DiVerent methods of mesh Wxation in open retromuscular incisional hernia repair: a comparative study in pigs

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1 Hernia (2010) 14: DOI /s ORIGINAL ARTICLE DiVerent methods of mesh Wxation in open retromuscular incisional hernia repair: a comparative study in pigs J. Grommes M. Binnebösel C. D. Klink K. T. von Trotha K. Junge J. Conze Received: 21 June 2010 / Accepted: 26 August 2010 / Published online: 12 September 2010 Springer-Verlag 2010 Abstract Purpose Reinforcement of the abdominal wall with alloplastic mesh material in incisional hernia repair is well established. To avoid dislocation and migration of the prostheses, mesh Wxation is recommended. However, there seems to be a correlation between postoperative pain and mesh Wxation. Furthermore, it remains unclear whether mesh Wxation is necessary at all. Methods A retromuscular mesh implantation was performed in 36 pigs using a polypropylene-polyglecaprone 25 composite mesh (Ultrapro, cm). In group 1, the mesh was Wxed to the posterior rectus sheet with non absorbable single sutures (Prolene 2-0), in group 2 Wxation was with absorbable sutures (Vicryl 2-0), in group 3 mesh Wxation was with 5 ml Wbrin sealant (Quixil ), and, as a control, there was no Wxation in group 4. The abdominal wall was explanted on postoperative day 7, 14 and 56. Mesh size and position was measured, and pull-out force of the mesh was analysed mechanically by tensiometry. The ratio of collagen type I/III was analysed to determine the quality of mesh integration. Results Neither mesh dislocation nor mesh migration was detected. Mesh size showed no signiwcant diverences, whether comparing time points or groups. No signiwcant diverences in the tensile strength of mesh integration were found when comparing the groups (group 1: mmhg; group 2: mmhg; group 3: mmhg; J. Grommes (&) Department of Vascular Surgery, University Hospital of RWTH Aachen, Pauwelsstr 30, Aachen, Germany jgrommes@ukaachen.de M. Binnebösel C. D. Klink K. T. von Trotha K. Junge J. Conze Department of Surgery, University Hospital of RWTH Aachen, Aachen, Germany group 4: mmhg). Though the type I/III collagen ratio increased over time, no signiwcant diverences according to the type of Wxation used were detected. Conclusion Mesh Wxation in open incisional hernia repair with retromuscular mesh augmentation to avoid mesh dislocation or migration in the early postoperative period appears to be unnecessary. Keywords Mesh Wxation Retromuscular mesh augmentation Mesh dislocation Shrinkage Introduction Incisional hernia after laparotomy is one of the most common postoperative complications in surgery, with an incidence of 11 20% depending on the follow-up [1]. Simple suture repair has a recurrence rate of up to 60% depending on the length of follow up and should no longer be performed [2]. The introduction of alloplastic materials has led to improved results, with a recurrence rate of approximately 5% depending on the implantation technique [3]. In open mesh repair for incisional hernia, retromuscular mesh augmentation, i.e. using the mesh to reinforce the abdominal wall, has become the standard procedure giving the best results [4]. Following hernia repair, a lot of patients suver pain and foreign body sensations [5 7]. Other than the mesh material itself, the kind and amount of Wxation is discussed as possible reason for postoperative pain [8, 9]. In open incisional hernia repair with mesh augmentation there is still no consensus on how much mesh Wxation is needed. Without any scientiwc basis, most mesh companies suggest tight mesh Wxation with non absorbable sutures, placed at a maximum distance of not more than 2 cm to each other, to avoid mesh migration and dislocation. These

2 624 Hernia (2010) 14: sutures can be placed onto the posterior rectus sheath or transfascial through the muscle. Recently, new techniques with Wbrin sealant have been introduced and discussed [10 14]. To investigate the necessity for mesh Wxation in incisional hernia repair, we performed an experimental study comparing diverent Wxation techniques in a standardised pig model. Materials and methods The experiments were oycially approved by the State OYce for Nature, the Environment and Consumer Protection Cologne, Germany (Landesamt für Natur, Umwelt und Verbraucherschutz Köln; reference number: ). All animals received humane care in accordance with the requirements of the German Animal Protection Act (Tierschutzgesetz), 8 Article 1 and in accordance with the Guide for the Care and Use of Laboratory Animals published by the German National Institute of Health. Thirty-six male pigs with a mean body weight of 70 kg were divided randomly into four groups: Group 1 (n = 9): Open retromuscular mesh augmentation with non absorbable suture Wxation (polypropylene, Prolene 2-0, Ethicon, Somerville, NJ). Group 2 (n = 9): Open retromuscular mesh augmentation with absorbable suture Wxation (polyglactin, Vicryl 2-0, Ethicon). Group 3 (n = 9): Open retromuscular mesh augmentation with Wbrin sealant mesh Wxation (5 ml Quixil, Ethicon; use of Quixil for mesh Wxation corresponds to ov-label use) Group 4 (n = 9): Open retromuscular mesh augmentation with no Wxation. The implanted mesh prosthesis was a large pore, low weight polypropylene-polyglecaprone 25 composite mesh (Ultrapro, Ethicon). All animals were kept under standardised conditions: temperature between 22 and 24 C; relative humidity 50 60%; 12 h light followed by 12 h darkness. The animals had free access to food and water, although food was withdrawn for 12 h before and after surgery. All operations were carried out under general anaesthesia and using aseptic and sterile surgical conditions. Surgical procedure After induction with a subcutaneous mixture of 0.3 mg/kg medetomidine (Domitor, PWzer, Zurich, Switzerland) and ketamine hydrochloride 100 mg/kg (Ketamin 10%, SanoW-Ceva, Düsseldorf, Germany), general anaesthesia was performed with isoxurane (Attane, MINRAD, BuValo, NY) insuzation. The skin was shaved and disinfected with polyvidone-iodine solution (Braunosan Vet, Braun Vet Care, Tuttlingen, Germany). The animals were Wxed in a supine position. Laparotomy was performed by a 15 cm midline incision, always beginning 5 cm caudal to the xiphoid. The retromuscular cavity of the rectus sheath was dissected at least 5 cm to each side. To facilitate suycient mesh subduction in the midline cranial and caudal to the created fascial defect, the posterior rectus sheath was incised on both sides of the linea alba. After closing the peritoneum and the dorsal blade of the rectus sheath with a continuous suture (polyglactin, Vicryl 2-0), an cm polypropylene-polyglecaprone 25 composite mesh (Ultrapro, Ethicon) was positioned in the retromuscular position. In the animals of group 1, mesh Wxation was performed with polypropylene 2-0 sutures (Prolene, Ethicon) with a distance of 2 cm between each stitch at the border of the mesh on the posterior rectus sheath. Similarly, in group 2, Wxation was carried out with polyglactin 2-0 (Vicryl, Ethicon) with a distance of 2 cm between each stitch. In group 3, mesh Wxation was conducted using 5 ml Wbrin sealant (Quixil, Ethicon) applied with a syringe. In order to serve as control, in group 4, meshes were not Wxed. The ventral fascia was closed in front of the mesh with an absorbable loop suture (polyglactin, Vicryl 1-0) and the skin was closed with polyglactin 2-0 single sutures (Vicryl, Ethicon). Three animals in each group were sacriwced on postoperative day 7, 14 and 56. The abdominal wall was excised following euthanasia by an overdose of medetomidine (Domitor, PWzer) and ketamine hydrochloride (Ketamin 10%, SanoW-Ceva). After explantation of the abdominal wall, the width and length of the mesh was measured. The force required to extract the mesh was measured by a load cell (tensiometry). Tensiometry included load cell (KD 9363s ME-System, Hennigsdorf, Germany), ampliwer (GSV-11H ME-System, Hennigsdorf, Germany), USB board motor control (National Instruments Germany, Munich, Germany), and a personal computer with the LabView software (National Instruments). LabView tool was programmed by haitecon (Stuttgart, Germany). For tensiometry, a strip of mesh carrying an equivalent part of the abdominal wall with a size of 5 12 cm was separated. The incorporated mesh was mobilised with a surface of 5 6 cm on one site, clamped and connected with the load cell (tensiometer). The other side of the abdominal wall was Wxed within the measurement setup without clamping the mesh. The force necessary to extract the mesh from the tissue was registered by LabView (National Instruments) and was measured in Newtons (N). This procedure was

3 Hernia (2010) 14: performed twice with two samples of each explanted mesh. Tissue specimens for histology were explanted separately, Wxed immediately in 4% paraformaldehyde and embedded in parayn wax. Histological assessment Morphological, histological and immuno-histochemical investigations were performed on parayn-embedded 3 μm sections using peroxidase-conjugated, aynity-isolated immunoglobulins. All sections were routinely stained with haematoxylin and eosine (H&E) and were processed in parallel to reduce internal staining variations. Measuring collagen type I/III ratio by cross polarisation microscopy For cross polarisation microscopy (CPM), 5 μm sections were stained in Picrosirius solution (0.1% solution of Sirius Red F3BA in saturated aqueous picric acid, ph 2) according to Junqueira for 1 h [15]. The sections were washed in 0.01 N HCl for 2 min and then were dehydrated, cleared and mounted in synthetic resin. To analyse collagen type I/III ratios, tissue samples were evaluated using CPM. Thicker collagen type-i Wbres were stained red orange, whereas thinner collagen type-iii Wbres were stained pale green. For each sample, pictures of ten sections (400 ; area 100 μm 100 μm) within the mesh to host interface were captured by a digital camera (Olympus C-3030, Hamburg, Germany). Ratios of collagen type I/III were assessed by analysing the relative areas of collagen type-i and type- III using digital image-analysing software (Image-Pro Plus 4.5, Media Cybernetics, Silver Spring, MD). Statistical analysis Statistical analysis was carried out using the Statistical Package for Social Sciences software (SPSS, Vers.17.0, Chicago, IL). Data of mesh width, mesh length, tensiometry (power to extract the mesh) and ratio of collagen type I/III were organised according to study group. DiVerences between the groups were evaluated for statistical signiwcance by Kruskal Wallis test, and, in the case of signiwcant diverences, groups were compared by the non parametric Mann-Whitney post-hoc test. P-values < 0.05 were considered signiwcant. Data are presented as mean values standard deviation unless otherwise stated. Results The day after the surgical intervention, all animals returned to normal activity. In two animals of group 1, a subcutaneous wound infection was observed that could be managed by conservative treatment. Mesh size Before excision of the abdominal wall, the position of the mesh was assessed by laparotomy and direct observation. Neither mesh dislocation nor migration was observed. In all groups, mesh width ranged from 10 cm up to 12 cm, and mesh length was measured at between 14 and 16.7 cm. In groups 1 and 4, the width of the mesh decreased insigniwcantly from 12 cm on postoperative day 7, to 10 cm on postoperative day 56 (Mann Whitney post-hoc test, each P > 0.1). In both groups, the length of the mesh size did not decrease over time. In summary, the values of mesh width and mesh length changed, but with no signiwcant diverences between diverent groups and diverent time points (Table 1). Tensiometry A 5 cm wide mesh band was extracted as described above. In 48 out of 72 attempts, it was not possible to extract the mesh completely from the abdominal wall, due to splitting of the mesh because it was already strongly incorporated into the abdominal wall. Already after 7 days, in 14 out of 24 measurements the mesh was split by tensiometry. The minimum force needed to tear out the mesh was 159 N and the maximum force was 200 N. The force required to extract the mesh increased only minimally with implantation time. Only in group 1 did the results of tensiometry reveal a minimal lowered force on day 14 (Kruskal Wallis test, P = 0.03). Indeed, in all measurements of group 1 the mesh was split by tensiometry on day 14. Control Mann Whitney post-hoc tests revealed no signiwcant diverences between group 1 and all other groups (P >0.1). Likewise, no signiwcant diverences between time intervals and diverent Wxation techniques of the mesh were seen in any of the other groups (all P > 0.05; Table 1). Table 1 Results of mesh sizing and mechanical investigations presented as mean standard deviation Mesh width (cm) Mesh length (cm) Tensiometry force (N) Without Wxation Vicryl Prolene Quixil

4 626 Hernia (2010) 14: Fig. 1 Box plots demonstrating the collagen type I/III ratio. There were no signiwcant diverences between groups (P <0.05) Histological assessment Collagen type I/III ratio The ratio of collagen type I/III increased in all groups from day 7 up to day 56. Investigating the ratio of collagen type I/III revealed no signiwcant diverences when comparing the groups on postoperative days 7, 14, and 56, respectively (Kruskal Wallis test: day 7: P = 0.103; day 14: P = 0.168; day: 56 P = 0.570) (Fig. 1). Discussion Mesh Wxation should keep the mesh in position in order to avoid hernia recurrence by mesh dislocation or shrinkage. So far, no investigation has demonstrated how much Wxation is necessary in open incisional hernia repair. Mesh manufacturers recommend a tight Wxation either with sutures or with tacks, with a distance of not more than 2 cm between each Wxation. But studies of pain after inguinal hernia repair have proven a direct correlation between Wxation technique and the development of postoperative pain, highlighting the advantages of Wxation with Wbrin sealant [16 19]. For incisional hernia repair, only a few publications, referring mainly to laparoscopic IPOM techniques, state a requirement for long lasting Wxation either by spiral tacks or/and transfascial sutures [20 26]. For mesh Wxation in open incisional hernia repair there seems to be even less information. So far there is no consensus on the amount and technique of Wxation required. The range goes from tight, non-absorbable Wxation sutures to no Wxation at all. The aim of any kind of Wxation is to prevent any mesh dislocation and migration that might allow a recurrence. Whether Wxation has an impact on the degree of mesh shrinkage remains doubtful. In the Weld of the retromuscular mesh augmentation technique for incisional hernia repair, the questions surrounding mesh Wxation have recently shifting in focus, away from recurrence rate towards postoperative pain. Suture Wxation onto the posterior rectus sheath always runs the risk of intestinal injury, in particular below the linea arcuata, where the posterior rectus sheath is mainly peritoneum and preperitoneal fatty tissue. Transfascial Wxation sutures, on the other hand, have the danger of vascular injury to epigastric vessels and also enhanced postoperative pain probably due to suture tension and restriction of muscle movement within its fascia or sheath. Suture Wxation can be a time-consuming procedure depending on the size of mesh, and leads to additional costs. The mesh measurements obtained in this study are limited by the fact that they were performed following explantation of the mesh-bearing abdominal wall. Because of postmortal contraction of the abdominal wall muscles, the results cannot rexect the absolute degree of shrinkage but should be used only to compare changes in mesh size between the diverent groups. However, we found no dislocation in our study, and mesh measurements revealed no signiwcant diverences between the four Wxation groups investigated, suggesting that the type of mesh Wxation has no impact on the degree of mesh area shrinkage. Regarding the tensiometry results, the connection between mesh and host tissue was already stronger than the stability of the mesh in 7 out of 12 cases after 1 week. In particular, in many cases, it was not possible to extract the mesh completely. The force needed to extract the mesh increased in all groups with time; however, without statistical signiwcance. Notably, the group without any Wxation had similar results to the other groups. There are many studies on mesh Wxation in inguinal hernia repair [27]. Ismael et al. and Garg et al. demonstrated that endoscopic inguinal hernia repair is feasible without Wxation [28 31]. The incidence of pain in open inguinal hernia repair with Lichtenstein technique was reduced by glue Wxation [32]. The feasibility of glue Wxation in incisional hernia repair was also shown by Canziani et al. in a group of 40 patients. Beside a low occurrence of postoperative pain they saw no seroma formation in their patients [33]. The ingrowth and integration of mesh prosthesis depends on the amount and quality of the host tissue response. Whereas type I collagen represents mainly mature adult collagen, forming thick Wbers and preserving high tensile strength, type III collagen is considered as immature, young collagen consisting of thin bundles with a decreased tensile strength. A lowered collagen type I/III ratio correlates with impaired wound healing and increased risk of incisional hernia, and rexects the quality of wound

5 Hernia (2010) 14: healing and tissue integration [34 36]. Our study revealed that the kind of mesh Wxation leads to no signiwcant diverence in the ratio of collagen type I/III. Overall, we found no evect of Wxation, whether by suture or by glue, on dislocation or the degree of shrinkage, on distribution of periwlamental collagen quality or on the mechanical strength of mesh integration. Our results in an animal model suggest that any kind of mesh Wxation in retromuscular mesh augmentation can be omitted under the precondition of a closed fascia in front of the mesh. Acknowledgements Financial support for this study was received from Johnson & Johnson Medical GmbH. The authors thank Mrs. Ellen Krott for her assistance and technical support. References 1. Conze J, Klinge U, Schumpelick V (2005) Incisional hernia. Chirurg 76(9): Burger JW, Luijendijk RW, Hop WC et al (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. 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