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1.
Sci Rep ; 13(1): 17504, 2023 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-37845369

RESUMO

This study investigates the mechanical behavior of the Physiomesh/Securestrap system, a hernia repair system used for IPOM procedures associated with high failure rates. The study involved conducting mechanical experiments and numerical simulations to investigate the mechanical behavior of the Physiomesh/Securestrap system under pressure load. Uniaxial tension tests were conducted to determine the elasticity modulus of the Physiomesh in various directions and the strength of the mesh-tissue-staple junction. Ex-vivo experiments on porcine abdominal wall models were performed to observe the system's behavior under simulated intra-abdominal pressure load. Numerical simulations using finite element analysis were employed to support the experimental findings. The results reveal nonlinearity, anisotropy, and non-homogeneity in the mechanical properties of the Physiomesh, with stress concentration observed in the polydioxanone (PDO) stripe. The mesh-tissue junction exhibited inadequate fixation strength, leading to staple pull-out or breakage. The ex-vivo models demonstrated failure under higher pressure loads. Numerical simulations supported these findings, revealing the reaction forces exceeding the experimentally determined strength of the mesh-tissue-staple junction. The implications of this study extend beyond the specific case of the Physiomesh/Securestrap system, providing insights into the mechanics of implant-tissue systems. By considering biomechanical factors, researchers and clinicians can make informed decisions to develop improved implants that mimic the mechanics of a healthy abdominal wall. This knowledge can contribute to better surgical outcomes and reduce complications in abdominal hernia repair and to avoid similar failures in future.


Assuntos
Parede Abdominal , Hérnia Abdominal , Animais , Suínos , Parede Abdominal/cirurgia , Hérnia Abdominal/cirurgia , Causalidade , Herniorrafia/métodos , Módulo de Elasticidade , Fenômenos Biomecânicos
2.
Surg Innov ; 30(6): 703-710, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37819833

RESUMO

OBJECTIVE: The aim of the ILAM (Individualized Laparoscopic Anatomical Mesh) study was to create and implant a fully individualized mesh based on CT scans, taking into account the published body of knowledge about the material and mechanical behavior of the implant for laparoscopic inguinal hernia repair. SUMMARY BACKGROUND DATA: The team creating and conducting this study consisted of surgeons and engineers. A specific project was made and divided into 4 phases. METHODS: The process of development and implantation was divided into 4 milestones: CT scans and modeling based on predefined subgroups, mesh manufacture, certification and clinical evaluation. RESULTS: The result of the study was the first individually designed hernia mesh to have been implanted in a human subject. After 12 months of follow-up, no recurrences or other complications were reported. CONCLUSIONS: The new mesh provides a better anatomic fit to the patients' inguinal region geometry. Mechanical stability is ensured by the multiple contact points between the implant and the tissues, which generate friction forces. Together with the possibility of shape design (proper overlap), the authors believe that there is no need for mesh fixation. If so, the use of such design meshes can change the guidelines in laparoendoscopic hernia repair in the future.


Assuntos
Hérnia Inguinal , Laparoscopia , Humanos , Hérnia Inguinal/cirurgia , Polipropilenos , Telas Cirúrgicas , Laparoscopia/métodos , Próteses e Implantes , Herniorrafia/métodos , Resultado do Tratamento
3.
Trials ; 24(1): 572, 2023 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-37670376

RESUMO

BACKGROUND: International guidelines of groin hernia treatment strongly recommend to fixate the mesh in large M3 medial defects during TAPP/TEP procedures. The main purpose of fixation is to decrease the recurrence rate which is alarmingly high in case of those defects. In 2022, a team consisting of hernia surgeons and scientists from universities of technology conducted an experimental study with the use of 3D groin model to verify the hypothesis that fixation is not necessary in above cases. Experiment showed that rigid and anatomically shaped meshes are able to maintain its position in the groin without fixation. Similar conclusions were recently published in Swedish database registry analysis. To confirm above results, we decided to conduct a multicenter randomized controlled trial. METHODS: Main objective of MEFI Trial is to verify the hypothesis that non-fixation of spatial, standard polypropylene meshes is non-inferior to fixation of flat, polypropylene lightweight meshes in M3 hernias by laparoendoscopic approach. Eleven large surgery centers in Poland having proficiency in laparoendoscopic groin hernia repairs were recruited for this study. Recurrence in 12-month follow-up was set as a primary endpoint. Pain sensation (Visual Analog Scale) and incidence of other complications (hematoma, seroma, SSI) were also noted. Based on the statistical analysis, minimal sample size in both arms was established at 83-102. The first arm (control) consists of patients undergoing a repair with the use of a flat, macroporous mesh with fixation using histoacryl glue. In the second arm, patients will be operated with the use of anatomically shaped, standard-weight mesh without fixation. Study will be double-blinded (patient/surgeon). After the dissection of preperitoneal space, surgeon will open a sealed envelope and find out which technique he will have to perform. Follow-up will be performed by Study Secretary (also blinded to the method used) via phone call 3 and 12 months after surgery. DISCUSSION: Based on experimental study and recent registry analysis, we believe that the recurrence rate in both groups would be on the same level, giving hernia societies a strong argument for amending the guidelines. TRIAL REGISTRATION: ClinicalTrials.gov NCT05678465. Registered on 10 January 2023.


Assuntos
Hérnia Inguinal , Cirurgiões , Humanos , Dissecação , Estudos Multicêntricos como Assunto , Polipropilenos , Ensaios Clínicos Controlados Aleatórios como Assunto , Telas Cirúrgicas
4.
ANZ J Surg ; 93(6): 1594-1598, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37012635

RESUMO

INTRODUCTION: Seromas refer to collections of fluid secreted into the so-called dead spaces when extensive dissection takes place. Various methods of preventing seroma have been reported in the literature but their outcomes are far from spectacular. AIM: To verify the expected benefit on usage of IHSI (intra-operative hypertonic saline irrigation) in aspect of decreasing subcutaneous fluid secretion and decreased hospital stay in patients undergoing various abdominal wall reconstruction procedures. MATERIAL AND METHODS: We conducted a cohort study of total 64 patients treated by two techniques and divided into 2 groups. In the first group (SUBLAY), we assessed patients undergoing abdominal wall reconstruction with the positioning mesh underneath the rectus muscles. Group was divided into two subgroups: control and experimental. In second group (ONLAY), we analysed patients who had undergone reconstruction procedure combined with abdominoplasty and placement of a mesh between the subcutaneous tissue and the fascia. Intervention consisted in administration of 20 mL of 10% hypertonic saline into subcutaneous tissue 10 min before definitive wound closure. RESULTS: Mean drain output, starting from day 2 post-op, was significantly lower in the experimental subgroups of the ONLAY and SUBLAY compared to the respective control subgroups. This had a beneficial effect on shortening the time to drainage removal. CONCLUSIONS: In the short-term results, we demonstrated that intraoperative hypertonic saline irrigation significantly decreased the amount of the drained fluid and shortened the hospital stay. Further multicentre studies in larger groups of patients are needed.


Assuntos
Parede Abdominal , Abdominoplastia , Hérnia Ventral , Humanos , Estudos de Coortes , Parede Abdominal/cirurgia , Hérnia Ventral/cirurgia , Seroma/prevenção & controle , Projetos Piloto , Abdominoplastia/métodos , Telas Cirúrgicas , Complicações Pós-Operatórias/cirurgia
5.
Pol Przegl Chir ; 95(4): 1-5, 2023 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-36808061

RESUMO

INTRODUCTION: Correct surgical technique and perioperative care are two factors that can reduce the number of complications, improve treatment outcomes and shorten the length of hospital stay. The introduction of enhanced recovery protocols has changed the approach to patient care in some centers. However, there are significant differences among centers, and in some the standard of care has remained unchanged. AIM: the goal of the panel was to develop recommendations for modern perioperative care in accordance with current medical knowledge in order to reduce the number of complications associated with surgical treatment. An additional goal was to optimize and standardize perioperative care among Polish centers. MATERIALS AND METHODS: the development of these recommendations was based on a review of the available literature from the PubMed, Medline and Cochrane Library databases from January 1, 1985 to March 31, 2022, with particular emphasis on systematic reviews and clinical recommendations of recognized scientific societies. Recommendations were formulated in a directive form and were assessed using the Delphi method. RESULTS AND CONCLUSIONS: 34 recommendations for perioperative care were presented. They cover aspects of pre-, intra- and post-operative care. Implementation of the presented rules allows to improve the results of surgical treatment.


Assuntos
Procedimentos Cirúrgicos Eletivos , Assistência Perioperatória , Humanos , Consenso , Assistência Perioperatória/métodos , Complicações Pós-Operatórias , Tempo de Internação
6.
Surg Endosc ; 37(3): 1781-1788, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36229552

RESUMO

BACKGROUND: Although international guidelines recommend not fixing the mesh in almost all cases of laparoendoscopic repairs, in case of large direct hernias (M3) mesh fixation is recommended to reduce recurrence risk. Despite lack of high-quality evidence, the recommendation was upgraded to strong by expert panel. The authors conducted a research experiment to verify the hypothesis that it is possible to preserve the mesh in the operating field in large direct hernias (M3) without the need to use fixing materials. METHOD: The authors conducted an experiment with scientists from Universities of Technology in a model that reflects the conditions in the groin area. By simulating conditions of the highest possible intra-abdominal pressure, they examined the mesh behavior within the groin and its ability to dislocate under the forces generated by this pressure. The experiment involved six spatial implants and one flat macroporous mesh. RESULTS: Heavyweight spatial meshes and lightweight spatial-individualized meshes showed no tendency to dislocate or move directly to the orifice, which was considered a rapid hernia recurrence. Lightweight meshes, both spatial and flat, underwent significant migration and shifting toward the hernial orifices. CONCLUSION: Based on the results, we believe that mesh fixation is not the only alternative to preventing recurrence in complex defects. Similar effects can be achieved using a larger, more rigid, and anatomically fitted implant. The type of implant (rather than its fixation) seems to be a key factor from the point of view of mechanics and biophysics. Clinical trials confirming the results in vivo will allow to supplement or amend the guidelines for the treatment of large inguinal hernias.


Assuntos
Hérnia Inguinal , Laparoscopia , Humanos , Laparoscopia/métodos , Virilha/cirurgia , Telas Cirúrgicas , Hérnia Inguinal/cirurgia , Herniorrafia/métodos , Recidiva
7.
BMC Surg ; 22(1): 305, 2022 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-35941642

RESUMO

BACKGROUND: Post-partum abdominal wall insufficiency (PPAWI) with rectus diastasis is present in over 30% of women after pregnancy. Little is known about how PPAWI affects the social, sexual life and self-esteem of patients. This study was designed to evaluate the safety of onlay mesh combined with abdominoplasty and its impact on the well-being of the patients. METHOD: Two hundred patients with PPAWI underwent surgery with onlay mesh and abdominoplasty. The safety of the procedure was assessed by postoperative complications, time of hospitalization and time of drainage. Before the operation and 6 months later, a questionnaire asking about the patient's sexual and social life and the presence of back pain was completed. The final cosmetic effect was assessed separately. RESULTS: The onlay procedure with abdominoplasty was found to be safe and fast. The mean operation time was 82 min, and the drainage time was 2.1 days. In this group < 2% postoperative complications were noted. There were no recurrences within the 6 month. Significant improvements in social and sexual life and the level of self-esteem were noted. Back pain was relieved or minimalized in all patients. The final cosmetic effect was insufficient for 2 patients (1%). CONCLUSION: PPAWI can be treated safely with onlay mesh and abdominoplasty. The patients' symptoms were strongly correlated with the morphological status of the front abdominal wall and improved after the procedure. Describing the psychological and social consequences of PPAWI should lead the surgical societies to propose a definition of a new disease called PPAWIS (post-partum abdominal wall insufficiency syndrome).


Assuntos
Parede Abdominal , Cirurgiões , Parede Abdominal/cirurgia , Dor nas Costas , Feminino , Humanos , Complicações Pós-Operatórias/epidemiologia , Período Pós-Parto , Gravidez , Telas Cirúrgicas/efeitos adversos
8.
Pol Przegl Chir ; 95(3): 1-5, 2022 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-36805989

RESUMO

INTRODUCTION: The paper aims to establish the legal nature of the guidelines in the Polish legal system and the possible formal consequences of introducing such guidelines (litigation, professional responsibility) as well as practical implications concerning the method of treating patients. METHODS: Analysis is clarifying fundamental issues that largely determine the content of the study. The basic assumption is to analyze the legal nature of the prepared guidelines from the point of view of public law, i.e. from the point of view of the relations occurring between the state, as the primary public law entity, and individual, private entities, such as natural persons, legal persons, or organizational units without legal personality, i.e., to be more precise, e.g., the relations between state authorities and persons practicing the medical professionConclusions:Treatment guidelines fall outside the scope of the universally applicable law subsystem. Therefore, they do not constitute sources of universally binding law. 2. Furthermore, the guidelines do not constitute sources of domestic law, as the issuing bodies have no legal authority to issue them and to mould the legal situation of their addressees. 3. In the regulations shaping the rules of practicing the medical profession, both statutory and corporate (the Medical Ethics Code), the guidelines may constitute the basis for adjudicating on the professional (disciplinary) liability of a physician. 4. The guidelines may pose a barrier to the development of medicine, especially in cases where their issuance by ad hoc groups and the lack of updates lead to the consolidation of outdated clinical practice and inhibit the research potential generated from the bottom up.


Assuntos
Médicos , Sociedades Científicas , Humanos , Polônia , Personalidade , Grupo Social
9.
Ann Surg ; 273(1): 57-65, 2021 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-33332873

RESUMO

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).


Assuntos
Bioprótese , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Laparoscopia , Telas Cirúrgicas , Adulto , Idoso , Método Duplo-Cego , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Resultado do Tratamento
10.
Clin Biomech (Bristol, Avon) ; 78: 105076, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32535476

RESUMO

BACKGROUND: Ventral hernia repair needs to be improved since recurrence, postoperative pain and other complications are still reported in many patients. The behavior of implants in vivo is not sufficiently understood to design a surgical mesh mechanically compatible with the human abdominal wall. METHODS: This analysis was based on radiological pictures of patients who underwent laparoscopic ventral hernia repair. The pictures show the trunk of the patient at rest in a standing position and under side bending. The change in the distance between different tacks due to trunk movement was analyzed, which allowed us to determine the in vivo elongation of the mesh incorporated into the abdominal wall. FINDINGS: The relative elongations of the surgical mesh varied from a few percent to greater than 100% in two cases. The median of the median relative elongations obtained for all patients is 9.5%, and the median of the maximum relative elongations for all patients is 32.6%. The maximum elongation occurs between tacks that are next to each other. Trunk movement causes implant deformation, and this study provides quantitative information regarding changes in the distance between fasteners. INTERPRETATION: The physiological movement of the human abdomen must be regarded as a very important factor in mesh deformation and should be considered in surgical practice to reduce the hernia recurrence rate and postoperative pain.


Assuntos
Hérnia Ventral/cirurgia , Herniorrafia/instrumentação , Telas Cirúrgicas , Parede Abdominal/cirurgia , Adulto , Feminino , Herniorrafia/efeitos adversos , Humanos , Laparoscopia , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Próteses e Implantes , Recidiva , Resultado do Tratamento , Adulto Jovem
11.
Wideochir Inne Tech Maloinwazyjne ; 13(3): 412-416, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30302157

RESUMO

Anterior abdominal wall reconstruction surgery in patients who have undergone multiple laparotomies is associated with a high risk of complications. For this reason, minimally invasive surgery techniques are used to avoid abdominal compartment syndrome, to enhance wound healing and to reduce postoperative pain and blood loss. This paper presents a case of a patient who was admitted to the Department of General Surgery in Puck Hospital as a result of extensive anterior abdominal wall deformation with an end descending colostomy. A single-stage procedure was performed: specifically, digestive tract reconstruction followed by anterior abdominal wall reconstruction using intraoperative angiography of indocyanine green in infrared light.

12.
Pol Przegl Chir ; 89(5): 12-18, 2017 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-29154246

RESUMO

In the therapy of an inguinal hernia, there is a huge variety in the way of treating and the choice of surgical technique. Practice shows that the intraoperative improvisation and surgeons' own modifications of the original techniques have become part of routine procedure. No mandatory hernia registration system causes the actual detailed herniology status in our country remains unknown. The aim of the study was to summarize the results of a survey on knowledge of a hernia according to the standards developed by international hernia societies compared with everyday clinical practice. During the International Conference Hernia in Poland, which took place on 10 December 2016 in Zakopane we conducted an interactive session among 106 surgeons dealing with hernias. Surgeons responded to 66 questions about daily surgical practice and decision making in their centers, and 27 questions for the assessment of the world's latest treatment recommendations regarding groin hernias. The most common method of using the implant technique Lichtenstein, used by 91% of doctors. 20% of surgeons in planned operations in adult men routinely uses no mesh technique. Almost 80% of respondents do not apply TEP or TAPP. Only 45.7% of surgeons customize surgical technique to the patient. Only 7 of the 27 analyzed recommendation has been accepted by more than 90% of respondents. 9 of the 27 recommendations were approved by less than half of the surgeons. In the case of 11 recommendations, surgeons simultaneously failed to comply with these recommendations in daily practice. Deficiencies in the system of training and the underfunding of medical procedures cause insufficient TAPP/ TEP availability in Poland in an inguinal hernia. Improvement of the surgeons' knowledge on how to perform surgery.


Assuntos
Hérnia Femoral/cirurgia , Hérnia Inguinal/cirurgia , Herniorrafia/normas , Padrões de Prática Médica/normas , Endoscopia , Feminino , Humanos , Polônia , Sociedades Médicas , Telas Cirúrgicas
13.
Artigo em Inglês | MEDLINE | ID: mdl-28446927

RESUMO

INTRODUCTION: In 2012, a total of 56 647 inguinal hernia repairs were performed in Poland. However, the absence of a uniform hernia repair register obscures the current herniology status in Poland, especially regarding laparoendoscopic procedures. AIM: To determine the awareness of laparoendoscopic procedures among Polish surgeons and to ascertain their everyday clinical practice. MATERIAL AND METHODS: The data were collected at the national hernia conference in 2016, during an interactive session for surgeons with a special interest in herniology. They could respond to the survey items using the VoxVote application. All items and response options were displayed on participants' smartphones. The questions were related to transabdominal preperitoneal/totally extraperitoneal (TAPP/TEP) hernia repair. The surgeons responded to 27 questions regarding routine inguinal hernia repair. One hundred and six surgeons from all regions of Poland participated in the survey. RESULTS: 19.2% of respondents never inform patients about the possibility of performing laparoendoscopic repair. 45.2% admitted that they had referred a patient with a difficult inguinal hernia to another hospital or surgeon. Seventy-five percent stated they would be willing to perform TAPP/TEP if the reimbursement rates were more favourable. In bilateral hernias, 61.6% of the respondents perform a two-step open repair, while only 25% perform a single-stage laparoendoscopic repair of bilateral hernia. In women, only 13.3% perform laparoendoscopic hernia repairs, and 19.0% do not use mesh. CONCLUSIONS: The skill level to perform TAPP/TEP repair is still inadequate among Polish surgeons. The absence of accurate data makes it impossible to verify whether the treatment methods used are compliant with the guidelines.

14.
Wideochir Inne Tech Maloinwazyjne ; 11(3): 127-136, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27829934

RESUMO

More than 1 million inguinal hernia repairs are performed in Europe and the US annually. Although antibiotic prophylaxis is not required in clean, elective procedures, the routine use of implants (90% of inguinal hernia repairs are performed with mesh) makes the topic controversial. The European Hernia Society does not recommend routine antibiotic prophylaxis for elective inguinal hernia repairs. However, the latest randomized controlled trial, published by Mazaki et al., indicates that the use of prophylaxis is effective for the prevention of surgical site infection. Unnecessary prophylaxis contributes to the development of bacterial resistance and significantly increases healthcare costs. This review documents clinical trials on inguinal hernia repairs with mesh and summarizes the current knowledge. It also tries to solve certain problems, namely: what constitutes a real risk factor, late-onset infection, and how the "surgical environment" impacts on the need to use antibiotic prophylaxis.

15.
Front Surg ; 3: 53, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27725931

RESUMO

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.

16.
Pol Przegl Chir ; 88(1): 7-14, 2016 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-27096768

RESUMO

UNLABELLED: Laparoscopic ventral hernia repair has become popular technique. Every year, companies are introducing new products Thus, every mesh prior to introduction in clinical settings should be tested with a dedicated tacker to discover the proper fixation algorithm. The aim of the study was to assess the safety and efficacy of the Ventralight ST implant with an ECHO positioning system and a dedicated fixation device, the SorbaFix stapler, in a prospective cohort of patients. MATERIAL AND METHODS: The study was a prospective single centre cohort study with a one-year followup period. Fifty-two patients received operations for a ventral hernia using a laparoscopic IPOM mesh - Ventralight ST ECHO PS. The size of the mesh and the fixation method were based on mathematical considerations. A recurrence of the hernia and pain after 1, 2 and 12 months were assessed as the primary endpoints. RESULTS: Two recurrences were noted, one in parastomal and one in a large incisional hernia. Pain was observed in 22 patients (41%) and mostly disappeared after 3 months (7%). The intensity of pain was low (VAS <2). However, 2 patients still experienced severe pain (VAS>6) until the end of the study. CONCLUSION: The Ventralight ST Echo PS implant fixed with a Sorbafix stapler is a valuable and safe option for a laparoscopic ventral hernia repair. In our opinion, the implant could be used in all patients due to the hernia ring diameter. According to the mathematical models and clinical practice, we do not recommend this implant in orifices with a width larger than 10 cm.


Assuntos
Hérnia Ventral/cirurgia , Herniorrafia/métodos , Laparoscopia/métodos , Telas Cirúrgicas , Adesivos Teciduais/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Polônia , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento
17.
Surg Endosc ; 30(3): 1188-97, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26139491

RESUMO

BACKGROUND: Patients' need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain. METHODS: A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications. RESULTS: During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (p < 0.0001) and no difference after 7 days (p = 0. 7019). The pain intensity decreased significantly over time (p < 0.0001) and was significantly higher in the PH group (p < 0.0001). CONCLUSIONS: Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.


Assuntos
Hérnia Ventral/cirurgia , Herniorrafia/instrumentação , Laparoscopia/métodos , Telas Cirúrgicas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Estudos Prospectivos , Recidiva , Escala Visual Analógica
18.
Wideochir Inne Tech Maloinwazyjne ; 10(1): 49-56, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25960793

RESUMO

INTRODUCTION: Laparoscopic repair is becoming an increasingly popular alternative in the treatment of abdominal wall hernias. In spite of numerous studies evaluating this technique, indications for laparoscopic surgery have not been established. Similarly, implant selection and fixation techniques have not been unified and are the subject of scientific discussion. AIM: To assess whether there is a consensus on the management of the most common ventral abdominal wall hernias among recognised experts. MATERIAL AND METHODS: Fourteen specialists representing the boards of European surgical societies were surveyed to determine their choice of surgical technique for nine typical primary ventral and incisional hernias. The access method, type of operation, mesh prosthesis and fixation method were evaluated. In addition to the laparoscopic procedures, the number of tackers and their arrangement were assessed. RESULTS: In none of the cases presented was a consensus of experts obtained. Laparoscopic and open techniques were used equally often. Especially in the group of large hernias, decisions on repair methods were characterised by high variability. The technique of laparoscopic mesh fixation was a subject of great variability in terms of both method selection and the numbers of tackers and sutures used. CONCLUSIONS: Recognised experts have not reached a consensus on the management of abdominal wall hernias. Our survey results indicate the need for further research and the inclusion of large cohorts of patients in the dedicated registries to evaluate the results of different surgical methods, which would help in the development of treatment algorithms for surgical education in the future.

20.
Langenbecks Arch Surg ; 399(7): 873-7, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25168297

RESUMO

BACKGROUND: The aim of this study was to evaluate whether the type of the mesh and proper surgical technique can influence the outcome of a tension-free hernia repair in a contaminated filed. MATERIALS AND METHODS: This study was based on the model of bacterial peritonitis in rats induced with a mixture composed of Escherichia coli and Bacteroides fragilis. Two animals were used as a control group without induced peritonitis and 10 animals with mesh implanted inside of the peritoneal cavity. For the 20 animals in the studied group, bacterial fluid was applied into the abdominal cavity together with the mesh implantation. In 10 cases, the mesh was fixed flatly upon the surface of the peritoneum; in the other 10, the mesh was rolled and then fixed within the peritoneal cavity. After 5 weeks, the animals were operated on again, and the meshes, the peritoneal fluid and, if present, any granulomas were taken for bacterial cultivation. RESULTS: The results of the bacterial cultivation of the material from the control group (without mesh) and from the rats with flatly fixed mesh were almost completely negative (0/10 and 1/10, respectively). In 9 out of 10 rats that were exposed to the rolled mesh for 5 weeks, the colonisation of meshes with both B. fragilis and E. coli was found (p < 0.0198). CONCLUSIONS: When properly fixed, flat mesh, even in a contaminated field, may allow for a proper mesh healing and does not influence the ability to cure bacterial peritonitis in an animal model. A bad surgical technique, such as inadequately positioned or rolled mesh, may cause persistent peritoneal bacteraemia.


Assuntos
Infecções Bacterianas/cirurgia , Hérnia Abdominal/cirurgia , Peritonite/cirurgia , Telas Cirúrgicas , Animais , Desenho de Equipamento , Masculino , Peritonite/microbiologia , Polipropilenos , Ratos Wistar , Telas Cirúrgicas/microbiologia , Infecção da Ferida Cirúrgica/microbiologia
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