COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

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

Luca Ansaloni, Fausto Catena, Federico Coccolini, Filippo Gazzotti, Luigi D'Alessandro, Antonio Daniele Pinna
American Journal of Surgery 2009, 198 (3): 303-12
19285658

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.

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