• Acta Biomed · Jan 2003

    Randomized Controlled Trial Clinical Trial

    Prospective randomized, double-blind, controlled trial comparing Lichtenstein's repair of inguinal hernia with polypropylene mesh versus Surgisis gold soft tissue graft: preliminary results.

    • Luca Ansaloni, Fausto Catena, and Luigi D'Alessandro.
    • Department of Anesthesiological and Surgical Sciences, Unit of Emergency Surgery, Sant'Orsola-Malpighi Hospital, University of Bologna, Italy.
    • Acta Biomed. 2003 Jan 1;74 Suppl 2:10-4.

    IntroductionAlthough polypropylene mesh are the preferred prosthesis materials for the tension-free hernioplasties because they handle well and become quickly integrated, having reduced the recurrence rate below 1%, some problems with their use are still to be addressed (postoperative pain, long-term discomfort, infections, intestinal obstruction and fistulization). In order to answer to these disadvantages, a new degradable and reabsorbable material, the porcine small intestinal submucosa (SIS mesh gold, Surgisis), has recently been used in humans for laparoscopic hernia repairs. Aim to our study is to evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis gold soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.MethodsA prospective, randomised, double-blinded comparison of Lichtenstein's repair of inguinal hernia with polypropylene mesh versus Surgisis ES soft tissue graft was carried out at the Department of Emergency Surgery of St Orsola-Malpighi University Hospital with the participation of 4 surgeons who accept to standardise the Lichtenstein's procedures with the two different types of meshes.ResultsFrom july 2002 up to now 20 patients submitted to Lichtenstein's repair of inguinal hernia using Surgisis gold mesh with a 6 month minimum follow-up were enrolled. 12 subjects were treated with Surgisis ES mesh, while 8 were treated polypropylene mesh. There were not intraoperative or postoperatively complications. No recurrences and wound infections were observed. The post-hernioplasty acute and chronic pain/discomfort (tested with visual analogue scale and simple verbal scale) and parenteral/oral analgesic consumption were lower in Surgisis ES group.ConclusionsLichtenstein's hernioplasty using the Surgisis gold soft tissue graft has a promising safety and efficacy.

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