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

C. F. Bellows, P. Shadduck, W. S. Helton, Robert Martindale, B. C. Stouch, R. Fitzgibbons

Research output: Contribution to journalArticle

11 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)221-230
Number of pages10
JournalHernia
Volume18
Issue number2
DOIs
StatePublished - 2014

Fingerprint

Inguinal Hernia
Herniorrhaphy
Randomized Controlled Trials
Hernia
Postoperative Pain
Recurrence
Pain
Groin
Polypropylenes
Pain Measurement
strattice
Swine
Quality of Life
Morbidity
Transplants
Wounds and Injuries

Keywords

  • Biologic mesh
  • Inguinal hernia
  • Porcine dermis matrix

ASJC Scopus subject areas

  • Surgery
  • Medicine(all)

Cite this

Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias. / Bellows, C. F.; Shadduck, P.; Helton, W. S.; Martindale, Robert; Stouch, B. C.; Fitzgibbons, R.

In: Hernia, Vol. 18, No. 2, 2014, p. 221-230.

Research output: Contribution to journalArticle

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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.",
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AU - Martindale, Robert

AU - Stouch, B. C.

AU - Fitzgibbons, R.

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