The impact of atraumatic fibrin sealant vs. staple mesh fixation in TAPP hernia repair on chronic pain and quality of life: results of a randomized controlled study.
ABSTRACT Mesh reinforcement has become the standard of care in the open and laparoscopic repair of inguinal hernia. Chronic pain after inguinal hernia repair is often due to nerve injury by penetrating mesh fixation devices such as staples (ST), tacks, or sutures. In several studies on hernioplasty, atraumatic mesh fixation with fibrin sealant (FS) proved to be efficient in terms of fixation strength and elasticity. Unfortunately, most of these studies did not provide a standardized follow-up and assessment of the development of chronic pain (CP) and the quality of life (QoL). Therefore, a randomized controlled trial comparing CP and QoL after FS fixation of mesh with ST in transabdominal preperitoneal hernioplasty (TAPP) was performed at our department. The primary end point of our study was to assess the patient outcome by using a visual analog scale (VAS) and the short form 36 (SF-36). The evaluation of recurrence rates was the secondary aim.
According to the randomization, a macroporous mesh (TiMESH(®)) was fixed in group A (44 patients with 54 inguinal hernias) with FS (TISSEEL) or in group B (45 patients with 56 inguinal hernias) with ST (EMS(®) Stapler). The observation period was 1 year with regular clinical check ups and assessment of VAS and SF-36.
Patient characteristics expressed by BMI, ASA scores, and Schumpelick hernia classification were similar in both treatment groups. In each group there was one recurrence within 8 (FS) and 9 months (ST) postsurgery. The mean preoperative pain values scored by VAS were 1.7 (range = 0-7.5) in the FS group and 2.2 (range = 0-6) in the ST group. Postoperative mean VAS scores measured at 1 year postsurgery were 0.4 (range = 0-3) in the FS group and 0.9 (range = 0-7.5) in the ST group. One year postsurgery there was no significant difference between the two groups with respect to the parameter pain in the SF-36 and VAS.
Fibrin sealant fixation leads to a low rate of hernia recurrence and avoids tissue trauma. ST provide similar results in the hand of the expert but bear inherent risks of complications due to tissue perforation.
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ABSTRACT: The aim of this study was to conduct a comprehensive systematic review comparing tissue glue (TG) against tacks/staples for mesh fixation in laparoscopic (totally extra-peritoneal and trans-abdominal pre-peritoneal) groin hernia repair with the incidence of post-operative chronic pain as the primary outcome measure. A computerized search of MEDLINE, EMBASE, and Cochrane databases for the period from 1 January 1,990 to 30 June 2013 produced 39 reports. The quality of reports was assessed according to criteria reported by the Cochrane communication review group. Five randomized controlled trials (RCTs, 491 patients) and five non-RCTs (1,034 patients) fulfilled the selection criteria. A meta-analysis of chronic pain from the five RCTs gave a statistically significant Peto odds ratio (OR) of 0.40 (0.21-0.76; p = 0.005) indicating that the TG group experience less chronic pain. Although the studies are underpowered to detect recurrence, the meta-analysis of the recurrence rates from the RCTs identified no difference between tacks/staple and glue fixation (OR 2.36; 0.67-8.37). There were also no differences found in meta-analysis of seroma and hematoma formation between the two methods of fixation. The wide variation in time points regarding pain score meant it was not possible to combine the studies and perform analysis for pain score with earlier time points. Meta-analysis of RCTs comparing TG with tack fixation in laparoscopic inguinal hernia surgery depicts a significant reduction in chronic pain with no increase in recurrence rates. Early post-operative outcome is similar after both methods of mesh fixation, although larger RCTs are required, with long-term pain as the primary endpoint.World Journal of Surgery 04/2014; · 2.23 Impact Factor
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ABSTRACT: Background. Fibrin sealant became the first modern era material approved as a hemostat in the United States in 1998. It is the only agent presently approved as a hemostat, sealant, and adhesive by the Food and Drug Administration (FDA). The product is now supplied as patches in addition to the original liquid formulations. Both laboratory and clinical uses of fibrin sealant continue to grow. The new literature on this material also continues to proliferate rapidly (approximately 200 papers/year). Methods. An overview of current fibrin sealant products and their approved uses and a comprehensive PubMed based review of the recent literature (February 2012, through March 2013) on the laboratory and clinical use of fibrin sealant are provided. Product information is organized into sections based on a classification system for commercially available materials. Publications are presented in sections based on both laboratory research and clinical topics are listed in order of decreasing frequency. Results. Fibrin sealant remains useful hemostat, sealant, and adhesive. New formulations and applications continue to be developed. Conclusions. This agent remains clinically important with the recent introduction of new commercially available products. Fibrin sealant has multiple new uses that should result in further improvements in patient care.ISRN surgery. 01/2014; 2014:203943.
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ABSTRACT: In 2009, the European Hernia Society published the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. The guidelines expired January 1, 2012. To keep them updated, a revision of the guidelines was planned including new level 1 evidence.The original Oxford Centre for Evidence-Based Medicine ranking was used. All relevant level 1A and level 1B literature from May 2008 to June 2010 was searched (Medline and Cochrane) by the Working Group members. All chapters were attributed to the two responsible authors in the initial guidelines document. One new chapter on fixation techniques was added. The quality was assessed by the Working Group members during a 2-day meeting and the data were analysed, especially with respect to any change in the level and/or text of any of the conclusions or recommendations of the initial guidelines. In the end, all relevant references published until January 1, 2013 were included. The final text was approved by all Working Group members.For the following topics, the conclusions and/or recommendations have been changed: indications for treatment, treatment of inguinal hernia, day surgery, antibiotic prophylaxis, training, postoperative pain control and chronic pain. The addendum contains all current level 1 conclusions, Grade A recommendations and new Grade B recommendations based on new level 1 evidence (with the changes in bold).Despite the fact that the Working Group responsible for it tried to represent most kinds of surgeons treating inguinal hernias, such general guidelines inevitably must be fitted to the daily practice of every individual surgeon treating his/her patients. There is no doubt that the future of guideline implementation will strongly depend on the development of easy to use decision support algorithms tailored to the individual patient and on evaluating the effect of guideline implementation on surgical outcome. At the 35th International Congress of the EHS in Gdansk, Poland (May 12–15, 2013), it was decided that the EHS, IEHS and EAES will collaborate from now on with the final goal to publish new joint guidelines, most likely in 2015.Hernia 04/2014; · 1.69 Impact Factor