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.


CONCLUSIONS
SIHM hernioplasty seems to be a safe and effective procedure.
Ansaloni
Luca
L
Unit of General, Emergency and Transplant Surgery, St. Orsola-Malpighi University Hospital, Bologna, Italy. luca.ansaloni@aosp.bo.it
Catena
Fausto
F
Coccolini
Federico
F
Gazzotti
Filippo
F
D'Alessandro
Luigi
L
Pinna
Antonio Daniele
AD
D000818:Animals; D001705:Bioprosthesis; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006552:Hernia, Inguinal / Q000401:mortality / Q000601:surgery*; D006801:Humans; D015994:Incidence; D007421:Intestine, Small / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000453:epidemiology; D011126:Polypropylenes; D011446:Prospective Studies; D012008:Recurrence; D018709:Statistics, Nonparametric; D013526:Surgical Mesh; D013552:Swine; D016896:Treatment Outcome
D011126:Polypropylenes