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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Editorial Practice Guideline
International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery.
To provide uniform terminology and definition of post-herniorrhaphy groin chronic pain. To give guidelines to the scientific community concerning the prevention and the treatment of chronic groin and testicular pain. ⋯ The consensus reached on some open questions in the field of post-herniorrhaphy chronic pain may help to better analyze and compare studies, avoid sending erroneous messages to the scientific community, and provide some guidelines for the prevention and treatment of post-herniorraphy chronic pain.
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The transinguinal preperitoneal (TIPP) technique uses a preperitoneal mesh preformed with a permanent memory ring, which greatly facilitates application of Rives' technique. The purpose of this retrospective study was to evaluate our primary results by systematic clinical and ultrasound evaluations more than 1 year after surgery. ⋯ It is feasible to correct a groin hernia using a preperitoneal preformed mesh with a permanent memory ring. Our study confirms the positive results of Pélissier and colleagues (Pélissier and Ngo, Ann Chir 131:590-594, 2006; Pélissier et al. J Chir 144(4):5S35-5S40, 2007; Pélissier et al. Hernia 11:229-234, 2007; Pélissier et al. Hernia 12:51-56, 2007) and Berrevoet et al. (Hernia 13:243-249, 2009; Langenbeck's Arch Surg 395:557-562, 2010) and is the first study to use a systematic clinical and ultrasound control more than 1 year after surgery. This technique has a low rate of complications, including ultrasound recurrence in 2% of patients without any clinical recurrence and chronic pain in 4.8% of patients who did not require the consumption of systematic painkillers and are not limited in their activities. This technique consisted of the placement of a patch in the preperitoneal space, which combines the benefits of the anterior approach (i.e., easy technique, short learning curve, low cost) and the preperitoneal placement of the mesh (less recurrence, less pain). This procedure is a good alternative to Lichtenstein's technique.
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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.