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1.
Hernia ; 2024 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-38366238

RESUMO

INTRODUCTION: Subcostal hernias are categorized as L1 based on the European Hernia Society (EHS) classification and frequently involve M1, M2, and L2 sites. These are common after hepatopancreatic and biliary surgeries. The literature on subcostal hernias mostly comprises of retrospective reviews of small heterogenous cohorts, unsurprisingly leading to no consensus or guidelines. Given the limited literature and lack of consensus or guidelines for dealing with these hernias, we planned for a Delphi consensus to aid in decision making to repair subcostal hernias. METHODS: We adopted a modified Delphi technique to establish consensus regarding the definition, characteristics, and surgical aspects of managing subcostal hernias (SCH). It was a four-phase Delphi study reflecting the widely accepted model, consisting of: 1. Creating a query. 2. Building an expert panel. 3. Executing the Delphi rounds. 4. Analysing, presenting, and reporting the Delphi results. More than 70% of agreement was defined as a consensus statement. RESULTS: The 22 experts who agreed to participate in this Delphi process for Subcostal Hernias (SCH) comprised 7 UK surgeons, 6 mainland European surgeons, 4 Indians, 3 from the USA, and 2 from Southeast Asia. This Delphi study on subcostal hernias achieved consensus on the following areas-use of mesh in elective cases; the retromuscular position with strong discouragement for onlay mesh; use of macroporous medium-weight polypropylene mesh; use of the subcostal incision over midline incision if there is no previous midline incision; TAR over ACST; defect closure where MAS is used; transverse suturing over vertical suturing for closure of circular defects; and use of peritoneal flap when necessary. CONCLUSION: This Delphi consensus defines subcostal hernias and gives insight into the consensus for incision, dissection plane, mesh placement, mesh type, and mesh fixation for these hernias.

2.
Hernia ; 27(2): 395-407, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-35426573

RESUMO

PURPOSE: Extended retromuscular dissection performed for abdominal wall reconstruction in complex abdominal wall repair has progressively exposed the anatomy between the peritoneal layer and abdominal wall muscles. This study aimed to assess the morphology and distribution of preperitoneal fat in a cadaveric model and its influence in retromuscular preperitoneal dissections. METHODS: Thirty frozen cadaver torsos were dissected by posterior component separation. The shape of the preperitoneal fat was identified, and the dimensions and more significant distances were calculated. RESULTS: The results showed that the preperitoneal fat resembles a trident, exists along the midline under the linea alba, and expands in the epigastric area into a rhomboid shape. The fatty triangle was found to be a part of this rhomboid. Caudally, the midline preperitoneal fat widened under the arcuate line to reach the Retzius space. Laterally, the Bogros space communicated the root of the trident with the paracolic gutters, Toldt's fascia, and pararenal fats, forming the lateral prong of the trident. The peritoneum not covered by the preperitoneal fatty trident was easy to break. Three pathways could be tracked following the distribution of this fat that facilitated the dissection of the preperitoneal space to prepare the landing zone of the meshes in hernia repair. CONCLUSION: The concept of preperitoneal fatty trident may be of practical assistance to perform various hernia procedures, from the simple ventral hernia repair to the more complex preperitoneal ventral repair or posterior component separation techniques. The consistency of this layer allows us to follow three specific pathways to find our plane between the peritoneum and muscle layers to extend the preperitoneal dissection.


Assuntos
Parede Abdominal , Hérnia Ventral , Humanos , Músculos Abdominais/cirurgia , Parede Abdominal/cirurgia , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Peritônio/cirurgia , Telas Cirúrgicas
3.
Hernia ; 26(2): 411-436, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35018560

RESUMO

PURPOSE: To assess the incidence of incisional hernia (IH) across various type of incisions in colorectal surgery (CS) creating a map of evidence to define research trends, gaps and areas of future interest. METHODS: Systematic review of PubMed and Scopus from 2010 onwards. Studies included both open (OS) and laparoscopic (LS). The primary outcome was incidence of IH 12 months after index procedure, secondary outcomes were the study features and their influence on reported proportion of IH. Random effects models were used to calculate pooled proportions. Meta-regression models were performed to explore heterogeneity. RESULTS: Ninetyone studies were included reporting 6473 IH. The pooled proportions of IH for OS were 0.35 (95% CI 0.27-0.44) I2 0% in midline laparotomies and 0.02 (95% CI 0.00-0.07), I2 52% for off-midline. In case of LS the pooled proportion of IH for midline extraction sites were 0.10 (95% CI 0.07-0.16), I2 58% and 0.04 (95% CI 0.03-0.06), I2 86% in case of off-midline. In Port-site IH was 0.02 (95% CI 0.01-0.04), I2 82%, and for single incision surgery (SILS) of 0.06-95% CI 0.02-0.15, I2 81%. In case of stoma reversal sites was 0.20 (95% CI 0.16-0.24). CONCLUSION: Midline laparotomies and stoma reversal sites are at high risk for IH and should be considered in research of preventive strategies of closure. After laparoscopic approach IH happens mainly by extraction sites incisions specially midline and also represent an important area of analysis.


Assuntos
Cirurgia Colorretal , Hérnia Incisional , Colectomia/efeitos adversos , Cirurgia Colorretal/efeitos adversos , Herniorrafia/efeitos adversos , Humanos , Hérnia Incisional/epidemiologia , Hérnia Incisional/etiologia , Hérnia Incisional/prevenção & controle , Fatores de Risco
4.
Hernia ; 25(1): 13-22, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33394256

RESUMO

PURPOSE: Incisional ventral hernias (IHs) are a common complication across all surgical specialities requiring access to the abdomen, pelvis, and retroperitoneum. This public health issue continues to be widely ignored, resulting in appreciable morbidity and expenses. In this critical review, the issue is explored by an interdisciplinary group. METHODS: A group of European surgeons encompassing representatives from abdominal wall, vascular, urological, gynecological, colorectal and hepato-pancreatico-biliary surgery have reviewed the occurrence of His in these disciplines. RESULTS: Incisional hernias are a major public health issue with appreciable morbidity and cost implications. General surgeons are commonly called upon to repair IHs following an initial operation by others. Measures that may collectively reduce the frequency of IH across specialities include better planning and preparation (e.g. a fit patient, no time pressure, an experienced operator). A minimally invasive technique should be employed where appropriate. Our main recommendations in midline incisions include using the 'small bites' suture technique with a ≥ 4:1 suture-to-wound length, and adding prophylactic mesh augmentation in patients more likely to suffer herniation. For off-midline incisions, more research of this problem is essential. CONCLUSION: Meticulous closure of the incision is significant for every patient. Raising awareness of the His is necessary in all surgical disciplines that work withing the abdomen or retroperitoneum. Across all specialties, surgeons should aim for a < 10% IH rate.


Assuntos
Técnicas de Fechamento de Ferimentos Abdominais , Hérnia Ventral , Hérnia Incisional , Hérnia Ventral/cirurgia , Herniorrafia/efeitos adversos , Humanos , Hérnia Incisional/etiologia , Hérnia Incisional/prevenção & controle , Telas Cirúrgicas
5.
Scand J Surg ; 110(1): 105-109, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31830877

RESUMO

BACKGROUND AND AIM: Talc poudrage has been used since many years for sclerosing chronic pleural effusion. Several reports have shown good results managing chronic seromas after breast, vascular, and incisional hernia surgeries. The purpose of this study is to determine the utility of talc seromadesis for the management of chronic seromas after incisional hernia surgery. MATERIALS AND METHODS: Multicentric prospective observational study including patients diagnosed of chronic seromas after incisional hernia surgery. Under local anesthesia and ultrasonographic control, two percutaneous trocars were placed in the seroma, washing the seroma cavity with 0.9% saline solution and aspirating the remaining liquid. A sample of 4 g of talcum powder was introduced in the seroma cavity, and a 15-F drain was left in place. Patients were followed each week during at least 4 weeks after drainage removal. RESULTS: Between January 2013 and December 2016, a total of six patients were enrolled in the study. Talc poudrage was performed without any complications. Drains were pulled out in a mean time of 3 (range: 2-4) weeks. One case of the chronic seromas was efficiently sclerosed with talc without recurrence in time. In three cases, the seroma recurred, and the final solution was surgical decortication of the seroma. In the other two cases, seroma also recurred and were managed with instillation of ethanol and iodine povidone. CONCLUSION: In our experience, the management of chronic seromas after incisional hernia repair with talc seromadesis is ineffective and is associated with a high rate of seroma recurrence.


Assuntos
Hérnia Incisional/cirurgia , Complicações Pós-Operatórias/tratamento farmacológico , Seroma/tratamento farmacológico , Idoso , Drenagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Talco/administração & dosagem , Falha de Tratamento
7.
BJS Open ; 4(2): 342-353, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32207571

RESUMO

BACKGROUND: Rare locations of hernias, as well as primary ventral hernias under certain circumstances (cirrhosis, dialysis, rectus diastasis, subsequent pregnancy), might be technically challenging. The aim was to identify situations where the treatment strategy might deviate from routine management. METHODS: The guideline group consisted of surgeons from the European and Americas Hernia Societies. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used in formulating the recommendations. The Scottish Intercollegiate Guidelines Network (SIGN) critical appraisal checklists were used to evaluate the quality of full-text papers. A systematic literature search was performed on 1 May 2018 and updated 1 February 2019. The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument was followed. RESULTS: Literature was limited in quantity and quality. A majority of the recommendations were graded as weak, based on low quality of evidence. In patients with cirrhosis or on dialysis, a preperitoneal mesh repair is suggested. Subsequent pregnancy is a risk factor for recurrence. Repair should be postponed until after the last pregnancy. For patients with a concomitant rectus diastasis or those with a Spigelian or lumbar hernia, no recommendation could be made for treatment strategy owing to lack of evidence. CONCLUSION: This is the first European and American guideline on the treatment of umbilical and epigastric hernias in patients with special conditions, including Spigelian and lumbar hernias. All recommendations were weak owing to a lack of evidence. Further studies are needed on patients with rectus diastasis, Spigelian and lumbar hernias.


ANTECEDENTES: Las hernias de localización rara, así como las hernias ventrales primarias en determinadas circunstancias (cirrosis, diálisis, diástasis de recto, tras un embarazo) pueden ser complejas desde el punto de vista técnico. El objetivo fue identificar situaciones en las que la estrategia de tratamiento pudiera ser diferente del tratamiento habitual. MÉTODOS: Esta guía fue elaborada por cirujanos de las sociedades europeas y americana de hernia (European Hernia Society, EHS y American Hernia Society, AHS). La búsqueda sistemática de la literatura se efectuó el 1 de mayo de 2018 y se actualizó el 1 de febrero de 2019. Para evaluar la calidad de los artículos completos seleccionados se utilizó la normativa SIGN (Scottish Intercollegiate Guidelines Network). Las recomendaciones formuladas siguieron la metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) y la redacción de la guía siguió las normas AGREE (Appraisal of Guidelines for Research & Evaluation). RESULTADOS: La literatura es limitada en cantidad y calidad. La mayoría de las recomendaciones se calificaron como débiles en función de la baja calidad de la evidencia. En pacientes con cirrosis o en diálisis, se sugiere una reparación con malla preperitoneal. Un embarazo tras la reparación de una hernia es un factor de riesgo de recidiva. La reparación debería posponerse hasta después del último embarazo. Debido a la falta de evidencia no se pudo hacer ninguna recomendación para la reparación de hernias en pacientes con diástasis de recto concomitante o con hernias de Spigel o lumbares. CONCLUSIÓN: Esta es la primera guía europea y americana del tratamiento de hernias umbilicales y epigástricas en pacientes con patologías especiales, incluyendo las hernias de Spigel y lumbares. Todas las recomendaciones fueron débiles debido a la falta de evidencia. Se necesitan más estudios en pacientes con diástasis de recto, hernias de Spigel y lumbares.


Assuntos
Hérnia Ventral/cirurgia , Herniorrafia/métodos , Guias de Prática Clínica como Assunto , Sociedades Médicas , Europa (Continente) , Hérnia Ventral/etiologia , Humanos , Laparoscopia , Cirrose Hepática/complicações , Diálise Renal/efeitos adversos , Telas Cirúrgicas , Estados Unidos
8.
Hernia ; 24(2): 369-379, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32140964

RESUMO

PURPOSE: The closure of midline in abdominal wall incisional hernias is an essential principle. In some exceptional circumstances, despite adequate component separation techniques, this midline closure cannot be achieved. This study aims to review the results of using both anterior and component separation in these exceptional cases. METHODS: We reviewed our experience using the combination of both anterior and posterior component separation in the attempt to close the midline. Our first step was to perform a TAR and a complete extensive dissection of the retromuscular preperitoneal plane developed laterally as far as the posterior axillary line. When the closure of midline was not possible, an external oblique release was made. A retromuscular preperitoneal reinforcement was made with the combination of an absorbable mesh and a 50 × 50 polypropylene mesh. RESULTS: Twelve patients underwent anterior and posterior component separation. The mean hernia width was 23.5 ± 5. The majority were classified as severe complex incisional hernia and had previous attempts of repair. After a mean follow-up of 27 months (range 8-45), no case of recurrence was registered. Only one patient (8.33%) presented with an asymptomatic bulging in the follow-up. European Hernia Society's quality of life scores showed a significant improvement at 2 years postoperatively in the three domains: pain (p = 0.01), restrictions (p = 0.04) and cosmetic (p = 0.01). CONCLUSIONS: The combination of posterior and anterior component separation can effectively treat massive and challenging cases of abdominal wall reconstruction in which the primary midline closure is impossible to achieve despite appropriate optimization of surgery.


Assuntos
Músculos Abdominais/cirurgia , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Hérnia Incisional/cirurgia , Parede Abdominal/cirurgia , Idoso , Dissecação/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Procedimentos de Cirurgia Plástica/métodos , Recidiva , Estudos Retrospectivos , Telas Cirúrgicas
9.
Br J Surg ; 107(3): 171-190, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31916607

RESUMO

BACKGROUND: Umbilical and epigastric hernia repairs are frequently performed surgical procedures with an expected low complication rate. Nevertheless, the optimal method of repair with best short- and long-term outcomes remains debatable. The aim was to develop guidelines for the treatment of umbilical and epigastric hernias. METHODS: The guideline group consisted of surgeons from Europe and North America including members from the European Hernia Society and the Americas Hernia Society. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, the Scottish Intercollegiate Guidelines Network (SIGN) critical appraisal checklists, and the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument were used. A systematic literature search was done on 1 May 2018, and updated on 1 February 2019. RESULTS: Literature reporting specifically on umbilical and epigastric hernias was limited in quantity and quality, resulting in a majority of the recommendations being graded as weak, based on low-quality evidence. The main recommendation was to use mesh for repair of umbilical and epigastric hernias to reduce the recurrence rate. Most umbilical and epigastric hernias may be repaired by an open approach with a preperitoneal flat mesh. A laparoscopic approach may be considered if the hernia defect is large, or if the patient has an increased risk of wound morbidity. CONCLUSION: This is the first European and American guideline on the treatment of umbilical and epigastric hernias. It is recommended that symptomatic umbilical and epigastric hernias are repaired by an open approach with a preperitoneal flat mesh.


ANTECEDENTES: La reparación de las hernias umbilicales y epigástricas es un procedimiento quirúrgico frecuente con una tasa esperada de complicaciones baja. Sin embargo, sigue en discusión cuál es el mejor método de reparación óptimo para obtener los mejores resultados a corto y a largo plazo. El objetivo del estudio fue desarrollar una guía para el tratamiento de las hernias umbilicales y epigástricas. MÉTODOS: El grupo para la elaboración de la guía estuvo formado por cirujanos europeos y norteamericanos junto con miembros de la European Hernia Society (EHS) y de la America's Hernia Society (AHS). Para elaborar la guía, se siguieron las recomendaciones GRADE (Grading of Recommendations Assessment, Development and Evaluation), SIGN (Scottish Intercollegiate Guidelines Network) y AGREE (Appraisal of Guidelines for Research & Evaluation). Se realizó una búsqueda sistemática de la literatura el 1 de mayo de 2018, que luego se actualizó el 1 de febrero de 2019. RESULTADOS: Los trabajos dedicados de forma específica a las hernias umbilicales y epigástricas eran muy limitados en cantidad y calidad, por lo que la mayoría de las recomendaciones que se extrajeron fueron calificadas como débiles y basadas en una baja calidad de la evidencia. La recomendación principal era utilizar una malla en la reparación de las hernias umbilicales y epigástricas para reducir la tasa de recidiva. La mayoría de las hernias umbilicales y epigástricas pueden repararse mediante un abordaje abierto con una malla plana preperitoneal. Se puede considerar el abordaje laparoscópico si el defecto de la hernia es grande o si el paciente tiene un riesgo aumentado de morbilidad de la herida. CONCLUSIÓN: Esta es la primera guía europea y americana del tratamiento de las hernias umbilicales y epigástricas. Se sugiere reparar las hernias sintomáticas umbilicales y epigástricas mediante un abordaje abierto con una malla plana preperitoneal.


Assuntos
Hérnia Abdominal/cirurgia , Hérnia Umbilical/cirurgia , Herniorrafia/métodos , Laparoscopia/métodos , Procedimentos de Cirurgia Plástica/métodos , Guias de Prática Clínica como Assunto , Sociedades Médicas , Europa (Continente) , Humanos , Telas Cirúrgicas , Estados Unidos
10.
Hernia ; 24(3): 645-650, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31493053

RESUMO

PURPOSE: Assess the utility of a hands-on workshop on abdominal wall reconstruction for teaching the posterior components separation (PCS) with transversus abdominis release. METHODS: Our department has been organizing a training course on abdominal wall reconstruction for the last 6 years. It is a 2-day-long course and 10-12 surgeons with experience in abdominal wall surgery attend to every course. The first day is dedicated to theoretical lectures and two simultaneous live surgeries, and the second day there is a cadaver dissection. Feedback from the trainees was collected at the end of the workshop. A survey was sent to all the surgeons who had completed the course at least a year ago, to inquire how the course had improved their surgical practice. RESULTS: From 2013 to April 2017, we have made 15 editions of the course. A total of 192 surgeons from Europe, South Africa and Middle East attended. All the surgeons answered the survey that was carried out at the end of the course. It showed a very high level of satisfaction in more than 98% of the cases. The second survey was answered by 79 surgeons (41.15%). 96% of the surgeons had modified, after attending the course, their way of dealing with complex abdominal wall problems. Only 29% of the surgeons had made a TAR before attending the course, while 86% are performing it after attending the course and 60% do it on a regular basis. In fact, 43% of surgeons have performed more than five posterior component separations in the last year. CONCLUSIONS: A workshop of abdominal wall surgery that combines live surgery, theoretical content and a cadaver lab can be a very useful tool to expand the use of new surgical techniques.


Assuntos
Músculos Abdominais/cirurgia , Parede Abdominal/cirurgia , Educação , Procedimentos de Cirurgia Plástica/educação , Avaliação de Programas e Projetos de Saúde , Parede Abdominal/anatomia & histologia , Abdominoplastia/educação , Abdominoplastia/métodos , Cadáver , Dissecação/educação , Dissecação/métodos , Europa (Continente) , Pesquisas sobre Atenção à Saúde , Humanos , Internet , Procedimentos de Cirurgia Plástica/métodos
11.
Med Intensiva (Engl Ed) ; 43(9): 569-577, 2019 Dec.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31377023

RESUMO

Despite low mortality in patients undergoing major abdominal surgery, the number of high-risk patients is increasing and has become a health problem. At present, surgery is understood as a continuous process, in which numerous guidelines added to less invasive techniques offering a lesser physiological impact upon patients with serious comorbidities are responsible for the final outcome. The prevention, identification and early treatment of complications prove as important as the preoperative or surgical technique.?The introduction of ERAS (enhanced recovery after surgery) protocols is the cornerstone for the management of these patients, and is advocated by most surgical societies for reducing mortality, length of hospital stay and hospital costs. The postoperative management of these patients in postsurgery Intensive Care Units guarantees effectiveness and efficiency in maintaining optimum patient care.


Assuntos
Abdome/cirurgia , Recuperação Pós-Cirúrgica Melhorada , Unidades de Terapia Intensiva , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios/métodos , Analgesia , Anestesia/normas , Antibioticoprofilaxia , Métodos de Alimentação , Hidratação , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Monitorização Fisiológica/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Período Pós-Operatório , Tromboembolia Venosa/prevenção & controle
14.
Hernia ; 22(6): 1113-1122, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30288617

RESUMO

BACKGROUND: The prevalence of incisional hernias (IHs) is still high after midline laparotomy (ML). There is an increasing body of evidence that prophylactic mesh placement (PMP) can be safe and efficient in the short-term outcomes, but there still are some concerns about the potential long-term complications of these meshes. This study describes our long-term PMP experience. METHODS: Observational and prospective study including all patients undergoing the use of prophylactic onlay large-pore polypropylene meshes for the closure of ML since 2008 to 2014. Outcome measures included demographics, perioperative details, wound complications, recurrences, reoperations and chronic complications. RESULTS: A cohort of 172 patients was analysed: 75% elective surgery, 25% emergency cases. Mean age was 68 years with mean body mass index (BMI) of 28.6 kg/m2. Wound classification: 6.4% clean; 85% clean-contaminated; 1.2% contaminated and 8.1% dirty. Follow-up of patients was up to 8 years (mean: 5 ± 1.6). Two meshes were removed due to chronic infection in first six postoperative months. Of the 13 patients (9.02%) who developed IH, 5 of them have been reoperated for IH repair without any difficulty related to previous mesh. During follow-up, 8 patients have been reoperated for other reasons and the integrity of abdominal wall was also checked. After the comparative study, higher BMI and emergency surgery were still risk factors for IH despite PMP. CONCLUSIONS: In our setting, the use of polypropylene prophylactic meshes in MLs is safe, efficient and durable.


Assuntos
Hérnia Ventral/prevenção & controle , Hérnia Incisional/prevenção & controle , Procedimentos Cirúrgicos Profiláticos/métodos , Implantação de Prótese/métodos , Telas Cirúrgicas , Parede Abdominal/cirurgia , Técnicas de Fechamento de Ferimentos Abdominais , Idoso , Materiais Biocompatíveis , Feminino , Hérnia Ventral/etiologia , Humanos , Hérnia Incisional/etiologia , Laparotomia/efeitos adversos , Laparotomia/métodos , Masculino , Pessoa de Meia-Idade , Polipropilenos , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento , Cicatrização
16.
Eur J Cancer ; 101: 263-272, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30054049

RESUMO

BACKGROUND: This multicentre, randomised, and phase II study evaluated mFOLFOX+cetuximab followed by maintenance mFOLFOX+cetuximab or single-agent cetuximab in metastatic colorectal cancer (mCRC) patients (NCT01161316). PATIENTS AND METHODS: Previously, untreated mCRC patients (wild-type KRAS) were randomised to receive cetuximab+mFOLFOX-6 (8 cycles for 2 weeks) followed by maintenance therapy: single-agent cetuximab (Arm-A) or mFOLFOX-6 + cetuximab (Arm-B) until progression. Primary endpoint was progression-free survival (PFS) at 9 months. RESULTS: One hundred ninety-three patients (median [range] age 60 [33-74] years) were randomised (2:1): 129 Arm-A versus 64 Arm-B. PFS at 9 months (95% confidence interval) showed non-inferiority between arms (Arm-A/Arm-B: 60 [52, 69]%/72 [61, 83]%, p [non-inferiority]<0.1). There were no statistically significant differences in the PFS (Arm-A/Arm-B: 9 [95% CI 7, 10] months/10 [7,13] months, hazard ratio [HR] = 1.19 [0.80, 1.79]) or overall survival (23 [19, 28] months/27 [18, 36] months, HR = 1.24 [0.85, 1.79]) between arms. The objective response rate was also similar (48 [39, 57]%/39 [27, 52]%). The safety profile was similar between arms, and all patients experienced at least one adverse event (AE) (Arm-A/Arm-B grade ≥III AEs: 70%/68%). The most common grade ≥III AEs were as follows: neutropenia (Arm-A/Arm-B: 28%/26%), rash acneiform (15%/24%) and sensory neuropathy (2%/15%) in any group. Arm-A was associated with less grade ≥III rash and sensory neuropathy and a lower rate of serious AEs (20%/27%). CONCLUSION(S): This phase II exploratory trial with a non-inferiority design suggests that maintenance therapy with single-agent cetuximab following mFOLFOX+cetuximab induction could be a valuable option compared with mFOLFOX+cetuximab treatment continuation. We await phase III trials to confirm single-agent cetuximab as maintenance therapy in mCRC patients.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cetuximab/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Cetuximab/administração & dosagem , Neoplasias Colorretais/genética , Neoplasias Colorretais/patologia , Intervalo Livre de Doença , Exantema/induzido quimicamente , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Humanos , Leucovorina/administração & dosagem , Leucovorina/efeitos adversos , Quimioterapia de Manutenção , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Neutropenia/induzido quimicamente , Compostos Organoplatínicos/administração & dosagem , Compostos Organoplatínicos/efeitos adversos , Proteínas Proto-Oncogênicas p21(ras)/genética
17.
Angiología ; 69(6): 348-353, nov.-dic. 2017. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-169932

RESUMO

Introducción: Los pacientes portadores de aneurisma de aorta abdominal (AAA) tienen un mayor riesgo cardiovascular. La cirugía abierta ha sido el tratamiento tradicional; sin embargo, el abordaje endovascular ha crecido exponencialmente en los últimos años debido al menor riesgo perioperatorio. La rigidez arterial parece elevarse tras el implante de endoprótesis aórtica. Material y métodos: Presentamos un subestudio del estudio registrado en la web del National Institutes of Health (ClinicalTrials.gov) como NCT02642952. Describimos 3 grupos que han recibido diferentes endoprótesis aórticas como tratamiento de un AAA. El grupo A fue tratado mediante el implante de una endoprótesis aórtica bifurcada estándar, el grupo B mediante una endoprótesis ramificada (4 ramas) y el grupo C con una endoprótesis de sellado del saco. Cada grupo incluye 2 pacientes. Hemos analizado los cambios individuales en la rigidez arterial mediante el análisis de la onda de pulso carótido-radial (AOP) y el índice de aumento (IA). Resultados: Todos los pacientes estudiados fueron varones, mayores de 70 años, con AAA en rango quirúrgico y alto riesgo quirúrgico (ASA III). Hemos observado cambios variables del AOP carótido-radial y del IA(a)75 en el postoperatorio en los pacientes incluidos. Conclusiones: Nuestro estudio muestra que los dispositivos endovasculares en el tratamiento de los AAA están implicados en el cambio de los Diferentes parámetros de rigidez arterial. Nuevos estudios aleatorizados y con mayor tamaño muestral son necesarios para comparar los diferentes tipos de endoprótesis aórticas. El impacto cardiovascular a largo plazo de estos dispositivos requiere más estudios (AU)


Introduction: Patients with diagnosis of abdominal aortic aneurysm (AAA) are known to have an increased cardiovascular risk. Open surgery has been the traditional approach however, endovascular repair has widely expanded due to the lower peri-operative risk. Arterial stiffness has been suggested to change and elevate after aortic stent-graft implantation. Material and methods: As part of a study registered in National Institutes of Health website (ClinicalTrials.gov) with NCT02642952, a description is presented of 3 groups with endovascular treatment of AAA with different endografts and mechanisms. Group A with standard bifurcated endograft, group B with a branched (4 branches) device, and group C with a sac sealing device. Each group included 2 patients. A report is presented on the individual changes of arterial stiffness measured by carotid-radial pulse wave velocity (PWV) and Augmentation Index (AIx). Results: All the patients included were men, older than 70 years, with AAA greater than 55 mm, and high-risk (ASAIII) patients. We observed a variable change in carotid-radial PWV and IA(a)75 in the postoperative period in all patients studied. Conclusions: It seems that endovascular devices in the treatment of AAAs are implicated in the change of arterial stiffness measurements. More randomised studies, with larger samples comparing the different types of endografts are required. The long-term impact on cardiovascular outcomes needs further investigation (AU)


Assuntos
Humanos , Masculino , Idoso , Rigidez Vascular/fisiologia , Aneurisma Aórtico/cirurgia , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Stents , Fatores de Risco , Análise de Onda de Pulso/métodos
20.
Angiología ; 68(5): 379-387, sept.-oct. 2016. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-155984

RESUMO

INTRODUCCIÓN: Las infecciones de endoprótesis aórticas son infrecuentes pero devastadoras. El tratamiento no está estandarizado, resultando una decisión compleja y en muchos casos urgente. OBJETIVOS: Describir el diagnóstico, el tratamiento y la evolución de los casos de infección de endoprótesis aórtica abdominal (EVAR) y torácica (TEVAR) tratados en un único centro. MÉTODOS: Estudio observacional, retrospectivo, descriptivo que incluyó pacientes con infección endoprotésica tratados entre 1998 y 2015. Se recogió la indicación del implante inicial, intervenciones posteriores, tiempo hasta la infección, clínica, pruebas complementarias, tratamiento y evolución. RESULTADOS: Registramos 9 infecciones: 5 EVAR (1,2%) y 4 TEVAR (4,2%). La mediana de edad fue de 77 años (rango, 62-85). Detectamos 5 infecciones tras implantes urgentes (5 de 9) y 3 tras intervenciones secundarias (3 de 9). La mediana de tiempo hasta la infección fue de 3,5 meses (rango, 0-109,5). Realizamos 7 explantes de endoprótesis (5 EVAR y 2 TEVAR), con reparación in situ con prótesis de dacrón-plata (n=5) o bypass axilobifemoral (n=2). En 2 TEVAR el tratamiento fue conservador por elevado riesgo quirúrgico dadas sus comorbilidades. La mortalidad a 30 días fue del 44,4% (4 de 9 pacientes), todos tras tratamiento quirúrgico. La mortalidad global fue del 66,6% (6 de 9 pacientes). Solo falleció un paciente con tratamiento conservador tras 2 años de seguimiento debido a una fístula aortoesofágica. Tres pacientes están en seguimiento (2 explantes y uno conservador) tras 121, 74 y 51 meses, respectivamente. CONCLUSIONES: La mortalidad de los pacientes con infección endoprotésica es elevada, independientemente del tratamiento. El tratamiento conservador es una buena opción en nuestra experiencia, y la cirugía, una alternativa que debería emplearse en función de las características del paciente


INTRODUCTION: Aortic endograft infections are uncommon. However, they are usually life-threatening. Treatment is not standardised, making this disease complex, and in most cases, an urgent situation. OBJECTIVES: To describe the diagnosis, treatment, and follow-up of all cases diagnosed with infected aortic endograft (abdominal-EVAR, and thoracic-TEVAR) in our Hospital. METHODS: An observational and retrospective study was conducted using data collected between 1998 and 2015. A descriptive analysis is presented on the primary indication for treatment, secondary procedures, the time-lapse between the diagnosis and primary treatment, type of repair, follow-up, and mortality. RESULTS: Of the 9 patients with infected aortic endografts, 5 were with EVAR (1.2%) and 4 with TEVAR (4.2%). The median age was 77 years (range, 62-85). Five patients received a primary urgent endograft (5 of 9). Three patients had secondary procedures before the infection diagnosis (3 of 9). The median time between primary repair and diagnosis was 3.5 months (range, 0-109.5). Explantation was performed on 7 patients. Two patients received medical treatment due to their increased surgical risk. The 30 day mortality was 44.4% (4 of 9 patients), and the overall mortality was 66.6% (6 of 9 patients). One patient with medical treatment died due to an aortic-oesophageal fistula after 2 years of follow-up. Three patients are still alive (2 explantations, and 1 with medical treatment) after 121, 74, and 51 months, respectively. CONCLUSIONS: Endograft infections mortality is high, despite the treatment used. Medical treatment is a good choice in our experience. Surgical treatment is an alternative depending on the fitness and comorbidities of the patient


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Stents/efeitos adversos , Prótese Vascular/efeitos adversos , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/prevenção & controle , Estudo Observacional , Estudos Retrospectivos , Aorta/cirurgia , Procedimentos Endovasculares/métodos
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