Hernia : the journal of hernias and abdominal wall surgery
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Randomized Controlled Trial Multicenter Study
The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair.
Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain. METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 men. These men are being followed for a minimum of 2 years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a Lichtenstein inguinal hernia repair as measured by resumption of activities of daily living. Secondary outcomes include chronic pain, postoperative complications and the incidence of re-herniation at 12 and 24 months. ⋯ We report the design of a multi-center, third-party blinded, randomized clinical trial comparing a new surgical device with existing technology in the repair of inguinal hernias. We believe this investigator-designed and conducted trial could serve as a model for similar trials examining surgical devices performed in collaboration with industry.
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Multicenter Study Comparative Study
Open tension-free Lichtenstein repair of inguinal hernia: use of fibrin glue versus sutures for mesh fixation.
To investigate pain and other complications following inguinal hernioplasty performed by the Lichtenstein technique with mesh fixation by fibrin glue or sutures. ⋯ Tissucol fibrin glue for mesh fixation in the Lichtenstein repair of inguinal hernia shows advantages over sutures, including lower incidence of complications such as pain, numbness, and discomfort, and should be considered as a first-line option for mesh fixation in hernioplasty.
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Randomized Controlled Trial Multicenter Study
Prolene Hernia System, Lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial. The BOOP study: bi-layer and connector, on-lay, and on-lay with plug for inguinal hernia repair.
Dissection requirements differ between various methods for inguinal hernia repair, which may affect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected following three principally different techniques for primary inguinal hernia repair. ⋯ All of the techniques are suitable for operation under local anaesthesia. The PHS and P techniques can be performed with shorter operation times than the L method. Early and late outcomes are, however, comparable, with no significant differences concerning complication rates, return to full functional status and/or pain response.
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Randomized Controlled Trial Multicenter Study Comparative Study
Recurrence and complications after laparoscopic versus open inguinal hernia repair: results of a prospective randomized multicenter trial.
The aim of this prospective randomized multicenter trial was to evaluate the recurrence rates and complications of open versus laparoscopic repairs of inguinal hernias. ⋯ In this multicenter study, no significant difference in the recurrence rate and complications between laparoscopic and open methods of hernia repair was revealed.
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Incarcerated abdominal wall hernia cases may necessitate emergency interventions, but under such circumstances morbidity and mortality rates may increase. The aim of this study was to investigate the factors that affect morbidity and mortality in patients with incarcerated abdominal wall hernias who underwent emergency surgery. ⋯ Intestinal necrosis, which was followed by bowel resection, was the sole factor affecting morbidity and mortality using multivariate logistic regression analysis. Emergency surgery is required for incarcerated abdominal wall hernias before intestinal necrosis develops.