Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial.

BACKGROUND: Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material. METHODS: A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome. RESULTS: The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173). CONCLUSION: The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov).

Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies.

BACKGROUND: Incisional hernia is a frequent complication of abdominal wall incision. Surgical technique is an important risk factor for the development of incisional hernia. The aim of these updated guidelines was to provide recommendations to decrease the incidence of incisional hernia. METHODS: A systematic literature search of MEDLINE, Embase, and Cochrane CENTRAL was performed on 22 January 2022. The Scottish Intercollegiate Guidelines Network instrument was used to evaluate systematic reviews and meta-analyses, RCTs, and cohort studies. The GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation) was used to appraise the certainty of the evidence. The guidelines group consisted of surgical specialists, a biomedical information specialist, certified guideline methodologist, and patient representative. RESULTS: Thirty-nine papers were included covering seven key questions, and weak recommendations were made for all of these. Laparoscopic surgery and non-midline incisions are suggested to be preferred when safe and feasible. In laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus. For closure of an elective midline laparotomy, a continuous small-bites suturing technique with a slowly absorbable suture is suggested. Prophylactic mesh augmentation after elective midline laparotomy can be considered to reduce the risk of incisional hernia; a permanent synthetic mesh in either the onlay or retromuscular position is advised. CONCLUSION: These updated guidelines may help surgeons in selecting the optimal approach and location of abdominal wall incisions.

An incisional hernia results from a weakness of the abdominal wall muscles that allows fat from the inside or organs to bulge out. These hernias are quite common after abdominal surgery at the site of a previous incision. There is research that discusses different ways to close an incision and this may relate to the chance of hernia formation. The aim of this study was to review the latest research and to provide a guide for surgeons on how best to close incisions to decrease hernia rates. When possible, surgery through small incisions may decrease the risk of hernia formation. If small incisions are used, it may be better if they are placed away from areas that are already weak (such as the belly button). If the incision is larger than 1 cm, it should be closed with a deep muscle-fascia suture in addition to skin sutures. If there is a large incision in the middle of the abdomen, the muscle should be sutured using small stitches that are close together and a slowly absorbable suture should be used. For patients who are at higher risk of developing hernias, when closing the incision, the muscle layer can be strengthened by using a piece of (synthetic) mesh. There is no good research available on recovery after surgery and no clear guides on activity level or whether a binder will help prevent hernia formation.

Small and Laterally Placed Incisional Hernias Can be Safely Managed with an Onlay Repair.

INTRODUCTION: In meta-analyses and systematic reviews, clear advantages have been identified for the sublay versus onlay technique for treatment of incisional hernias. Nonetheless, an expert panel has noted that the onlay mesh location may be useful in certain settings. MATERIALS AND METHODS: First, unadjusted analysis of data from the Herniamed Registry was performed to compare 6797 sublay operations with 1024 onlay operations for repair of incisional hernias. Then, using propensity score matching to account for the influence of variables age, gender, ASA score, BMI, risk factors, preoperative pain, defect size, and defect localization, 1016 pairs were formed and compared with each other. RESULTS: Unadjusted analysis revealed that the onlay operation was used significantly more often for small defects, lateral defect localization, and in women. After comparing the propensity score-matched pairs, no significant difference was found between the sublay and onlay technique in the outcome criteria intra- and postoperative complications, general complications, complication-related reoperations, pain at rest, pain on exertion, chronic pain requiring treatment, and recurrence on 1-year follow-up. But that was true only for this carefully selected patient collective. CONCLUSION: In a selected patient collective with small and lateral incisional hernias and with a large proportion of women, outcomes obtained for the onlay and sublay techniques do not differ significantly.

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.

Self-Gripping Meshes for Lichtenstein Repair. Do We Need Additional Suture Fixation?

BACKGROUND: The Lichtenstein repair is a frequently used treatment of inguinal hernias. In recent years, there has been an increasing tendency to apply self-gripping meshes (s.g). In many cases, additional suture of the mesh is carried out; however, it is uncertain what the benefits or potential risks of this actually are. METHODS: The evaluation was undertaken on the basis of the Herniamed register, and covered all unilateral Lichtenstein operations between 01.09.2009 up to 30.09.2013. The analysis only included patients with whom s.g. meshes with resorbable micro hooks had been used (Progrip(®), Covidien) and who had undergone a full 1-year follow-up examination (80.15 %). RESULTS: In total, 2095 patients were suitable for analysis, of which 816 (38.95 %) cases received an additional suture fixation (Fix). With increasing hernia size, more frequent fixation took place (29.97 % of hernias <1.5 cm vs. 46.65 % of hernias >3 cm, p < 0.001). The recurrence rates 1 year after surgery did not show any significant differences (Fix. 0.86 % vs. No Fix. 1.17 %; p = 0.661) with and without fixation, even when being adjusted for covariables. Likewise, no differences were noted in terms of postoperative complications (Fix. 5.15 % vs. No Fix. 5.08 %; p = 1.0). In addition, the numbers of patients needing to be treated after 1 year for chronic pain were also comparable (Fix. 2.33 % vs. No Fix. 2.97 %; p = 0.411). CONCLUSION: Within the group that did not have additional suture fixation of self-gripping meshes (No Fix.), the length of operations was on average 8 min shorter (p < 0.001). No differences could be observed in terms of postoperative complications, treatment requiring chronic pain and recurrence rates.

Delayed closure of open abdomen in septic patients is facilitated by combined negative pressure wound therapy and dynamic fascial suture.

INTRODUCTION: The aim of this prospective controlled trial was the definition of the optimal timepoint for delayed closure after negative pressure wound therapy (NPWT) in the treatment of the open abdomen (OA) in septic patients after abdominal surgery. The delayed closure of the abdominal wall after abdominal NPWT treatment is often problematic due to the lateralization of the fascial edge leading to unfavorably high tensile forces of the adapting sutures in the midline. We present the results of an innovative combination of NPWT with a new fascial-approximation technique using dynamic fascial sutures (DFS) and delayed closure of the abdominal wall. METHODS: Eighty-seven patients subjected to OA therapy following surgery for secondary peritonitis were treated with NPWT and DFS. In all patients, a running suture of elastic vessel loops was used to approximate fascial edges. This procedure was continued for the duration of NPWT until final closure of the abdomen with running suture in 55 patients (63.2 %) and interrupted suture technique in eight patients (9.2 %). An anterior component separation was performed in seven patients. RESULTS: Delayed closure was achieved in 68 patients (78.2 %) after 12.6 days [mean (SD) 25.1 (2-204)] days and 4.3 re-operations [mean (SD) 6.0 (1-43)]. Fifteen (17.2 %) superficial and two (2.3 %) deep wound infections occurred. In three (3.4 %) cases, entero-atmospheric fistulas had to be treated. We recorded no technique-specific complications. Four (5.9 %) incisional hernia were detected in a mean follow-up of 40.5 months (16-65). Mortality rate was 55.2 %. CONCLUSION: Using a new technique combining NPWT and DFS in the treatment of the OA, the delayed closure of the fascial edges by running suture can be achieved and the number of re-operations can be kept low. The technique was safe and led to a low incidence of incisional hernias. Extensive abdominal wall reconstruction was seldom required.

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial.

Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.

Transporous hernia mesh fixation with fibrin sealant in an in vitro model of spray application.

BACKGROUND: The spray application of fibrin sealant (FS) is widely used for atraumatic mesh fixation in open and laparoscopic hernia surgery. Studies focusing on the optimization of sealant distribution are rare. This study elucidates the impact of spray distance and pressure, the thrombin concentration of the FS, as well as the mesh design on the spray process and the resulting sealant distribution. Furthermore, the effect of interrupting the spray process on sealant distribution was investigated. MATERIAL AND METHODS: Three different meshes were sprayed in a vertical test arrangement with 0.4 mL FS. Fibrin sealants containing 4 and 500 IU/mL thrombin (Tisseel and Artiss; Vienna, Austria) provided by Baxter Biosciences were used. The application distances varied from 5 to 8 cm. The relative fibrin sealant distribution on the individual mesh surfaces was evaluated and compared, as well as loss of FS and patterns of clot formation. RESULTS: Spray distances between 5 and 8 cm led to a homogenous sealant distribution. Lower thrombin concentrations led to significant losses of FS due to slower polymerization. Differences of the fibrin sealant distribution and mesh pore sizes were found. No differences between continuous and discontinuous application were observed. CONCLUSION: The spray application of FS provides a uniform sealant film in a defined range of distances. However, design and pore size of different meshes substantially impact sealant distribution. These findings should be considered when selecting prosthesis for hernia repair. In general, the amount of sealant should not exceed 0.08 mL per cm(2) to avoid obstruction of mesh pores.

Use of fibrin sealant (Tisseel/Tissucol) in hernia repair: a systematic review.

BACKGROUND: Abdominal wall and inguinal hernia repair are the most frequently performed surgical procedures in the United States and Europe. However, traditional methods of mesh fixation are associated with a number of problems including substantial risks of recurrence and of postoperative and chronic pain. The aim of this systematic review is to summarize the clinical safety and efficacy of Tisseel/Tissucol fibrin sealant for hernia mesh fixation. METHODS: A PubMed title/abstract search was conducted using the following terms: (fibrin glue OR fibrin sealant OR Tisseel OR Tissucol) AND hernia repair. The bibliographies of the publications identified in the search were reviewed for additional references. RESULTS: There were 36 Tisseel/Tissucol studies included in this review involving 5,993 patients undergoing surgery for hernia. In open repair of inguinal hernias, Tisseel compared favorably with traditional methods of mesh fixation, being associated with shorter operative times and hospital stays and a lower incidence of chronic pain. Similarly, after laparoscopic/endoscopic inguinal hernia repair, Tisseel/Tissucol was associated with less use of postoperative analgesics and less acute and chronic postoperative pain than tissue-penetrating mesh-fixation methods. Other end points of concern to surgeons and patients are the risks of inguinal hernia recurrence and of complications such as hematoma formation and intraoperative bleeding. Comparative studies show that Tisseel/Tissucol does not increase the risk of these outcomes and may, in fact, decrease the risk compared with tissue-penetrating fixation methods. When used in the repair of incisional hernias, Tisseel/Tissucol significantly decreased both postoperative morbidity and duration of hospital stay. CONCLUSIONS: Clinical evidence published to date supports the use of Tisseel/Tissucol as an option for mesh fixation in open and laparoscopic/endoscopic repair of inguinal and incisional hernias. Guidelines of the International Endohernia Society recommend fibrin sealant mesh fixation, especially in inguinal hernia repair. Nonfixation is reserved for selected cases.

The Best Closure Technique Without Mesh in Elective Midline Laparotomy Closure.

Introduction: The risk of developing an incisional hernia after primary elective median laparotomy is reported in the literature as being between 5 and 20 percent. The basic of an optimal outcome after midline incision is the appropriate closure technique with or without a prophylactic mesh. The objective of this paper is to critically examine the various closure techniques and, in particular, to present a detailed comparison of the long stitch and short stitch techniques. Method: Based on the available literature, the characteristics of the different closure techniques are described in detail, advantages and disadvantages are compared, and the current status of a practicable recommendation is discussed. Special attention is paid to the criteria of the short stitch technique, such as the suture to incision length ratio, number of stitches and distances, as well as suture material. Results: For elective midline closures, the use of a continuous closure using a slowly absorbable suture material in the small-bites technique with suture to wound ratio of at least 5:1 result in significantly lower risk of complications such as bursting abdomen and less incisional hernia rates compared to the large-bites technique. Conclusion: Based on the present evidence in midline closure after elective laparotomy the small bites technique can be recommended to significantly reduce the rate of incisional hernia.

[Intraoperative fascial traction (IFT) for treatment of large ventral hernias : A retrospective analysis of 50 cases]. / Intraoperative Faszientraktion (IFT) zur Behandlung großer ventraler Hernien : Eine retrospektive Analyse von 50 Fällen.

OBJECTIVE: The aim was to evaluate the effectiveness, clinical practicability, and complication rate of the intraoperative fascial traction (IFT) procedure for the treatment of large ventral hernias. METHOD: This study evaluated 50 patients from 11 specialized centers with an intraoperatively measured fascial distance of more than 8 cm, who were treated by IFT (traction time 30-35 min) using the fasciotens® hernia traction procedure. RESULTS: Fascial gaps measured preoperatively ranged from 8 cm to 44 cm, with most patients (94%) having a fascial gap above 10 cm (W3 according to the European Hernia Society classification). The mean fascial distance was reduced from 16.1 ± 0.8 cm to 5.8 ± 0.7 cm (stretch gain 10.2 ± 0.7 cm, p < 0.0001, Wilcoxon matched-pairs signed-ranks test). A reduction in fascial distance of at least 50% was achieved in three quarters of the patients and in half of the treated patients the reduction in fascial distance amounted to even more than 70%. The closure rate achieved by IFT after a mean surgical duration of 207.3 ± 11.0 min was 90% (45/50). Hernia closure was performed in all cases with a mesh augmentation in a sublay position. Postoperative complications occurred in 6 patients (12%). A reoperation was required in 3 patients (6%). CONCLUSION: The described IFT method is a new procedure for abdominal wall closure in large ventral hernias. The presented results demonstrate a high effectiveness, a good clinical practicability and a low complication rate of IFT.

A comparative biomechanical evaluation of hernia mesh fixation by fibrin sealant.

BACKGROUND: The atraumatic fixation of meshes by fibrin sealant (FS) has been established for both open and laparoscopic techniques of hernia repair. This study was performed to evaluate the use of FS in hernia mesh fixation with different polymerization speed (thrombin concentrations), using commercial hernia meshes, and in two techniques, transabdominal preperitoneal mesh placement (TAPP) and intraperitoneal mesh placement (IPOM). MATERIALS AND METHODS: A median laparotomy was performed in a pig model and hernia meshes were placed in IPOM and TAPP techniques. After mesh fixation with FS using thrombin concentrations of 4 and 500 IU/mL, maximum shear force before failure was measured at 5, 60, and 120 min. RESULTS: At both thrombin concentrations and in all meshes in which the technique was used, the TAPP method tended to show higher maximum force levels at failure than did the IPOM method. In both TAPP and IPOM techniques and in all meshes, the 4 IU/mL thrombin concentration FS was superior to the 500 IU/mL thrombin concentration sealant. CONCLUSIONS: Although both thrombin concentrations are suitable for mesh fixation, lower concentrations allow slower polymerization and better sealant diffusion leading to higher maximum force levels at failure. The TAPP method was biomechanically superior to the IPOM method. There were no major differences between mesh products.

The feasibility of FS mesh fixation by a transgastric approach--an important benefit in future NOTES procedures?

BACKGROUND: Preserving the integrity of the abdominal wall is a major benefit in NOTES procedures. It may result in a decrease of postoperative (postOP) pain, infection, and port site hernia. This experimental study on intra-peritoneal onlay mesh (IPOM) repair was designed to apply meshes by a transgastric access (TGA) and to use a combination of transfascial sutures and fibrin sealant as fixation. MATERIALS AND METHODS: Four abdominal wall defects were created by TGA under laparoscopic control in five nonsurvival and three survival pigs (4, 11, and 22 d observation period). Titanized polypropylene meshes were fixed transfascially by four polypropylene sutures using a "suture passer" device. Meshes were additionally fixed with 0.2 mL of fibrin sealant (FS) by an endoscopic application. TGA was closed with endoclips in the nonsurvival model and with laparoscopic suturing in survival pigs. RESULTS: The three survival pigs were euthanized on the d 4, 11, and 22 postOP. The macroscopic evaluation revealed excellent integration of the meshes without signs of shrinkage, dislocation, or inflammation. Histology confirmed macroscopic findings. CONCLUSIONS: Our findings confirm that IPOM repair of ventral hernia in an experimental NOTES hybrid procedure is feasible. This study also demonstrates the technical feasibility and the potential advantages of FS mesh fixation to further reduce trauma to the abdominal wall following the key principles of the NOTES approach.

Forensic Implications of Anatomical Education and Surgical Training With Cadavers.

Anatomical education and surgical training with cadavers are usually considered an appropriate method of teaching, above all for all surgeons at various levels. Indeed, in such a way they put into practice and exercise a procedure before performing it live, reducing the learning curve in a safe environment and the risks for the patients. Really, up to now it is not clear if the nonuse of the cadavers for anatomical education and surgical training can have also forensic implications. A substantial literature research was used for this review, based on PubMed and Web of Science database. From this review, it is clear that the cadaveric training could be considered mandatory, both for surgeons and for medical students, leading to a series of questions with forensic implications. Indeed, there are many evidences that a cadaver lab can improve the learning curve of a surgeon, above all in the first part of the curve, in which frequent and severe complications are possible. Consequently, a medical responsibility for residents and surgeons which perform a procedure without adequate training could be advised, but also for hospital, that has to guarantee a sufficient training for its surgeons and other specialists through cadaver labs. Surely, this type of training could help to improve the practical skills of surgeons working in small hospitals, where some procedures are rare. Cadaver studies can permit a better evaluation of safety and efficacy of new surgical devices by surgeons, avoiding using patients as ≪guinea pigs≫. Indeed, a legal responsibility for a surgeon and other specialists could exist in the use of a new device without an apparent regulatory oversight. For a good medical practice, the surgeons should communicate to the patient the unsure procedural risks, making sure the patients' full understanding about the novelty of the procedure and that they have used this technique on few, if any, patients before. Cadaver training could represent a shortcut in the standard training process, increasing both the surgeon learning curve and patient confidence. Forensic clinical anatomy can supervise and support all these aspects of the formation and of the use of cadaver training.

Small intestine submucosa (SIS) implants in experimental IPOM repair.

BACKGROUND: Synthetic meshes can cause adverse effects (e.g., adhesions, mesh infection) in intraperitoneal onlay mesh repair (IPOM). Although data for its biocompatibility as well as degradation behavior is still scarce, small intestine submucosa (SIS) implants have been suggested as a favorable alternative for IPOM repair. The aim of the study was to assess safety and efficacy of SIS used as allo- or xenograft in an experimental model of IPOM repair, with the purpose of creating a critical awareness for specific aspects of the biomesh concept among researchers and surgeons alike. Main outcome parameters were adhesion formation, tissue integration, shrinkage, and dislocation. MATERIALS AND METHODS: Open IPOM repair was performed in 16 Sprague Dawley rats and two minipigs. SIS implants were 2 x 2 cm in rats (one per animal) and 6 x 8 cm in pigs (four per animal). All implants were fixed with six nonresorbable sutures. Observation period was 17 and 28 d (n =8) in rats and 28 d in pigs. Outcome parameters were assessed macroscopically, and histologic samples (H and E staining) were obtained. RESULTS: Upon autopsy, SIS appeared to be only moderately integrated. Dislocation of five SIS implants in the rats and of two SIS implants in the pigs were observed although all sutures were still in place. No seroma formation or infection was detected macroscopically, but substantial shrinkage and adhesion formation at the margins of implants and suture sites were frequently observed. Histology confirmed the macroscopic finding of limited integration and substantial shrinkage. The pathomorphology was similar in both species. CONCLUSIONS: Small intestine submucosa implants are susceptible to shrinkage, dislocation, and adhesion formation in experimental IPOM repair in rats and pigs. These findings are in accordance with literature and warrant further investigations of SIS implants in hernia repair.

Fibrin sealant (Tisseel) for hiatal mesh fixation in an experimental model in pigs.

BACKGROUND: This study was designed to assess the efficacy of the fibrin sealant fixation of titanized polypropylene mesh in experimental hiatal mesh closure in pigs. Prosthetic hiatal closure is recommended for the repair of large hiatal/paraesophageal hernias as well as for antireflux surgery. However, only limited data exist on the favorable choice of meshes and fixation devices. Migration of the implant and trauma to neighboring organs due to perforating devices, such as sutures or tacks, present potentially lethal complications. In this study, we propose the fixation of titanized polypropylene meshes (TS) specifically developed for hiatal closure (TISure; GfE Medizintechnik GmbH, Nuremberg, Germany) with human fibrin sealant (FS, Tisseel; Baxter Biosciences, Vienna, Austria). MATERIALS AND METHODS: A laparotomy was carried out in 7 mini-pigs (27-30 kg bodyweight) under general anaesthesia, and a TS was implanted after precise dissection of the right and left crura and the crural commissure. The key hole of the TS was placed around the esophagus at the gastroesophageal junction. One mL of FS was applied with the Easy Spray system (Baxter Biosciences, Vienna, Austria) for circular and three dimensional mesh fixation onto the diaphragm. Due to the lack of accepted gold standards of hiatal mesh reinforcement, no control group was used. Animals were sacrificed after 4 wk, and meshes were explanted after macroscopical assessment of the correct position and tissue integration. Histology was performed. RESULTS: All meshes showed excellent tissue integration and no signs of migration or dislocation. FS was completely degraded and replaced by well vascularized fibroblastic tissue. CONCLUSIONS: Titanized polypropylene mesh with FS fixation was found to be a safe and efficient combination for reinforcement of the hiatal closure in this preliminary experimental model.

Delayed Closure of Open Abdomen in Septic Patients Treated With Negative Pressure Vacuum Therapy and Dynamic Sutures: A 10-Years Follow-Up on Long-Term Complications.

Introduction: Patients with open abdomen after surgical interventions associated with the complication of secondary peritonitis are successfully treated with negative pressure wound therapy. The use of dynamic fascial sutures reduces fascial lateralization and increases successful delayed fascial closure after open abdomen treatment. Methods: In 2017 we published the follow-up results of 38 survivors out of 87 open abdomen patients treated with negative pressure wound therapy and dynamic fascial sutures between 2007 and 2012. In our current study we present the 10-years follow-up results regarding long-term complications with the focus on incisional hernias and pain. Since 2017 seven more patients have died, hence 31 patients were included in the current study. The patients were asked to answer questions about specific long-term complications of OA treatment including pain, the presence of incisional hernias and subsequent surgical interventions. Demographic data and data regarding fascial closure after open abdomen treatment were collected. All results were analyzed quantitatively. The follow-up period was 8-13 years. Results: The median age was 69 (30-90) years, and 15 (48.4%) were females. Twenty-four patients (77.4%) responded to the questionnaire: Three patients (12.5%) suffered from pain in the original operating field, all three at rest but not during exercise. None of the patients required analgesic treatment. Eleven patients (45.8%) were found to have incisional hernias. Five out of 11 hernias (45.5%) were treated by surgery and did not declare any pain in the operating field. Among the patients with incisional hernias lower MPI (Mannheimer Peritonitis Index) at the time of primary surgery but more reoperations and treatment days were found. The technique of fascial closure was heterogenic and no differences in the occurrence of incisional hernia could be detected. Conclusion: The incidence of incisional hernias after open abdomen treatment is still high, but are associated with little pain in the original operating field. Further studies are required to investigate methods for fascial closure techniques after OA treatment.

Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial.

BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair. MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair. RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences. CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.

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.

Abdominal Wall Closure in Elective Midline Laparotomy: The Current Recommendations.

INTRODUCTION: The risk of developing an incisional hernia after primary elective median laparotomy is reported in the literature as being between 5 and 20 percent. The goal of this systematic review was to evaluate different closure techniques for midline laparotomies and the use of additional prophylactic mesh augmentation for midline closure in high risk patients. METHOD: A systematic literature search was performed until September 2017. The quality of the RCTs was evaluated and analysed. The data are reported in accordance with the Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RESULTS: In the systematic review for closure techniques a total of 23 RCTs and 9 RCTs for the use of prophylactic mesh were included. In elective midline closure the use of a slowly absorbable suture material for continuous closure using the small bites technique results in significantly less incisional hernias than a large bites technique (OR 0.41; 95% CI 0.19, 0.86). The use of prophylactic mesh versus the suture closure of the midline achieved a significant reduction of the incisional hernia rate [OR 0.14 (95% CI 0.07-0.27)]. CONCLUSIONS: Based on the currently evidence in midline closure after elective laparotomy in the small bites technique can be recommended to reduce significantly the rate of incisional hernia. The additional use of a prophylactic mesh in high risk patients can significantly reduce the occurrence of incisional hernia.