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

American Journal of Surgery

Volumn 198, Issue 3, 2009, Pages 303-312

  Ansaloni, Luca ^a   Catena, Fausto ^a   Coccolini, Federico ^a   Gazzotti, Filippo ^a   D'Alessandro, Luigi ^a   Pinna, Antonio Daniele ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

Biologic prostheses; Hernia; Polypropylene; Recurrence; Surgisis

Indexed keywords

GLUCOSE; NIMESULIDE; POLYPROPYLENE; SODIUM CHLORIDE;

ADULT; ARTICLE; BODY MOVEMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DEATH; DOUBLE BLIND PROCEDURE; FOLLOW UP; HEMATOMA; HERNIOPLASTY; HUMAN; HYPERPYREXIA; INGUINAL HERNIA; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; POSTOPERATIVE ANALGESIA; POSTOPERATIVE PAIN; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; REST; SAFETY; SEROMA; SMALL INTESTINE; SUBMUCOSA; SURGICAL EQUIPMENT; TISSUE GRAFT; VISUAL ANALOG SCALE;

ANIMALS; BIOPROSTHESIS; DOUBLE-BLIND METHOD; FOLLOW-UP STUDIES; HERNIA, INGUINAL; HUMANS; INCIDENCE; INTESTINE, SMALL; MALE; MIDDLE AGED; PAIN MEASUREMENT; PAIN, POSTOPERATIVE; POLYPROPYLENES; PROSPECTIVE STUDIES; RECURRENCE; STATISTICS, NONPARAMETRIC; SURGICAL MESH; SWINE; TREATMENT OUTCOME;

EID: 69249231066     PISSN: 00029610     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjsurg.2008.09.021     Document Type: Article

References (42)

1. Collaboration E.H. Mesh compared with non-mesh methods of open groin hernia repair: systematic review of randomized controlled trials. Br J Surg 87 (2000) 854-859
2. Scott N.W., McCormack K., Graham P., et al. Open mesh versus non-mesh for repair of femoral and inguinal hernia. Cochrane Database Syst Rev 4 (2002) CD002197
3. Leber G.E., Garb J.L., Alexander A.I., et al. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 133 (1998) 378-382
4. Engelsman A.F., van der Mei H.C., Ploeg R.J., et al. The phenomenon of infection with abdominal wall reconstruction. Biomaterials 28 (2007) 2314-2327
5. Delikoukos S., Tzovaras G., Liakou P., et al. Late-onset deep mesh infection after inguinal hernia repair. Hernia 11 (2007) 15-17
6. Condon R.E. Groin pain after hernia repair. Ann Surg 233 (2001) 8
7. Bay-Nielsen M., Perkins F.M., and Kehlet H. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg 233 (2001) 1-7
8. EU Hernia Trialists Collaboration. Repair of groin hernia with synthetic mesh: meta-analysis of randomized controlled trials. Ann Surg 235 (2002) 322-332
9. Tyrell J., Silberman H., Chandrasoma P., et al. Absorbable versus permanent mesh in abdominal operations. Surg Gynecol Obstet 168 (1989) 227-232
10. Vaught J.D., Kropp B.P., Sawyer B.D., et al. Detrusor regeneration in the rat using porcine SIS graft: functional innervation and receptor expression. J Urol 155 (1996) 374-378
11. Hiles M., and Hodde J. Tissue engineering a clinically useful extracellular matrix biomaterial. Int Urogynecol J Pelvic Floor Dysfunct 17 suppl 1 (2006) S39-S43
12. Hodde J. Extracellular matrix as a bioactive material for soft tissue reconstruction. ANZ J Surg 76 (2006) 1096-1100
13. Franklin Jr. M.E., Treviño J.M., Portillo G., et al. The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc 22 (2008) 1941-1946
14. Edelman D.S. Laparoscopic herniorraphy with porcine SIS: a preliminary study. JSLS 6 (2002) 203-205
15. Catena F., Ansaloni L., Leone A., et al. Lichtenstein repair of inguinal hernia with Surgisis inguinal hernia matrix soft-tissue graft in immunodepressed patients. Hernia 9 (2005) 29-31
16. Agresta F., and Bedin N. Transabdominal laparoscopic inguinal hernia repair: is there a place for biological mesh?. Hernia 12 (2008) 609-612
17. Puccio F., Solazzo M., and Marciano P. Comparison of three different mesh materials in tension-free inguinal hernia repair: prolene versus Vypro versus surgisis. Int Surg 90 3 suppl (2005) S21-S23
18. Ansaloni L., Catena F., Gagliardi S., et al. Hernia repair with porcine small-intestinal submucosa. Hernia 11 (2007) 321-326
19. Ansaloni L., Catena F., and D'Alessandro L. Prospective randomized, double-blind, controlled trial comparing Lichtenstein's repair of inguinal hernia with polypropylene mesh versus Surgisis gold soft tissue graft: preliminary results. Acta Biomed Ateneo Parmense 74 suppl 2 (2003) 10-14
20. Zollinger Jr. R.M. An updated traditional classification of inguinal hernias. Hernia 8 (2004) 318-322
21. Lichtenstein I.L., Shulman A.G., Amid P.K., et al. The tension-free hernioplasty. Am J Surg 157 (1989) 188-193
22. Price D.D., Bush F.M., Long S., et al. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 56 (1994) 217-226
23. Mangram A.J., Horan T.C., Pearson M.L., et al. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control 27 (1999) 97-132
24. Prevel C.D., Eppley B.L., Summerlin D.J., et al. Small intestinal submucosa: use in repair of rodent abdominal wall defects. Ann Plast Surg 35 (1995) 374-380
25. Clarke K.M., Lantz G.C., Salisbury S.K., et al. Intestine submucosa and polypropylene mesh for abdominal wall repair in dogs. J Surg Res 60 (1996) 107-114
26. Badylak S., Kokini K., Tullius B., et al. Strength over time of a resorbable bioscaffold for body wall repair in a dog model. J Surg Res 99 (2001) 282-287
27. Badylak S., Kokini K., Tullius B., et al. Morphologic study of small intestinal submucosa as a body wall repair device. J Surg Res 103 (2002) 190-202
28. Soiderer E.E., Lantz G.C., Kazacos E.A., et al. Morphologic study of three collagen materials for body wall repair. J Surg Res 118 (2004) 161-175
29. Trabuco E.C., Zobitz M.E., Klingele C.J., et al. Effect of host response (incorporation, encapsulation, mixed incorporation and encapsulation, or resorption) on the tensile strength of graft-reinforced repair in the rat ventral hernia model. Am J Obstet Gynecol 197 (2007) 638.e1-638.e6
30. Claerhout F., Verbist G., Verbeken E., et al. Fate of collagen-based implants used in pelvic floor surgery: a 2-year follow-up study in a rabbit model. Am J Obstet Gynecol 198 (2008) 94.e1-94.e6
31. Ueno T., Pickett L.C., de la Fuente S.G., et al. Clinical application of porcine small intestinal submucosa in the management of infected or potentially contaminated abdominal defects. J Gastrointest Surg 8 (2004) 109-112
32. Oelschlager B.K., Barreca M., Chang L., et al. The use of small intestine submucosa in the repair of paraesophageal hernias: initial observations of a new technique. Am J Surg 186 (2003) 4-8
33. Helton W.S., Fisichella P.M., Berger R., et al. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Arch Surg 140 (2005) 549-560
34. Allman A.J., McPherson T.B., Badylak S.F., et al. Xenogeneic extracellular matrix grafts elicit a TH2-restricted immune response. Transplantation 71 (2001) 1631-1640
35. Galili U. The alpha-gal epitope and the anti-Gal antibody in xenotransplantation and in cancer immunotherapy. Immunol Cell Biol 83 (2005) 674-686
36. McPherson T.B., Liang H., Record R.D., et al. Galalpha(1,3)Gal epitope in porcine small intestinal submucosa. Tissue Eng 6 (2000) 233-239
37. Raeder R.H., Badylak S.F., Sheehan C., et al. Natural anti-galactose alpha1,3 galactose antibodies delay but does not prevent the acceptance of extracellular matrix xenografts. Transpl Immunol 10 (2002) 15-24
38. Ansaloni L., Cambrini P., and Catena F. Immune response to small intestinal submucosa (Surgisis) implant in humans: preliminary observations. J Invest Surg 20 (2007) 237-241
39. Palmer E.M., Beilfuss B.A., Nagai T., et al. Human helper T cell activation and differentiation is suppressed by porcine small intestinal submucosa. Tissue Eng 8 (2002) 893-900
40. Page B., Paterson C., Young D., et al. Pain from primary inguinal hernia and the effect of repair on pain. Br J Surg 89 (2002) 1315-1318
41. Callesen T., Bech K., and Kehlet H. Prospective study of chronic pain after groin hernia repair. Br J Surg 86 (1999) 1528-1531
42. Courtney C.A., Duffy K., Serpell M.G., et al. Outcome of patients with severe chronic pain following repair of groin hernia. Br J Surg 89 (2002) 1310-1314