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, R. Martindale, B. C. Stouch, Robert Joseph Fitzgibbons

Research output: Contribution to journalArticle

9 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
Pages (from-to)221-230
Number of pages10
JournalHernia : the journal of hernias and abdominal wall surgery
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

All Science Journal Classification (ASJC) codes

  • 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, R.; Stouch, B. C.; Fitzgibbons, Robert Joseph.

In: Hernia : the journal of hernias and abdominal wall surgery, Vol. 18, No. 2, 2014, p. 221-230.

Research output: Contribution to journalArticle

@article{d3c00dc3ed034c03a5d77cef1b4333e1,
title = "Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias",
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.",
author = "Bellows, {C. F.} and P. Shadduck and Helton, {W. S.} and R. Martindale and Stouch, {B. C.} and Fitzgibbons, {Robert Joseph}",
year = "2014",
doi = "10.1007/s10029-013-1076-9",
language = "English",
volume = "18",
pages = "221--230",
journal = "Hernia : the journal of hernias and abdominal wall surgery",
issn = "1265-4906",
publisher = "Springer Paris",
number = "2",

}

TY - JOUR

T1 - Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias

AU - Bellows, C. F.

AU - Shadduck, P.

AU - Helton, W. S.

AU - Martindale, R.

AU - Stouch, B. C.

AU - Fitzgibbons, Robert Joseph

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84898596970&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84898596970&partnerID=8YFLogxK

U2 - 10.1007/s10029-013-1076-9

DO - 10.1007/s10029-013-1076-9

M3 - Article

VL - 18

SP - 221

EP - 230

JO - Hernia : the journal of hernias and abdominal wall surgery

JF - Hernia : the journal of hernias and abdominal wall surgery

SN - 1265-4906

IS - 2

ER -