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