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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Incisional hernias repaired with mesh can be expected have a lower recurrence rate than with primary repair. Biologic implants have replaced synthetic meshes in certain complex settings. We compared two porcine-dermis derived implants--cross-linked Permacol™ biologic implant and non-cross linked Strattice-firm™ tissue matrix--in a ventral hernia animal model. Our hypothesis is that cross-linked biologic implants are remodeled differently and thus behave differently than non-cross-linked biologic implants. ⋯ Cross-linked materials may prove more durable in the remodeling process as suggested by the increased thinning and weakening observed in non-cross-linked biomesh.
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Randomized Controlled Trial Comparative Study
Preemptive analgesia with midazolam and diclofenac for hernia repair pain.
The aim of this study was to compare the preemptive effects of systemic midazolam and diclofenac on postoperative analgesia when used before surgical incision. ⋯ Midazolam enhances the postoperative analgesic effects of diclofenac when used before the onset of noxious stimuli.
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Randomized Controlled Trial Comparative Study
Risk factors for wound complications in midline abdominal incisions related to the size of stitches.
Midline abdominal incisions should be closed continuously with a suture length (SL) to wound length (WL) ratio above 4 using small stitches. The effect on the rate of wound complications of a very high ratio and other potential risk factors when closure is performed with small stitches is unknown. ⋯ In midline abdominal incisions closed with small stitches, no risk factors for surgical site infection or incisional hernia were identified. Increasing the ratio very much above 4 had no adverse effects on the rate of wound complications. The higher rates of infection and herniation with an SL to WL ratio over 5 and in overweight patients in previous reports were probably related to wounds being closed with large stitches.
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Groin herniorrhaphy is the most common operation performed by general surgeons. Annually, more than 20 million groin hernias are repaired worldwide. The general approach towards groin hernias is surgical repair regardless of the presence of symptoms. The rationale to recommend surgery for asymptomatic groin hernias is prevention of visceral strangulation. The goal of this review is to evaluate the appropriateness of surgery in patients with asymptomatic groin hernias. ⋯ Watchful waiting for asymptomatic groin hernias is a safe and cost-effective modality in patients who are under 50 years old, have an ASA class of 1 or 2, an inguinal hernia, and a duration of signs of more than 3 months.