René H. Fortelny

Fibrin sealant (Tissucol) enhances tissue integration of condensed polytetrafluoroethylene meshes and reduces early adhesion formation in experimental intraabdominal peritoneal onlay mesh repair.

BACKGROUND The laparoscopic intraabdominal peritoneal onlay mesh repair (IPOM) is a common technique for the reinforcement of multiple ventral hernias or defined defects after laparotomies. However, the placement of synthetic meshes in the intraabdominal cavity can be associated with severe complications. Adhesions frequently originate from the implant and protruding parts of fixation devices, presenting a serious clinical problem with potentially detrimental consequences. This study was designed to assess the impact of fibrin sealing with Tissucol (FS; Baxter, Vienna, Austria) on adhesion formation to condensed polytetrafluoroethylene meshes (Motif Meshes, MM; Proxy Biomedical, Galway, Ireland) as well as on tissue integration of these implants in experimental IPOM repair in rats. It was tested whether FS application allowed the reduction of sutures for mesh fixation without increasing the risk of mesh dislocation. MATERIALS AND METHODS Sixteen rats were assigned to the implantation of MM with four nonresorbable sutures (Synthofil; Ethicon, Norderstedt, Germany) with additional fibrin coating with 0.2 mL FS or to MM fixation with six nonresorbable sutures without FS (n = 8 per group). MM with 2 cm in diameter were implanted in open IPOM by a laparatomy. The observation period of 17 days ensured assessment of adhesions after the full degradation of FS. Adhesions were rated with the score suggested by Vandendael. Histology was performed. RESULTS All eight MMs without FS sealing elicited severe (grade III) adhesions, whereas fibrin-sealed MM were rated mild in 1, moderate in 5, and severe in 2 cases. The superior finding in the FS group was statistically significant. Impaired integration of sutured-only MM was observed in four cases, whereas all FS-sealed MM were well integrated. CONCLUSIONS FS improves the tissue integration, reduces early adhesion formation to cPTFE implants, and allows reduction of perforating fixation devices in experimental IPOM repair.

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial

BACKGROUND Incisional hernia is a frequent long-term complication after abdominal surgery, with a prevalence greater than 30% in high-risk groups. The aim of the PRIMA trial was to evaluate the effectiveness of mesh reinforcement in high-risk patients, to prevent incisional hernia. METHODS We did a multicentre, double-blind, randomised controlled trial at 11 hospitals in Austria, Germany, and the Netherlands. We included patients aged 18 years or older who were undergoing elective midline laparotomy and had either an abdominal aortic aneurysm or a body-mass index (BMI) of 27 kg/m2 or higher. We randomly assigned participants using a computer-generated randomisation sequence to one of three treatment groups: primary suture; onlay mesh reinforcement; or sublay mesh reinforcement. The primary endpoint was incidence of incisional hernia during 2 years of follow-up, analysed by intention to treat. Adjusted odds ratios (ORs) were estimated by logistic regression. This trial is registered at ClinicalTrials.gov, number NCT00761475. FINDINGS Between March, 2009, and December, 2012, 498 patients were enrolled to the study, of whom 18 were excluded before randomisation. Therefore, we included 480 patients in the primary analysis: 107 were assigned primary suture only, 188 were allocated onlay mesh reinforcement, and 185 were assigned sublay mesh reinforcement. 92 patients were identified with an incisional hernia, 33 (30%) who were allocated primary suture only, 25 (13%) who were assigned onlay mesh reinforcement, and 34 (18%) who were assigned sublay mesh reinforcement (onlay mesh reinforcement vs primary suture, OR 0·37, 95% CI 0·20-0·69; p=0·0016; sublay mesh reinforcement vs primary suture, 0·55, 0·30-1·00; p=0·05). Seromas were more frequent in patients allocated onlay mesh reinforcement (34 of 188) than in those assigned primary suture (five of 107; p=0·002) or sublay mesh reinforcement (13 of 185; p=0·002). The incidence of wound infection did not differ between treatment groups (14 of 107 primary suture; 25 of 188 onlay mesh reinforcement; and 19 of 185 sublay mesh reinforcement). INTERPRETATION A significant reduction in incidence of incisional hernia was achieved with onlay mesh reinforcement compared with sublay mesh reinforcement and primary suture only. Onlay mesh reinforcement has the potential to become the standard treatment for high-risk patients undergoing midline laparotomy. FUNDING Baxter; B Braun Surgical SA.

Prevention of Incisional Hernias with Biological Mesh: A Systematic Review of the Literature

Background Prophylactic mesh-augmented reinforcement during closure of abdominal wall incisions has been proposed in patients with increased risk for development of incisional hernias (IHs). As part of the BioMesh consensus project, a systematic literature review has been performed to detect those studies where MAR was performed with a non-permanent absorbable mesh (biological or biosynthetic). Methods A computerized search was performed within 12 databases (Embase, Medline, Web-of-Science, Scopus, Cochrane, CINAHL, Pubmed publisher, Lilacs, Scielo, ScienceDirect, ProQuest, Google Scholar) with appropriate search terms. Qualitative evaluation was performed using the MINORS score for cohort studies and the Jadad score for randomized clinical trials (RCTs). Results For midline laparotomy incisions and stoma reversal wounds, two RCTs, two case–control studies, and two case series were identified. The studies were very heterogeneous in terms of mesh configuration (cross linked versus non-cross linked), mesh position (intraperitoneal versus retro-muscular versus onlay), surgical indication (gastric bypass versus aortic aneurysm), outcome results (effective versus non-effective). After qualitative assessment, we have to conclude that the level of evidence on the efficacy and safety of biological meshes for prevention of IHs is very low. No comparative studies were found comparing biological mesh with synthetic non-absorbable meshes for the prevention of IHs. Conclusion There is no evidence supporting the use of non-permanent absorbable mesh (biological or biosynthetic) for prevention of IHs when closing a laparotomy in high-risk patients or in stoma reversal wounds. There is no evidence that a non-permanent absorbable mesh should be preferred to synthetic non-absorbable mesh, both in clean or clean-contaminated surgery.

Assessment of Pain and Quality of Life in Lichtenstein Hernia Repair Using a New Monofilament PTFE Mesh: Comparison of Suture vs. Fibrin-Sealant Mesh Fixation.

Background: Inguinal hernia repair is one of the most common operations in general surgery. The Lichtenstein tension-free operation has become the gold standard in open inguinal hernia repair. Despite the low recurrence rates, pain and discomfort remain a problem for a large number of patients. The aim of this study was to compare suture fixation vs. fibrin sealing by using a new monofilament PTFE mesh, i.e., the Infinit® mesh by W. L. Gore & Associates. Methods: This study was designed as a controlled prospective single-center two-cohort study. A total of 38 patients were enrolled and operated in Lichtenstein technique either standard suture mesh fixation or fibrin-sealant mesh fixation were used as described in the TIMELI trial. Primary outcome parameters were postoperative complications with the new mesh (i.e., seroma, infection), pain, and quality of life evaluated by the VAS and the SF-36 questionnaire. Secondary outcome was recurrence assessed by ultrasound and physical examination. Follow-up time was 1 year. Results: Significantly, less postoperative pain was reported in the fibrin-sealant group compared to the suture group at 6 weeks (P = 0.035), 6 months (P = 0.023), and 1 year (P = 0.011) postoperatively. Additionally, trends toward a higher postoperative quality of life, a faster surgical procedure, and a shorter hospital stay were seen in the fibrin-sealant group. Conclusion: Fibrin-sealant mesh fixation in Lichtenstein hernioplasty effectively reduces acute and chronic postoperative pain. Monofilament, macro-porous, knitted PTFE meshes seem to be a practicable alternative to commonly used polypropylene meshes in open inguinal hernia repair.

Fibrin sealant (Tissucol) for the fixation of hiatal mesh in the repair of giant paraesophageal hernia: a case report.

Introduction The use of hiatal meshes for the repair of giant paraesophageal hernias (GPH) is associated with a significantly decreased rate of recurrences compared with mesh free techniques. Many surgeons refrain from mesh implantation at the gastroesophageal junction owing to reported complications, such as mesh migration, strictures, and risks of tack or suture placement. This case report presents the laparoscopic application of a titanium-coated mesh (TiSure, GfE, Germany) designated for hiatal repair, with fibrin sealant fixation (Tissucol, Baxter, Austria) in a patient with GPH. Methods A patient (male, 59 y) presented at our outpatient department with a 3-year history of epigastric pain and decreasing lung capacity. A GPH with an intrathoracic upside-down stomach had already been radiologically diagnosed 3 years before admission. In elective laparoscopy, the stomach was repositioned and the crura of the diaphragm were approximated with nonresorbable sutures. The defect was reinforced with a preshaped titanium-coated mesh and fibrin sealant (2 mL) applied with a 45 degree angled tip laparoscopic spraying device. No perforating fixation device was used for mesh fixation itself. The patient was discharged on the seventeenth postoperative (postOP) day. The clinical follow-up included the assessment of postOP pain with a visual analog score and a confirmative computed tomography scan 6 months after surgery. Results The patient has fully recovered, showing no recurrence or adverse effects 1 year postOP. Discussion Based on previous good results from own experimental trials, the mesh sealing approach in hiatal hernia repair was performed clinically, yielding an excellent result in this case. Multicenter trials to assess the full impact of FS mesh fixation in combination with macroporous hiatal meshes seem mandatory.

The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes

Objective: To assess the role of registries in the postmarketing surveillance of surgical meshes. Background: To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries—Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry. Methods: The present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834). Results: Patients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P < 0.001). In the multivariable analysis, the recurrence rate was highly significantly influenced by the mesh type used (P < 0.001). If Physiomesh was used, that led to a highly significant increase in the recurrence rate on 1-year follow-up (odds ratio 2.570, 95% CI 2.057, 3.210). The mesh type used also had a significant influence on chronic pain rates. Conclusions: The importance of real-world data for postmarketing surveillance of surgical meshes has been demonstrated in this registry-based study. Randomized controlled trials are needed for premarket approval of new devices. The role of sponsorship of device studies by the manufacturing company must be taken into account.

Prevention of a Parastomal Hernia by Biological Mesh Reinforcement.

Introduction In the field of hernia prevention, the prophylactic mesh-reinforcement of stoma-sites is one of the most controversially discussed issues. The incidence of parastomal hernias in the literature reported to be up to 48.1% after end colostomy and up to 30.8% after loop of colostomy, but still remains uncertain due to diagnostic variety of clinical or radiological methods, heterogeneous patient groups and variable follow-up intervals. Anyway, the published data regarding the use of synthetic or bio-prostethic meshes in the prevention of parastomal hernia at the primary operation are very scarce. Methods A literature search of the Medline database in terms of biological prophylactic mesh implantation in stoma creation identified six systematic reviews, two randomized controlled trials (RCT), two case-controlled studies, and one technical report. Results In a systematic review focusing on the prevention of parastomal hernia including only RCTs encompassing one RCT using bio-prosthetic mesh the incidence of herniation was 12.5% compared to 53% in the control group (p < 0.0001). In one RCT and two case-control studies, respectively, there was a significant smaller incidence of parastomal herniation as well as a similar complication rate compared to the control group. Only in one RCT, no significant difference regarding the incidence of parastomal hernia was reported with comparable complication rates. Conclusion Thus, so far two RCT and two case-control studies are published with prophylactic bio-prosthetic reinforcement in stoma sites. The majority revealed significant better results in terms of parastomal herniation and without any mesh-related complications in comparison to the non mesh group. Further, multicenter RCT are required to achieve a sufficient level of recommendation.

Use of porcine small intestine submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow up assessment; Surg Endosc (2008) 22: 1941-1946.

To the Editor: We sincerely congratulate Jorge Trevino and colleagues for publishing one of the largest clinical trials on hernia repair using small intestine submucosa (SIS). We especially welcome their effort to present long-term data for various applications of SIS. However, we need to comment and ask for clarification of remaining uncertainties. 1. In the second sentence of their introduction, the authors write that an ideal material for abdominal wall repair should not induce an inflammatory response, a foreign body reaction, or allergic reactions, nor induce hypersensitivity, and they later present SIS as an example. As Franklin Jr. et al. [1] is most likely aware, the study group of Catena et al. has reported formation of a specific antibody to SIS in humans [2]. This phenomenon, practically unknown with synthetic implants, could be interpreted as the induction of an allergic reaction and hypersensitivity to SIS. We kindly ask Franklin Jr et al. to comment on this issue. 2. The authors compare SIS susceptibility to implant infection with extended tetrafluoropolyethylene (ePTFE) based on a study published by Badylak et al. [3] in 1994. We make two remarks. First, Mr. Badylak, one of the key researchers in the development of SIS, has worked as consultant for Cook (www.cooksis.com/technology, www.cookbiotech.com/sci/ref2). This is an important fact that should have been made known to the readers. Second, ePTFE has been abandoned for the described reason by many surgeons in the past 15 years, and a great body of recent literature exists on this issue that is missing in this work [4–6]. 3. Franklin Jr et al. report that the follow-up evaluation was performed during office visits and in some cases by telephone. We are interested in knowing how many cases were followed up by telephone. It seems unlikely that patients can make reliable statements on hernia recurrences or other adverse effects in this manner considering published experiences from surgical research [7]. 4. Why have inguinal hernias been treated using the intraperitoneal onlay mesh (IPOM) technique? We ask Franklin Jr et al. whether they consider this technique as the new standard for the treatment of inguinal hernias using biomeshes. 5. The authors report that an overlap of 3 cm was ensured in all procedures. In this context, it seems mandatory to provide the reader with the actual sizes of the hernia defects. We argue that a 3-cm overlap might not be sufficient in the repair of large ventral hernias. There is strong evidence that SIS shrinks more than synthetic materials [8, 9]. 6. In the Results section, it is noted that 30.8% of all patients included in this study underwent surgery in an urgent setting. However, all procedures had to be performed in an infected or grossly infected field. We are interested in knowing why the rate of clean or clean/contaminated wound fields was zero even for the patients who obviously underwent elective surgery. 7. Franklin Jr et al. report that hernia repair was performed in appendectomies, biliary procedures, and operations for colorectal cancer or noncomplicated and complicated diverticular disease. We ask whether this straightforward regimen is supported by the guidelines on hernia repair in the United States. Based on the recommendations of surgical societies in Europe, malignant diseases or complicated A. H. Petter-Puchner (&) R. H. Fortelny Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Hernia Research, Wien, Austria e-mail: alexander.petter@lbitrauma.org

Spray application of fibrin sealant with an angled spray tip device in laparoscopic inguinal hernia repair

ZusammenfassungGRUNDLAGEN: Die Art der Fibrinkleber (FS)-Applikation trägt wesentlich zu den Vorzügen dieser Methode, um Herniennetze zu fixieren, bei. Obwohl in zahlreichen Studien belegt werden konnte, dass die punktförmige Applikation von FS ausreichende Festigkeiten und Elastizität gewährleistet, erschien die Sprayapplikation von FS als wesentliche Verbesserung. Diese Studie sollte die Sicherheit und den Anwendungskomfort eines neuartigen FS-Spraysystems mit abgewinkeltem Sprühkopf in einer 1-jährigen klinischen Anwendungsbeobachtung testen. METHODIK: Nachdem die schriftliche Zustimmung eingeholt wurde, wurden bei 27 Patienten 33 primäre Leistenhernien in TAPP-Technik versorgt. Das makroporöse TiMesh (GfE, Deutschland) wurde mit 2 ml FS (Tissucol®) mittels eines neuartigen Spraysystems mit abgewinkeltem Sprühkopf fixiert. Der Sprühkatheter kann über einen 5 mm-Trokar eingeführt werden und verfügt über eine separate CO2-Zufuhr. Der Beobachtungszeitraum war 1 Jahr. ERGEBNISSE: Die Bedienung des Spraysystems war einfach und ergonomisch zufriedenstellend, und es wurden keine Komplikationen im Zusammenhang mit dessen Anwendung beobachtet. Der Sprühkegel des FS war gut sichtbar, und es wurden keine Serome gefunden. Die Patienten entwickelten keinen chronischen Schmerz, und es kam innerhalb des einen Jahres zu keinem Rezidiv. 2 ml für unilaterale bzw. 4 ml FS für bilaterale Hernien waren ausreichend. SCHLUSSFOLGERUNGEN: Das neuartige Spraysystem mit abgewinkeltem Sprühkopf stellt eine klare Verbesserung gegenüber den bisher erhältlichen Fixationsmethoden dar. Die Anwendung ist einfach und ermöglicht eine erhebliche Reduktion der zur Netzfixation notwendigen FS-Menge. Eine Reduktion der Rate der Serome sowie eine Kostensenkung erscheinen so möglich.SummaryBACKGROUND: The method of fibrin sealant (FS) application for hernia mesh fixation is essential to obtain its full benefits and advantages (i.e., the reduction of chronic pain). In several studies on hernioplasty, punctual mesh fixation with FS proved to be efficient in terms of fixation strength and elasticity and it was hypothesized that an angled tip laparoscopic spray system (LSS) would improve and facilitate the application of the sealant. The aim of the study was to examine the safety and handling of LSS as well as the one-year outcome. METHODS: After informed written consent was obtained, transabdominal preperitoneal hernioplasty (TAPP) was performed in 33 primary inguinal hernias in 27 non-selected consecutive patients by a single surgeon. A macroporous mesh (TI-Mesh®, GfE, Germany) was fixed with 2 ml of FS composed of 1 ml of fibrinogen and 1 ml of thrombin (Tisseel® = Tissucol®). The FS was applied using a newly developed angled spray catheter insertable through a 5 mm trocar and attached to a CO2 regulator device. Patients were followed up for one year. RESULTS: The angled tip allowed targeted distribution of FS by minimal movements of the device and was safe. The spray cone was always clearly visible during application. At 3 and 12 months no seromas were detectable. VAS score decreased corresponding to the absence of chronic pain and no recurrences occurred. Two milliliter FS for uni- and 4 ml for bilateral hernia meshes were sufficient. CONCLUSIONS: This new angled tip LSS provides excellent handling for an atraumatic broad fixation of mesh in the TAPP-hernioplasty, avoiding late seroma and recurrence despite a substantial reduction of the amount of FS required. It could therefore also help to save costs.

Open and Laparo-Endoscopic Repair of Incarcerated Abdominal Wall Hernias by the Use of Biological and Biosynthetic Meshes

Introduction Although recently published guidelines recommend against the use of synthetic non-absorbable materials in cases of potentially contaminated or contaminated surgical fields due to the increased risk of infection (1, 2), the use of bio-prosthetic meshes for abdominal wall or ventral hernia repair is still controversially discussed in such cases. Bio-prosthetic meshes have been recommended due to less susceptibility for infection and the decreased risk of subsequent mesh explantation. The purpose of this review is to elucidate if there are any indications for the use of biological and biosynthetic meshes in incarcerated abdominal wall hernias based on the recently published literature. Methods A literature search of the Medline database using the PubMed search engine, using the keywords returned 486 articles up to June 2015. The full text of 486 articles was assessed and 13 relevant papers were identified including 5 retrospective case cohort studies, 2 case-controlled studies, and 6 case series. Results The results of Franklin et al. (3–5) included the highest number of biological mesh repairs (Surgisis®) by laparoscopic IPOM in infected fields, which demonstrated a very low incidence of infection and recurrence (0.7 and 5.2%). Han et al. (6) reported in his retrospective study, the highest number of treated patients due to incarcerated hernias by open approach using acellular dermal matrix (ADM®) with very low rate of infection as well as recurrences (1.6 and 15.9%). Both studies achieved acceptable outcome in a follow-up of at least 3.5 years compared to the use of synthetic mesh in this high-risk population (7). Conclusion Currently, there is a very limited evidence for the use of biological and biosynthetic meshes in strangulated hernias in either open or laparo-endoscopic repair. Finally, there is an urgent need to start with randomized controlled comparative trials as well as to support registries with data to achieve more knowledge for tailored indication for the use of biological meshes.