study was underpowered to evaluate the recurrence rate, only 1 recurrence (2.9%) was seen in the PP group (NS). Although a significant decrease in postsurgical pain incidence was never observed among patients in the SIHM group, a significantly lower degree of pain was detected at rest and on coughing at 1, 3, and 6 months and on movement at 1, 3, and 6 months and 1, 2, and 3 years. A significant decrease in postsurgical incidence and degree of discomfort when coughing and moving were observed among patients in the SIHM group at 3 and 6 months and at 1, 2, and 3 years after surgery. COMMENTS: SIHM hernioplasty seems to be a safe and effective procedure.