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Self-Gripping Mesh Versus Fibrin Glue Fixation in Laparoscopic Inguinal Hernia Repair: a Randomized Prospective Clinical Trial in Young and Elderly Patients

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Self-Gripping Mesh Versus Fibrin Glue Fixation in Laparoscopic Inguinal Hernia Repair: a Randomized Prospective Clinical Trial in Young and Elderly Patients Open Med. 2016; 11: 497-508 Research Article Open Access Alessia Ferrarese*, Marco Bindi, Matteo Rivelli, Mario Solej, Stefano Enrico, Valter Martino Self-gripping mesh versus fibrin glue fixation in laparoscopic inguinal hernia repair: a randomized prospective clinical trial in young and elderly patients DOI 10.1515/med-2016-0087 Abbreviations and acronyms: TAPP = Transabdominal received August 12, 2016; accepted August 19, 2016 Pre-Peritoneal, ASA = American Society of Anesthesio- logy, BMI= Body Max Index, PM Group = Polypropyle- Abstract: Laparoscopic transabdominal preperitoneal ne-Mesh Group, SGM Group = Self-Gripping Mesh Group, inguinal hernia repair is a safe and effective technique. SD = Standard Deviation In this study we tested the hypothesis that self-gripping mesh used with the laparoscopic approach is comparable to polypropylene mesh in terms of perioperative compli- cations, against a lower overall cost of the procedure. We carried out a prospective randomized trial compar- 1 Introduction ing a group of 30 patients who underwent laparoscopic inguinal hernia repair with self-gripping mesh versus a Inguinal hernia is one of the most common diseases, with group of 30 patients who received polypropylene mesh an incidence of 700,000 cases each year in the United with fibrin glue fixation. States and a male-to-female preponderance of 9 to 1 [1,2]. Hernia repair is one of the most frequently performed There were no statistically significant differences general surgical procedures in the world [1]. between the two groups with regard to intraoperative var- Laparoscopic transabdominal hernia repair was first iables, early or late intraoperative complications, chronic performed in the early 1990s by F. Ger, in Germany [3-6], pain or recurrence. and consisted of nickel clips to close the defect through an Self-gripping mesh in transabdominal hernia repair was intra-abdominal approach. The first laparoscopic transab- found to be a valid alternative to polypropylene mesh in dominal pre-peritoneal hernia repair (TAPP) was per- terms of complications, recurrence and postoperative formed in 1992 in France by Arregui and Doin, who fixed pain. The cost analysis and comparability of outcomes a mesh in the peritoneal space after making an incision support the preferential use of self-gripping mesh. through the parietal peritoneum [7,8]. The advantages of laparoscopic over open mesh repair in terms of improved intraoperative diagnosis, better aes- Keywords: Inguinal hernia; Laparoscopic repair; thetic result and reduced postoperative pain have been Transabdominal hernia repair demonstrated in literature [9-13]. Laparoscopic inguinal hernia repair through a transabdominal preperitoneal approach has been described in literature as a difficult procedure; this diffi- *Corresponding author: Alessia Ferrarese, University of Turin, culty is linked to the intrinsic complexity of the anatom- Section of General Surgery, San Luigi Gonzaga Teaching Hospital, ical area to be dissected and also to the patient’s habitus Regione Gonzole 10, 10043 Orbassano, Turin, Italy, E-mail: alessia. and the characteristics of the abdominal wall defect [14]. [email protected] Laparoscopy is always performed under general anes- Marco Bindi, Matteo Rivelli, Mario Solej, Stefano Enrico, Valter Martino, University of Turin, Department of Oncology, School of Me- thesia and, according to some authors, carries a higher dicine, Teaching Hospital “San Luigi Gonzaga”, Section of General risk of intraoperative complications. Surgery, Orbassano, Turin, Italy © 2016 Alessia Ferrarese et al. published by De Gruyter Open This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivs 3.0 License. 498 A. Ferrarese et al. Current indications for laparoscopic repair are bilat- nique for applying self-gripping mesh in laparoscopic pro- eral inguinal hernias and recurrent hernias following a cedures [52]. previous anterior repair (grade B of recommendation) In 2012, Fumagalli et al. conducted a study to compare [15-22]. the TAPP approach with self-gripping mesh versus fixation Despite developments in prosthetic materials and with clips, and the authors concluded, within the limits of improvements to methods of fixation, polypropylene a retrospective study, that the use of self-gripping mesh mesh with fibrin glue fixation still sets the standard for could be a valid alternative to the other techniques [53]. laparoscopic repair [21,23-38]. In a retrospective study of 2012, Birk et al. concluded The use of fibrin glue to fix the mesh in hernia repair that laparoscopic hernia repair using self-gripping mesh was first described in 2001 by Katkhouda et al. using a pig was a rapid, effective and safe technique, with fewer cases model [39]. of recurrence and reduced incidence of chronic pain; they Numerous new meshes have been developed in recent reported that the costs of fixation systems required with years; however, none of these have been able to match other non-self-gripping meshes were superfluous [54]. polypropylene mesh for ease of handling and efficacy, nor The aim of this study was to compare laparoscopic can they replace it as the new gold standard [40-42]. surgical procedure using self-gripping mesh versus the One of the most recent meshes to have come onto the procedure using polypropylene mesh with fibrin glue market features a self-gripping technology. According to fixation. the literature, these self-gripping meshes have excellent The end point of the trial was to test the hypothesis properties of fixation and efficacy [43]; self-gripping mesh that self-gripping mesh is comparable to polypropylene is composed of a layer of large-pore polyester coated with mesh in terms of perioperative complications against a a layer of polylactic acid self-gripping micro hooks. The lower overall cost of the procedure in young and elderly mesh exhibits intrinsic and atraumatic fixation so to close (> 65 years old). the hernia safely and effectively, considerably reducing the level of chronic pain. In 2006 Chastan was the first to describe a new hernia repair procedure through the inguinal approach 2 Methods using a Velcro®-like self-gripping mesh without tacking systems [44]. 2.1 Study design Inadequate mesh fixation has been reported to be the main cause of recurrences following laparoscopic hernia This non-stratified, monocentric study with balanced ran- repair. domization (1:1) used a parallel group design to compare Chronic pain is an infrequent, but serious, potential the TAPP approach with self-gripping mesh to the TAPP complication of mesh fixation with tacks [49-51]. repair with polypropylene mesh with biological fibrin Tekit et al. described two instances in which further glue fixation. surgery was required due to debilitating pain following TAPP repair [46]. The International Endohernia Society (IEHS) guide- 2.2 Eligibility criteria lines of 2011 and European Hernia Society guidelines of 2009 defined endoscopic inguinal hernia techniques Patients eligible for inclusion were men with primary or as safe, providing specific technical steps are followed recurrent unilateral inguinal hernia, aged 25 to 70 years, [21,22]; in 2012 a randomized prospective study comparing with a BMI (body mass index) of < 18 and ASA (Ameri- TAPP versus totally extraperitoneal laparoscopic hernia can Society of Anesthesiology) class <= 3. The purpose of repair defined the two methods as similar in terms of recruiting a male-only cohort was to standardize the sur- overall perioperative outcome and found the totally extra- gical setting as far as possible in terms of anatomy and peritoneal approach to be significantly advantageous in technical problems encountered in performing the ingui- terms of postoperative pain. nal dissection. At the time of preparing the guidelines and conduct- Exclusion criteria were glaucoma, previous retinal ing the study cited above, there was no standardized tech- detachment or relevant cardiovascular co-morbidity. Laparoscopic inguinal hernia repair 499 2.3 Setting and two operating trocars. A preperitoneal pocket was created by performing medial, lateral and midline dis- The study was conducted at the General Surgery Unit, section with reduction of the hernial sac. In all cases, the Department of Oncology, San Luigi Gonzaga School of funicular elements were parietalized, and hemostasis was Medicine, University of Turin in Orbassano, Italy, between secured. 1 January 2014 and 1 January 2015. In all cases the mesh was cut to a size of 10 x 12 x 8 cm with incision of the funicular portion. Self-gripping mesh was inserted rolled up, and the polypropylene mesh was 2.4 Surgical procedures inserted flat; the latter was fixed using 1-2 cc of biological fibrin glue prepared by diluting the thrombin component Patients were randomized to receive laparoscopic ingui- in a ratio of 1:10 with respect to the fibrin after appropriate nal hernia repair with either self-gripping mesh or poly- thawing. propylene mesh with glue fixation. Self-gripping mesh was a lightweight, monofilament, two-dimensional mesh with an upper layer of resorbable 2.6 Variables evaluated polylactic acid micro hooks on the adhesive side. This was compared with a medium-weight, large-pore polypropyl- For both groups, we evaluated perioperative variables ene mesh fixed by means of 1-2 cc of biological fibrin glue. (operating time and postoperative length of hospital The procedures were performed by two surgeons, stay), intraoperative complications (vascular lesions, both of whom were specialists
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