, Volume 18, Issue 2, pp 221-230

Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias

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Abstract

Purpose

Biologic grafts are rarely used for inguinal herniorrhaphy. The aim of this study was to compare the clinical outcomes between patients undergoing a Lichtenstein’s hernioplasty with a porcine mesh versus a standard synthetic.

Methods

A prospective, randomized, double-blinded multicenter, evaluation of inguinal hernia repair was conducted between 2008 and 2010. Lichtenstein hernioplasty was performed using Strattice™ or lightweight polypropylene (Ultrapro) mesh. Quality of life, pain, overall complication rate, and recurrence were measured.

Results

One hundred and seventy-two patients were randomized to Strattice™ (n = 84) or Ultrapro (n = 88). At 3 months postoperatively, there were no differences on the occurrence or type of wound events [RR: 0.98 (95 % CI 0.52–1.86, p = 0.69), Strattice™ (15 events) vs. Ultrapro (16 events)]. The mean level of impairment caused by the hernia, assessed by Activities Assessment Scale (AAS), significantly decreased postoperatively in both groups at 3 months (31 % Strattice™ and 37 % Ultrapro). Patients in the Strattice group reported significantly less postoperative pain during postoperative days 1 through 3 compared to Ultrapro patients. However, the amount of postoperative pain at 3 months, as assessed by the mean worst pain score on a visual analog scale and the Brief Pain Index, was similar between groups (95 % CI 1.0–29.3). No hernia recurrences were observed in either group.

Conclusions

Strattice™ is safe and effective in repairing inguinal hernia, with comparable intra-operative and early postoperative morbidity to synthetic mesh. Long-term follow-up is necessary in order to know whether the clinical outcomes of Strattice are equivalent to standard synthetic mesh in patients undergoing Lichtenstein’s hernioplasty.

Trial Registration clinicaltrials.gov Identifier: NCT00681291.