European Hernia Society guidelines on prevention and treatment of parastomal hernias

Background International guidelines on the prevention and treatment of parastomal hernias are lacking. The European Hernia Society therefore implemented a Clinical Practice Guideline development project. Methods The guidelines development group consisted of general, hernia and colorectal surgeons, a biostatistician and a biologist, from 14 European countries. These guidelines conformed to the AGREE II standards and the GRADE methodology. The databases of MEDLINE, CINAHL, CENTRAL and the gray literature through OpenGrey were searched. Quality assessment was performed using Scottish Intercollegiate Guidelines Network checklists. The guidelines were presented at the 38th European Hernia Society Congress and each key question was evaluated in a consensus voting of congress participants. Results End colostomy is associated with a higher incidence of parastomal hernia, compared to other types of stomas. Clinical examination is necessary for the diagnosis of parastomal hernia, whereas computed tomography scan or ultrasonography may be performed in cases of diagnostic uncertainty. Currently available classifications are not validated; however, we suggest the use of the European Hernia Society classification for uniform research reporting. There is insufficient evidence on the policy of watchful waiting, the route and location of stoma construction, and the size of the aperture. The use of a prophylactic synthetic non-absorbable mesh upon construction of an end colostomy is strongly recommended. No such recommendation can be made for other types of stomas at present. It is strongly recommended to avoid performing a suture repair for elective parastomal hernia. So far, there is no sufficient comparative evidence on specific techniques, open or laparoscopic surgery and specific mesh types. However, a mesh without a hole is suggested in preference to a keyhole mesh when laparoscopic repair is performed. Conclusion An evidence-based approach to the diagnosis and management of parastomal hernias reveals the lack of evidence on several topics, which need to be addressed by multicenter trials. Parastomal hernia prevention using a prophylactic mesh for end colostomies reduces parastomal herniation. Clinical outcomes should be audited and adverse events must be reported.

European Hernia Society guidelines on prevention and treatment of parastomal hernias.

BACKGROUND: International guidelines on the prevention and treatment of parastomal hernias are lacking. The European Hernia Society therefore implemented a Clinical Practice Guideline development project. METHODS: The guidelines development group consisted of general, hernia and colorectal surgeons, a biostatistician and a biologist, from 14 European countries. These guidelines conformed to the AGREE II standards and the GRADE methodology. The databases of MEDLINE, CINAHL, CENTRAL and the gray literature through OpenGrey were searched. Quality assessment was performed using Scottish Intercollegiate Guidelines Network checklists. The guidelines were presented at the 38th European Hernia Society Congress and each key question was evaluated in a consensus voting of congress participants. RESULTS: End colostomy is associated with a higher incidence of parastomal hernia, compared to other types of stomas. Clinical examination is necessary for the diagnosis of parastomal hernia, whereas computed tomography scan or ultrasonography may be performed in cases of diagnostic uncertainty. Currently available classifications are not validated; however, we suggest the use of the European Hernia Society classification for uniform research reporting. There is insufficient evidence on the policy of watchful waiting, the route and location of stoma construction, and the size of the aperture. The use of a prophylactic synthetic non-absorbable mesh upon construction of an end colostomy is strongly recommended. No such recommendation can be made for other types of stomas at present. It is strongly recommended to avoid performing a suture repair for elective parastomal hernia. So far, there is no sufficient comparative evidence on specific techniques, open or laparoscopic surgery and specific mesh types. However, a mesh without a hole is suggested in preference to a keyhole mesh when laparoscopic repair is performed. CONCLUSION: An evidence-based approach to the diagnosis and management of parastomal hernias reveals the lack of evidence on several topics, which need to be addressed by multicenter trials. Parastomal hernia prevention using a prophylactic mesh for end colostomies reduces parastomal herniation. Clinical outcomes should be audited and adverse events must be reported.

Thromboelastographic profile of goat blood after the experimental injury of the femoral artery and use of QuikClot gauze and Celox gauze dressings.

The aim of this study was to evaluate the suitability of thromboelastometry for the analysis of blood test results in goats after the use of hemostatic dressings to control massive bleeding. The study was carried out on 12 goats, 6 animals in each of two subgroups. In all experimental animals incision of the femoral artery was performed, and bleeding was controlled with QuikClot gauze in the first group and Celox gauze in the second group. Dressings were applied for 60 minutes. Blood samples for thromboelastometry were collected from the jugular vein before the incision and 60 min after the application of a dressing. Clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF) and α angle (°) were measured in three standard ROTEM assays (system with generation of reaction curve, numerical parameters and size of the blood clot): intrinsic coagulation pathway (INTEM), extrinsic coagulation pathway (EXTEM) and functional fibrinogen (FIBTEM). Complete hemostasis of the injured femoral artery was found in all goats. No significant differences between pre- and post-incision thromboelastometric parameters were found in any tests in any of the groups, which indicates that the use of dressings was not associated with blood coagulation disorders. This study is the first to describe the use of thromboelastometry in goats for the assessment of clot formation and hemostatic disorders.

Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial sequential analysis.

PURPOSE: Prevention of parastomal hernia (PSH) formation is crucial, given the high prevalence and difficulties in the surgical repair of PSH. To investigate the effect of a preventive mesh in PSH formation after an end colostomy, we aimed to meta-analyze all relevant randomized controlled trials (RCTs). METHODS: We searched five databases. For each trial, we extracted risk ratios (RRs) of the effects of mesh or no mesh. The primary outcome was incidence of PSH with a minimum follow-up of 12 months with a clinical and/or computed tomography diagnosis. RRs were combined using the random-effect model (Mantel-Haenszel). To control the risk of type I error, we performed a trial sequential analysis (TSA). RESULTS: Seven RCTs with low risk of bias (451 patients) were included. Meta-analysis for primary outcome showed a significant reduction of the incidence of PSH using a mesh (RR 0.43, 95% CI 0.26-0.71; P = 0.0009). Regarding TSA calculation for the primary outcome, the accrued information size (451) was 187.1% of the estimated required information size (RIS) (241). Wound infection showed no statistical differences between groups (RR 0.77, 95% CI 0.39-1.54; P = 0.46). PSH repair rate showed a significant reduction in the mesh group (RR 0.28 (95% CI 0.10-0.78; P = 0.01). CONCLUSIONS: PSH prevention with mesh when creating an end colostomy reduces the incidence of PSH, the risk for subsequent PSH repair and does not increase wound infections. TSA shows that the RIS is reached for the primary outcome. Additional RCTs in the previous context are not needed.

The New 3D Printed Left Atrial Appendage Closure with a Novel Holdfast Device: A Pre-Clinical Feasibility Animal Study.

INTRODUCTION: Many patients undergoing cardiac surgery have risk factors for both atrial fibrillation (AF) and stroke. The left atrial appendage (LAA) is the primary site for thrombi formation. The most severe complication of emboli derived from LAA is stroke, which is associated with a 12-month mortality rate of 38% and a 12-month recurrence rate of 17%. The most common form of treatment for atrial fibrillation and stroke prevention is the pharmacological therapy with anticoagulants. Nonetheless this form of therapy is associated with high risk of major bleeding. Therefore LAA occlusion devices should be tested for their ability to reduce future cerebral ischemic events in patients with high-risk of haemorrhage. AIM: The aim of this study was to evaluate the safety and feasibility of a novel left atrial appendage exclusion device with a minimally invasive introducer in a swine model. MATERIALS AND METHODS: A completely novel LAA device, which is composed of two tubes connected together using a specially created bail, was designed using finite element modelling (FEM) to obtain an optimal support force of 36 N at the closure line. The monolithic form of the occluder was obtained by using additive manufacturing of granular PA2200 powder with the technology of selective laser sintering (SLS). Fifteen swine were included in the feasibility tests, with 10 animals undergoing fourteen days of follow-up and 5 animals undergoing long-term observation of 3 months. For one animal, the follow-up was further prolonged to 6 months. The device was placed via minithoracotomy. After the observation period, all of the animals were euthanized, and their hearts were tested for LAA closure and local inflammatory and tissue response. RESULTS: After the defined observation period, all fifteen hearts were explanted. In all cases the full closure of the LAA was achieved. The macroscopic and microscopic evaluation of the explanted hearts showed that all devices were securely integrated in the surrounding tissues. No pericarditis or macroscopic signs of inflammation at the site of the device were found. All pigs were in good condition with normal weight gain and no other clinical symptoms. CONCLUSION: This novel 3D printed left atrial appendage closure technique with a novel holdfast device was proven to be safe and feasible in all pigs. A benign healing process without inflammation and damage to the surrounding structures or evidence of new thrombi formation was observed. Moreover, the uncomplicated survival and full LAA exclusion in all animals demonstrate the efficacy of this novel and relatively cheap device. Further clinical evaluation and implementation studies should be performed to introduce this new technology into clinical practice.

European Hernia Society guidelines on the closure of abdominal wall incisions

BACKGROUND: The material and the surgical technique used to close an abdominal wall incision are important determinants of the risk of developing an incisional hernia. Optimising closure of abdominal wall incisions holds a potential to prevent patients suffering from incisional hernias and for important costs savings in health care. METHODS: The European Hernia Society formed a Guidelines Development Group to provide guidelines for all surgical specialists who perform abdominal incisions in adult patients on the materials and methods used to close the abdominal wall. The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and methodological guidance was taken from Scottish Intercollegiate Guidelines Network (SIGN). The literature search included publications up to April 2014. The guidelines were written using the AGREE II instrument. An update of these guidelines is planned for 2017. RESULTS: For many of the Key Questions that were studied no high quality data was detected. Therefore, some strong recommendations could be made but, for many Key Questions only weak recommendations or no recommendation could be made due to lack of sufficient evidence. RECOMMENDATIONS: To decrease the incidence of incisional hernias it is strongly recommended to utilise a non-midline approach to a laparotomy whenever possible. For elective midline incisions, it is strongly recommended to perform a continuous suturing technique and to avoid the use of rapidly absorbable sutures. It is suggested using a slowly absorbable monofilament suture in a single layer aponeurotic closure technique without separate closure of the peritoneum. A small bites technique with a suture to wound length (SL/WL) ratio at least 4/1 is the current recommended method of fascial closure. Currently, no recommendations can be given on the optimal technique to close emergency laparotomy incisions. Prophylactic mesh augmentation appears effective and safe and can be suggested in high-risk patients, like aortic aneurysm surgery and obese patients. For laparoscopic surgery, it is suggested using the smallest trocar size adequate for the procedure and closure of the fascial defect if trocars larger or equal to 10 mm are used. For single incision laparoscopic surgery, we suggest meticulous closure of the fascial incision to avoid an increased risk of incisional hernias.(AU)

European Hernia Society guidelines on the closure of abdominal wall incisions.

BACKGROUND: The material and the surgical technique used to close an abdominal wall incision are important determinants of the risk of developing an incisional hernia. Optimising closure of abdominal wall incisions holds a potential to prevent patients suffering from incisional hernias and for important costs savings in health care. METHODS: The European Hernia Society formed a Guidelines Development Group to provide guidelines for all surgical specialists who perform abdominal incisions in adult patients on the materials and methods used to close the abdominal wall. The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and methodological guidance was taken from Scottish Intercollegiate Guidelines Network (SIGN). The literature search included publications up to April 2014. The guidelines were written using the AGREE II instrument. An update of these guidelines is planned for 2017. RESULTS: For many of the Key Questions that were studied no high quality data was detected. Therefore, some strong recommendations could be made but, for many Key Questions only weak recommendations or no recommendation could be made due to lack of sufficient evidence. RECOMMENDATIONS: To decrease the incidence of incisional hernias it is strongly recommended to utilise a non-midline approach to a laparotomy whenever possible. For elective midline incisions, it is strongly recommended to perform a continuous suturing technique and to avoid the use of rapidly absorbable sutures. It is suggested using a slowly absorbable monofilament suture in a single layer aponeurotic closure technique without separate closure of the peritoneum. A small bites technique with a suture to wound length (SL/WL) ratio at least 4/1 is the current recommended method of fascial closure. Currently, no recommendations can be given on the optimal technique to close emergency laparotomy incisions. Prophylactic mesh augmentation appears effective and safe and can be suggested in high-risk patients, like aortic aneurysm surgery and obese patients. For laparoscopic surgery, it is suggested using the smallest trocar size adequate for the procedure and closure of the fascial defect if trocars larger or equal to 10 mm are used. For single incision laparoscopic surgery, we suggest meticulous closure of the fascial incision to avoid an increased risk of incisional hernias.

Thoracic endovascular aortic repair with left subclavian artery coverage without prophylactic revascularisation-early and midterm results.

BACKGROUND: The management of the left subclavian artery when coverage is necessary during thoracic aorta endografting remains a matter of debate. MATERIALS AND METHODS: A retrospective analysis of a single-centre experience with thoracic endovascular aorta repair (TEVAR) was performed. Between April 2004 and October 2012, 125 cases of TEVAR were performed. The analysis focused on patients who required coverage of the left subclavian artery (LSA). We analysed mortality and morbidity with special attention to the rates of cerebrovascular accidents (CVAs) and spinal cord ischaemia (SCI) in the early and midterm. RESULTS: Of the 125 patients, 53 (42 %, group A) required an intentional coverage of the LSA to obtain an adequate proximal seal for the endograft; the remaining patients constituted group B. None of the patients in group A had protective LSA revascularisation prior to TEVAR. The primary technical success rate was 79.2 vs. 90.3 % (group A vs. group B, p = 0.08), and the primary clinical success rate was 77.4 vs. 82 % (group A vs. group B, p = 0.53). The 30-day mortality rate was 11.3 vs. 11.1 % (group A vs. group B, p = 0.97). The 30-day morbidity was 7.5 vs. 13.9 % (group A vs. group B, p = 0.4). CVA occurred in 1.9 % of group A patients, compared to 1.4 % of patients from group B (p = 0.82). The SCI incidence rate was 0 vs. 1.4 % (p = 0.39). The mean follow-up of group A was 24.1 months (range 2-64.6 months, SD = 19). Additionally, the 1-year estimated survival was 85.5 %, and the 3-year estimated survival was 78 %. There were no midterm CVAs; one event of SCI occurred in the seventh post-operative month in group A. CONCLUSION: Our analysis, although retrospective and based on one institution experience, shows a realistic population of TEVAR patients. We prove that TEVAR with coverage of LSA origin can be accomplished with minimal neurological morbidity in this patient population. The study shows that LSA revascularisation is not mandatory before endograft deployment, especially in emergency settings. We also prove that although zone 2 TEVAR extends the proximal landing zone, it does not prevent type IA endoleaks from appearing. A multicentre randomised control trial with higher number of patients is necessary for proper, robust conclusion to be established.

European Hernia Society classification of parastomal hernias.

PURPOSE: A classification of parastomal hernias (PH) is needed to compare different populations described in various trials and cohort studies, complete the previous inguinal and ventral hernia classifications of the European Hernia Society (EHS) and will be integrated into the EuraHS database (European Registry of Abdominal Wall Hernias). METHODS: Several members of the EHS board and invited experts gathered for 2 days to discuss the development of an EHS classification of PH. The discussions were based on a literature review and critical appraisal of existing classifications. RESULTS: The classification proposal is based on the PH defect size (small is ≤5 cm) and the presence of a concomitant incisional hernia (cIH). Four types were defined: Type I, small PH without cIH; Type II, small PH with cIH; Type III, large PH without cIH; and Type IV, large PH with cIH. In addition, the classification grid includes details about whether the hernia recurs after a previous PH repair or whether it is a primary PH. Clinical validation is needed in the future to assess if the classification allows us to differentiate the treatment strategy and if the classification impacts outcome in these different subgroups. CONCLUSION: A classification of PH divided into subgroups according to size and cIH was formulated with the aim of improving the ability to compare different studies and their results.

Physical and mathematical modelling of implant-fascia system in order to improve laparoscopic repair of ventral hernia.

BACKGROUND: This paper describes an investigation of biomechanical behaviour of hernia repair, which is focused on the selection of safe linking of certain type of implant with fascia in laparoscopic operation. The strength of various fixations of the implant to the fascia is analysed. METHODS: The research is based on experimental observations of operated hernia model behaviour during a dynamic impulse load corresponding to post-operative cough. Fifty seven different types of models of implanted mesh are considered. Five types of implants and five types of connectors are used. Mechanical properties of the implants as well as limit tearing forces of joints are identified in uni-axial tensile tests. Mathematical model of implanted mesh based on finite element method is proposed. The identified mechanical properties of the materials are applied and the model is calibrated using quantities measured during experiments. FINDINGS: The presented results point at trans-abdominal sutures and ProTacks (connectors) and at DynaMesh (implant) as the most reliable materials used in ventral hernia operation, in the tested materials group. Desired properties of implants seem to be: elastic properties similar to the properties of tissues and high local strength, as fixation have a local character. The proposed mathematical model can be applied to simulate real behaviour of an implant with appropriate accuracy and to estimate the number of tacks for the implantation of hernia meshes. INTERPRETATION: The presented results may help in the deeper understanding of the fascia-mesh system behaviour, and thus may lead to improve the fixation methods.

Five-year results of a randomized clinical trial comparing a polypropylene mesh with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty.

BACKGROUND: The aim of this study was to assess whether partially absorbable monofilament mesh could influence postoperative pain and recurrence after Lichtenstein hernioplasty over the long term. METHODS: Patients were randomized into two groups that were treated with lightweight (LW) or heavyweight (HW) mesh in 15 centers in Poland. A modified suture technique was used in the lightweight mesh group. Clinical examination was performed. A pain questionnaire was completed five years after the surgery. RESULTS: Of the 392 patients who underwent surgery, 161 (90.81 %) of 177 in the HW group and 195 (90.69 %) of 215 in the LW group were examined according to protocol, a median of 62 (range 57-66) months after hernia repair. There was no difference in the recurrence rate (1.9 % LW vs. 0.6 % HW; P = 0.493). There were 24 deaths in the follow-up period, but these had no connection to the surgery. The patients treated with LW mesh reported less pain in the early postoperative period. After five years of follow-up, the intensity and the presence of pain did not differ between groups (5 patients in the LW and 4 patients in the HW group). Average pain, (VAS score), was also similar in the LW and HW group (2.25 vs. 2.4) at the fifth year postoperatively. CONCLUSION: The use of partially absorbable mesh reduced postoperative pain during the short-term postoperative period. No difference in pain or recurrence rate was observed at 60 months.

Five-year results of a randomised controlled multi-centre study comparing heavy-weight knitted versus low-weight, non-woven polypropylene implants in Lichtenstein hernioplasty.

BACKGROUND: This prospective randomised study evaluated whether non-knitted and non-woven lightweight implants can influence postoperative pain and time of return to normal activity, without increasing the recurrence rate in Lichtenstein inguinal hernioplasty. METHODS: Patients were operated on in four centres, randomised blindly into two groups with respect to the mesh used: Surgimesh WN (non-woven polypropylene microfibre sheet) and heavy weight polypropylene mesh. The operation was performed according to the Lichtenstein technique. Follow-up was designed for 7 days, and 3, 6, 12 and 60 months. The objectives were to assess the incidence of early and late complications, recurrence rate, and postoperative pain. RESULTS: A total of 220 patients were randomised; after monitoring visits (exclusion of one hospital), 202 qualified for the assessment. At 60 months, the recurrence rate did not differ statistically. Less pain on the 7th postoperative day, and at 3 months, was observed in the WN group. No other differences were observed. CONCLUSIONS: Use of a lightweight non-woven polypropylene implant is a valuable alternative to the use of knitted or woven meshes in the Lichtenstein method. Postoperative pain and recurrence were reduced at short term follow-up, but no statistical difference in recurrence rate was observed at 12 and 60 month follow-up in the patient population tested.

Assessment of usefulness exhibited by different tacks in laparoscopic ventral hernia repair.

BACKGROUND: Laparoscopic ventral hernia repair is becoming a popular technique with good results and fast postoperative recovery. The mesh is placed directly under the peritoneum and anchored with transabdominal sutures and tacks. However, the ideal size of the mesh covering the hernia orifice is know, nor the ideal type or amount of tacks has to be described. METHODS: To assess the forces acting on a single tack, a mathematical model of the ventral hernia was created. The force was described in reference to the surface of the hernia orifice and the pressure in the abdominal cavity. The following different types of mesh were examined in vitro: Proceed (knitted mesh), Dual Mesh (expanded polytetrafluoroethylene [ePTFE] flat mesh), and Shelhigh (biologic flat mesh). The following different tacks also were examined: Protac, Anchor, and EMS. A pig model was used to measure the forces needed to destroy the connection between mesh and tissue and to describe the place of destruction (mesh, tissue, or tack) and the force needed. RESULTS: The force acting on a single tack proportionally depends on the surface of the hernia orifice and the pressure in the abdominal cavity. The force needed to disconnect the tissue and mesh reached 8.97 +/- 0.11 N for ProTac, 2.67 +/- 0.22 N for Anchor, and 6.67 +/- 1.32 N for EMS. These values do not allow the mesh to be held in the right position when the orifice exceeds 10 cm for Protac and EMS. The disconnection of the EMS and Protac junction damages the tissue. Anchor tacks are insufficient to hold the mesh and stay in the tissue CONCLUSIONS: In the case of small hernias (diameter<10 cm) EMS or ProTac used alone are not enough to hold the mesh. Anchor is not recommended alone in any hernia.

Metabolic responses to enteral and parenteral nutrition.

Seven pairs of rats were simultaneously infused with a chemically formulated nutritionally complete amino acid-glucose diet which was delivered, at the same rate, into a central vein or into a feeding gastrostomy. The intragastrically infused rats showed greater weight gain than did the intravenously infused rats. This could not be explained by fluid retention since intake and output were similar in the two groups of animals. There was a greater increase in serum immunoreactive insulin (IRI) at day 8 in the intragastrically infused animals, but a smaller increment in serum immunoreactive pancreatic glucagon (IRG) at that point. Levels of enteroglucagon or glucagon-like immunoreactivity (GLI) were maintained in the intragastrically infused rats but declined markedly in the intravenously infused rats. It is possible that the greater release of IRI seen with the intragastric amino acid-glucose feeding contributes to better disposal of nutrients and greater weight gain. The presence of nutrients in the intestinal lumen may have stimulated the release of GLI, which in turn is insulinotropic.

Evaluation of intraoperative biopsy of the pancreas.

The authors carried out a retrospective review of intraoperative biopsy of the head of pancreas in 47 patients. Vim-Silverman needle biopsy (32 patients), or wedge biopsy (9 patients), or both (5 patients) were used. The correct diagnosis in the 34 patients with carcinoma was made in 76% by paraffin section and in 65% by frozen section. Diagnositic accuracy was 77% with needle biopsy and 38% with wedge biopsy. Complications occurred in six patients and consisted of pancreatitis, fistula and hemorrhage. Two patients required reoperation because of hemorrhage. The case of one patient who died of a pancreaticoperitoneal leak at the biopsy site is described in detail. The overall complication rate was 15%. These results indicate that wedge biopsy carries significant risks and frequently does not detect carcinoma. Needle biopsy is relatively safe and is more likely to provide an accurate diagnosis of carcinoma.