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INTRODUCTION: Achalasia is a rare esophageal motility disorder of unknown etiology. With the ageing of the general population, treatment in elderly patients has become increasingly common; however, the gold standard treatment in this population remains unclear. The aim of this study was to evaluate the outcomes of laparoscopic Heller-Dor myotomy (LHM) in geriatric patients. MATERIAL AND METHODS: In this study, consecutive achalasia patients undergoing LHM at the University Hospital 'Federico II' of Naples from November 2018 to November 2022 were prospectively enrolled. Patients were divided into two groups based on their age at intervention: elderly (≥70 years) and younger (<70 years). The two study groups were compared by minimizing the different distribution of covariates through a propensity score matching analysis (PSM). RESULTS: In both populations, there was a significant improvement in terms of manometric parameters and symptoms after surgery. After applying one-on-one PSM, we obtained a total population of 48 achalasia patients divided into two groups (24 patients each). No significant differences were found in terms of demographic characteristics as well as preoperative and intraoperative variables between two groups. At 12 months from surgery, integrated relaxation pressure (IRP) was significantly lower in patients ≥ 70 years (p = 0.032), while younger patients scored significantly less at the post-operative Eckardt score (p = 0.047). CONCLUSIONS: Laparoscopic Heller-Dor myotomy is a safe and effective treatment even in elderly patients with rapid post-operative recovery, improvement of symptoms and manometric parameters.
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Acalasia Esofágica , Miotomia de Heller , Laparoscopia , Humanos , Idoso , Acalasia Esofágica/cirurgia , Acalasia Esofágica/diagnóstico , Pontuação de Propensão , Fundoplicatura , Resultado do TratamentoRESUMO
Introduction: Achalasia is a rare primary esophageal disorder characterized by impaired functioning of the lower esophageal sphincter. The goal of treatment is to reduce symptoms and improve the quality of life. The gold standard of surgical approach is Heller-Dor myotomy. The aim of this review is to describe the use of robotic surgery in patients with achalasia. Methods: The literature review was performed by searching on PubMed, Web of Science, Scopus and EMBASE for all studies on robotic surgery for achalasia, published from January 1, 2001, to December 31, 2022. We focused our attention on randomized controlled trials (RCTs), metaanalysis, systematic reviews, and observational studies on large cohorts of patients. Furthermore, we have identified relevant articles from the reference list. Conclusions: Taking into consideration our review and experience, RHM with partial fundoplication is safe, efficient, comfortable for the surgeon and characterized by a reduction of the intraoperative perforation rate of the esophageal mucosa. This approach may represent the future for the surgical treatment of achalasia especially with a reduction in costs.
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Acalasia Esofágica , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Humanos , Acalasia Esofágica/cirurgia , Acalasia Esofágica/diagnóstico , Laparoscopia/efeitos adversos , Resultado do Tratamento , Esfíncter Esofágico Inferior/cirurgia , FundoplicaturaRESUMO
Artificial Intelligence (AI) is playing an increasing role in several fields of medicine. AI is also used during laparoscopic cholecystectomy (LC) surgeries. In the literature, there is no review that groups together the various fields of application of AI applied to LC. The aim of this review is to describe the use of AI in these contexts. We performed a narrative literature review by searching PubMed, Web of Science, Scopus and Embase for all studies on AI applied to LC, published from January 01, 2010, to December 30, 2023. Our focus was on randomized controlled trials (RCTs), meta-analysis, systematic reviews, and observational studies, dealing with large cohorts of patients. We then gathered further relevant studies from the reference list of the selected publications. Based on the studies reviewed, it emerges that AI could strongly improve surgical efficiency and accuracy during LC. Future prospects include speeding up, implementing, and improving the automaticity with which AI recognizes, differentiates and classifies the phases of the surgical intervention and the anatomic structures that are safe and those at risk.
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Artificial intelligence (AI) is playing an increasing role in several fields of medicine. It is also gaining popularity among surgeons as a valuable screening and diagnostic tool for many conditions such as benign and malignant colorectal, gastric, thyroid, parathyroid, and breast disorders. In the literature, there is no review that groups together the various application domains of AI when it comes to the screening and diagnosis of main surgical diseases. The aim of this review is to describe the use of AI in these settings. We performed a literature review by searching PubMed, Web of Science, Scopus, and Embase for all studies investigating the role of AI in the surgical setting, published between January 01, 2000, and June 30, 2023. Our focus was on randomized controlled trials (RCTs), meta-analysis, systematic reviews, and observational studies, dealing with large cohorts of patients. We then gathered further relevant studies from the reference list of the selected publications. Based on the studies reviewed, it emerges that AI could strongly enhance the screening efficiency, clinical ability, and diagnostic accuracy for several surgical conditions. Some of the future advantages of this technology include implementing, speeding up, and improving the automaticity with which AI recognizes, differentiates, and classifies the various conditions.
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BACKGROUND: Achalasia is characterized by symptoms of esophageal obstruction, preventing food consumption. However, weight loss is observed only in a subset of patients, and data from literature is conflicting. AIMS: Our study aimed at evaluating predictors of weight loss in achalasia patients and at verifying the impact of treatment on nutritional status. METHODS: 123 achalasia patients, eligible for laparoscopic Heller myotomy, were studied. Demographic, clinical and nutritional data (calorie intake and macronutrient composition) were recorded at baseline and one-year post-treatment. Significant weight loss/gain was considered for variation of 10â¯% of body weight at baseline and post-treatment, respectively. RESULTS: 57.7â¯% of patients reported weight loss at presentation. These subjects had shorter disease duration, worse symptoms, lower BMI and consumed fewer calories than patients without weight loss. Post-treatment, we observed a considerable improvement in Eckardt score and BMI values. Almost 50â¯% of the population reported significant weight gain, particularly in individuals with weight loss at baseline. Caloric intake also rose significantly, positively affecting BMI categories. CONCLUSION: We showed that achalasia-induced weight loss is associated with symptoms' severity and disease duration. Conversely, over 50â¯% of treated patients were in the overweight/obese category, highlighting the need for individualized nutritional interventions in achalasia patients.
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BACKGROUND: Laparoscopic adrenalectomy (LA) is considered the "gold standard" treatment of adrenal lesions that are often coincidentally diagnosed during the radiologic workup of other diseases. This study aims to evaluate the intraoperative role of indocyanine green (ICG) fluorescence associated with preoperative 3-dimensional reconstruction (3DR) in laparoscopic adrenalectomy in terms of perioperative outcomes. To our knowledge, this is the first prospective case-controlled report comparing these techniques. MATERIALS AND METHODS: All consecutive patients aged≥18 and undergoing laparoscopic transperitoneal adrenalectomy for all adrenal masses from January 1, 2019 to January 31, 2022 were prospectively enrolled. Patients undertaking standard LA and those undergoing preoperative 3D reconstruction and intraoperative ICG fluorescence were matched through a one-on-one propensity score matching analysis (PSM) for age, gender, BMI, CCI score, ASA score, lesion histology, tumor side, and lesion diameter. Differences in operative time, blood loss, intraoperative and postoperative complications, conversion rate, and length of stay were analyzed. RESULTS: After propensity score matching analysis, we obtained a cohort of 36 patients divided into 2 groups of 18 patients each. The operative time and intraoperative blood loss were shorter in patients of the 3DR group ( P =0,004 and P =0,004, respectively). There was no difference in terms of length of stay, conversion rate, and intraoperative and postoperative complications between the 2 groups. CONCLUSIONS: The use of intraoperative ICG in LA and preoperative planning with 3DR images is a safe and useful addition to surgery. Furthermore, we observed a reduction in terms of operating time and intraoperative blood loss.
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Neoplasias das Glândulas Suprarrenais , Laparoscopia , Humanos , Adrenalectomia/métodos , Verde de Indocianina , Pontuação de Propensão , Perda Sanguínea Cirúrgica , Laparoscopia/métodos , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Neoplasias das Glândulas Suprarrenais/cirurgiaRESUMO
Colorectal cancer has a great socio-sanitary relevance. It represents the third cancer by incidence and mortality. Ageing plays a major role in the development of colorectal cancer and this tumour, in patients aged 65 and older, has gradually increased over the past decade. The robotic technique is considered the evolution of conventional laparoscopy. Few studies evaluate the effects of robotic surgery in elderly patient, and even fewer are those that compare it with laparoscopic surgery in this population. The aim of this study was to evaluate the perioperative outcomes of robotic colorectal surgery compared to laparoscopic colorectal surgery in patients older than 65 years. We conducted a retrospective study enrolling 83 elderly patients (age > 65) undergoing robotic and laparoscopic colectomy (32 and 51, respectively) between January 2019 and January 2021. For statistical analysis, p values were calculated using t test and chi-square test. p < 0.05 is the criterion for statistical significance. Statistical analyses were performed with the Number Cruncher Statistical System (NCSS) 2020 data analysis version 20.0.1 (Utah, USA). The operation time was higher in robotic left (p = 0.003, mean time 249.6 vs 211.7 min) and right (p = 0.004, mean time 238.5 vs 183.5 min) hemicolectomy and similar for procedures on rectosigmoid and rectum when compared to laparoscopic technique. In terms of length of hospital stay and recovery of bowel function, these values were significantly lower for robotic group in left hemicolectomy (p = 0.004), rectum (p = 0.003) and rectosigmoid (p = 0.003), while right hemicolectomy was similar in two groups (p = 0.26). There was no statistically significant difference between the groups regarding conversion rate, postoperative complications, length of specimen, number of lymph nodes encountered and oncological results. Colorectal robotic surgery in elderly patients appears as a feasible and safe surgical approach when compared to the laparoscopic one, showing a shorter recovery and a reduction of length of stay with similar oncological outcomes even if with an increase of operating times.
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Neoplasias Colorretais , Cirurgia Colorretal , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Idoso , Colectomia/métodos , Neoplasias Colorretais/cirurgia , Cirurgia Colorretal/métodos , Humanos , Laparoscopia/métodos , Tempo de Internação , Duração da Cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. They are 1% of all gastrointestinal cancer and 60% of them affects the stomach. Up to 10% to 30% of GISTs are malignant. They occur in people over the age of 50 in both sexes. The most common symptoms of gastric GIST are bleeding, dyspepsia, vague abdominal pain or discomfort, and mass palpation. Some are asymptomatic and diagnosed incidentally. The first choice of treatment for primary localized gastric GISTs is surgery. The most suitable type of resection is not yet clear and it depends on size and location of tumor, especially for difficult localizations, such as subcardial, posterior wall and less curvature GISTs. METHODS: We report a rare case of a patient with subcardial gastric GIST treated with laparoscopic atypical quadrangular resection guided by intraoperative endoscopy. Furthermore, we performed a review of the literature about this topic. RESULTS: Despite the difficult localization an atypical resection of the gastric GIST was performed without breaking the lesion but preserving the lumen of the esofagogastrich junction. CONCLUSIONS: An atypical quadrangular resection for subcardial gastric GISTs, located along the posterior wall and lesser curvature, can be a safe and reliable alternative technique. However, we believe that it should be performed by an experienced surgeon and endoscopist to decrease the risk of mass's break and the narrowing of the cardial region's lumen. In our literature's knowledge there aren't cases treated with this technique. KEY WORDS: Gastric GIST, Gastrointestinal stromal tumors, Intraoperative endoscopy, Laparoscopic resection, Minimally invasive surgery.
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Tumores do Estroma Gastrointestinal , Laparoscopia , Neoplasias Gástricas , Cirurgiões , Feminino , Masculino , Humanos , Tumores do Estroma Gastrointestinal/cirurgia , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/cirurgiaRESUMO
INTRODUCTION: Leiomyosarcoma is a rare malignant mesenchymal cancer of smooth muscle and about 50-60 % of cases are from inferior vena cava. Recently, preoperative reconstruction of three-dimensional (3D) images from computed tomography (CT) and intraoperative indocyanine green (ICG) are being developed. We present a case of laparoscopic left nephro-adrenalectomy using ICG fluorescence associated with 3D-CT reconstruction:n. CASE REPORT: A 72-years-old female patient presented pain in left side from two months. Contrast computed tomography and magnetic resonance imaging showed a solid mass between left-adrenal gland and upper renal pole. After multidisciplinary evaluation, a laparoscopic left nephno-adrenalectomy was performed. DISCUSSION: The surgery was without intra and postoperative complications. The patient was discharged in the 3rd postoperative day without complications and with oral steroid replacement therapy. Histology confirmed leiomysarcoma of renal vein. CONCLUSION: In this case, use intraoperative ICG fluorescence associated with preoperative 3D-CT was a valuable support for surgery. KEY WORDS: Endocrine surgery, Indocyanine green fluorescence, Laparoscopic Nephro-Adrenalectomy, Leiomyosarcoma, Three-dimensional computed tomography reconstruction, Video surgery.
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Neoplasias das Glândulas Suprarrenais , Laparoscopia , Leiomiossarcoma , Humanos , Feminino , Idoso , Verde de Indocianina , Veias Renais/diagnóstico por imagem , Veias Renais/cirurgia , Veias Renais/patologia , Neoplasias das Glândulas Suprarrenais/cirurgia , Leiomiossarcoma/diagnóstico por imagem , Leiomiossarcoma/cirurgia , Fluorescência , Laparoscopia/métodos , Tomografia Computadorizada por Raios XRESUMO
INTRODUCTION: Cholangiography with indocyanine green fluorescence (ICG) is increasingly used to visualize the bile duct anatomy during laparoscopic cholecystectomy. Biliary leaks are rare complications after laparoscopic cholecystectomy, result could be lethal. Lesion's site is not always visible. We present an interesting case of a patient with biloma due to an iatrogenic lesion of the biliary tract, treated in urgency using ICG fluorescence. To our knowledge, this is the only case in the literature. CASE PRESENTATION: A 62-years-old patient after 7 days from laparoscopic cholecystectomy presented abdominal pain and fever. Blood tests showed an increase of inflammation indexes. Abdominal US and abdominal CT revealed a conspicuous right sub-hepatic fluid. We performed a laparoscopy using ICG fluorescence to find the biliary leak. Operative time of surgery was 60 min. There were no complications during this procedure. CONCLUSIONS: ICG is a safe and effective procedure that enables real-time visualization of the biliary system. In some cases, it can also be used in urgent surgery, where the biliary anatomy is much more complex. KEY WORDS: Biloma, Indocyanine green fluorescence, Iatrogenic biliary leaks, Urgent surgery.
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Verde de Indocianina , Humanos , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Acute cholecystitis is an acute inflammation of the gallbladder. It represents one-third of all surgical emergency hospital admissions and has significant socioeconomic impact. Laparoscopic cholecystectomy, regardless of age, is the gold standard for this disease, but the optimal timing of surgical intervention is an open issue since the 2007 Tokyo guidelines. METHODS: We recruited from March 2015 to June 2018, in a retrospective study, 144 patients with acute cholecystitis and treated with laparoscopic cholecystectomy. The patients were divided into two groups: group A (N.=66), operated within 72 hours and group B (N.=78), between 72 hours and 1 week after the onset of symptoms. After, the two groups were further stratified by the grade of severity of acute cholecystitis in according to the Tokyo guidelines: in group A, 39 patients were grade I and 27 grade II; in group B, 48 patients were grade I and 30 grade II. RESULTS: The operative time was longer in group B patients versus group A. In group B, there was a greater difficulty in dissecting and detecting the Calot's triangle, more conversions to open, a greater mean length of hospital stay and more post-operative days. In patients with grade II, especially in the group B, were greater inflammation stage, conversions to open, difficulty in the dissection of the Calot's triangle, mean length of hospital stay and post-operative days. The operative timing within 72 hours in patients with grade I, have only advantage in the mean length of hospital stay, while in grade II, the advantages are also in the lesser difficulty in dissecting the Calot's triangle, fewer conversions and fewer post-operative days. CONCLUSIONS: Early laparoscopic cholecystectomy for acute cholecystitis should be performed considering not only the onset of symptoms, but above all the grade of severity of AC in according with TG. Grade II, particularly, must be treated within 72 hours and by experienced surgeon.
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Colecistectomia Laparoscópica , Colecistite Aguda , Colecistectomia Laparoscópica/efeitos adversos , Colecistite Aguda/cirurgia , Humanos , Duração da Cirurgia , Estudos RetrospectivosRESUMO
BACKGROUND: Italy instituted a lockdown from March 10 to May 3, 2020, due to the coronavirus disease-19 pandemic. All nonessential businesses were closed during this time, and health care services were reorganized. On March 11, the Stoma Care Center started providing telehealth services for patients with a stoma. PURPOSE: This retrospective observational study describes the experience of the Stoma Care Center of the University Hospital Federico II, Naples, Italy, before and during the lockdown. METHODS: Consultation records from January 1 through April 29 were retrieved, patient demographics and reasons for consultation abstracted, and pre-lockdown (January 1 to February 29) and lockdown (March 1 to April 29) information was compared. Patients who used telehealth services were also asked to rate their satisfaction with these services on a scale of 0 (extremely dissatisfied) to 4 (extremely satisfied). The authors analyzed all consultations provided from January to April 2020 and evaluated the use of telemedicine services for patients with an ostomy. Consultations were divided into 2 groups. Group A included consultations provided from January 1 to February 29. Group B included consultations provided from March 1 to April 29, which included the lockdown period. Group B included both in-person and telemedicine consultations. RESULTS: During the pre-lockdown period, 240 in-person consultations were provided. During the lockdown period, 181 in-person and 99 telemedicine consultations were provided. The number of in-person consultations for mechanical bowel preparation and transanal irrigation system training was lower (12.5% vs 6.6% [P = .046] and 3.3% vs 0% [P = .03]), whereas the number of consults for stoma care follow-up and stoma complications was higher (202 [84.1%] vs 266 [95%]). Of the 65 patients who completed the questionnaire, 82% indicated being extremely satisfied. CONCLUSIONS: The reorganization of stoma care services, including the availability of telemedicine, did not result in a decrease in the number of consultations provided. The results suggest that stoma care services using telemedicine may provide valid support for patients with an ostomy in the future.
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COVID-19/complicações , Estomia/enfermagem , Quarentena/tendências , Adulto , COVID-19/transmissão , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Pandemias/prevenção & controle , Satisfação do Paciente , Estudos Retrospectivos , Telemedicina/métodosRESUMO
INTRODUCTION: Pheochromocytoma is an endocrine tumour of chromaffin cells. It can be diagnosed either sporadically or in the context of hereditary syndromes (e.g. Von Hippel Lindau, Neurofibromatosis type 1 and multiple neuroendocrine neoplasia type 2). During pregnancy, its frequency is very low (about 0,007%). This tumour causes paroxysmal hypertension in 0,1-0,6% pregnant women, because of an overproduction of catecholamines. If undiagnosed and nontreated, it's associated with high maternal and fetal mortality (40-50%). We report the case of a 30-year-old female diagnosed with pheochromocytoma during pregnancy at week 31 of gestation. In a multidisciplinary team made of surgeons, gynaecologists, anaesthetists, geneticists and endocrinologists we evaluated the case and according to literature, we choose a surgical approach after childbirth: performing a laparoscopic right adrenalectomy. DISCUSSION: In pregnancy, pheochromocytoma is a rare clinical condition. Gold standard treatment is laparoscopic adrenalectomy. However, the optimum timing of surgery is a challenge. CONCLUSION: Timely diagnosis of pheochromocytoma in pregnant women with hypertension and appropriate therapeutic management can lead to improve maternal, fetal and neonatal outcomes. The multidisciplinary team is necessary to recognize the symptoms and to adopt the right pre - and post - operative treatment. Laparoscopic adrenalectomy after delivery is safe and feasible even though the surgical procedure should be performed by an experienced surgeon. KEY WORDS: Pheochromocytoma, Pregnancy, Laparoscopic adrenalectomy and pregnancy, Management of pheochromocytoma, Laparoscopic adrenalectomy, Adrenalectomy, Pregnancy and pheochromocytoma.
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Neoplasias das Glândulas Suprarrenais , Adrenalectomia/métodos , Laparoscopia , Feocromocitoma , Complicações Neoplásicas na Gravidez , Neoplasias das Glândulas Suprarrenais/diagnóstico , Neoplasias das Glândulas Suprarrenais/cirurgia , Adulto , Feminino , Humanos , Feocromocitoma/diagnóstico , Feocromocitoma/cirurgia , Gravidez , Complicações Neoplásicas na Gravidez/diagnóstico , Complicações Neoplásicas na Gravidez/cirurgia , Resultado da Gravidez , Resultado do TratamentoRESUMO
INTRODUCTION: Several articles have been published on impact COVID-19 infection about reduction of surgical activity. We have focused on the differences between our surgical activity in an Emergency General Surgery department in "Cardarelli" Hospital in Naples. METHODS: This retrospective study compared the patients treated from March 9, 2020 to April 27, 2020 (Italian lockdown time) and the patients treated in the same period of 2019. We recruited 75 patients in Group A (2020) and 165 patients in Group B (2019). RESULTS: There was a reduction in hospitalizations for non-trauma disease (69 in group A and 122 in group B with p: 0.001), a reduction in transfers from other hospitals (2 patients in group A and 17 in group B with p. 0.04) and a reduction in hospitalizations for trauma disease (6 in group A and 43 in group B with p: 0.001). The severity of the disease in 2020 was greater than in the same period in 2019 and there was a higher rate of high-grade complications CONCLUSION: From data analysis, we conclude that there has been a reduction in hospitalizations and surgical interventions in our emergency surgery department. The patients, however, had a much more severe disease that resulted in a greater number of complications in the peri and post-operative time. KEY WORDS: COVID-19, Lockdown, Emergency Surgery, Severity of disease.
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COVID-19 , Hospitalização , Pandemias , SARS-CoV-2 , Procedimentos Cirúrgicos Operatórios , Controle de Doenças Transmissíveis , Serviço Hospitalar de Emergência , Cirurgia Geral , Humanos , Itália , Estudos Retrospectivos , Índice de Gravidade de Doença , Carga de TrabalhoRESUMO
INTRODUCTION: We report the case of a successful management with combined aggressive surgery and negative pressure therapy, to treat a severely ill-septic patient, affected by multiple chronic enterocutaneous fistulas. PRESENTATION OF CASE: A 26-year-old female patient presented with multiple pelvic and intra-abdominal abscesses, enterocutaneous fistulas and central venous catheter-related bacteraemia in extremely poor general conditions.The patient underwent both an abdominal CT which showed multiple digestive loops stuck and apparently fistulised and an abdominal-pelvic MRI, confirming the CT findings, and demonstrating a third fistula involving the Pouch and responsible for a pelvic and retroperitoneal chronic abscess.Given the patient's septic condition, despite several attempts of conservative therapies, an aggressive surgical approach was adopted.After temporary abdominal wall closure, the patient underwent Vacuum Assisted Closure therapy in order to close the abdominal wall and drain the residual abscess. The patient was discharged at the 35th post-operative day in good general conditions. DISCUSSION: This case is about a complex, long-lasting clinical scenario, progressively leading a young woman to death despite several attempts of conservative therapy, sometimes allowed to treat enterocutaneous fistulas. The use of negative pressure therapy to manage open abdomen is still controversial. Patients affected by enterocutaneous fistulas are in need of adequate nutritional support due to their hypercatabolic state, secondary both to the fluid loss and the concomitant inflammatory status. CONCLUSION: When conservative management fails and the patient shows septic complications, a multidisciplinary aggressive approach, including surgery, negative-pressure therapy and hyperbaric oxygen therapy is required to treat this life-threatening condition.
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INTRODUCTION: First- and second-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), such as gefitinib, erlotinib, icotinib, and afatinib are the standard-of-care for first-line therapy of non-small-cell lung cancer (NSCLC) harboring activating EGFR mutations. Unfortunately, after initial activity of an average 9-13 months, disease progression has been reported in the majority of patients. In about 50% of cases the progression is due to the onset of the T790M mutation in exon 20 of the EGFR gene. Third-generation EGFR-TKIs targeting this mutation were investigated, with osimertinib the only reaching clinical practice. Areas covered: A structured search of bibliographic databases for peer-reviewed research literature and of main meetings using a focused review question addressing osimertinib, was undertaken. Expert opinion: Osimertinib is the standard-of-care for EGFR-mutated patients progressing to first-line EGFR-TKIs due to the acquired EGFR T790M mutation. Results from the head-to-head first-line trial comparing osimertinib versus gefitinib or erlotinib in activating EGFR mutations might change the front-line approach. Osimertinib in combination regimens, such as immunotherapy, and in adjuvant setting are ongoing. Thus, the strategic approach for the management of EGFR-mutated NSCLC patients will change further in the next few years.
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Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Piperazinas/farmacocinética , Acrilamidas , Compostos de Anilina , Antineoplásicos/administração & dosagem , Antineoplásicos/farmacocinética , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/patologia , Progressão da Doença , Receptores ErbB/antagonistas & inibidores , Receptores ErbB/genética , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patologia , Mutação , Piperazinas/administração & dosagem , Inibidores de Proteínas Quinases/administração & dosagem , Inibidores de Proteínas Quinases/farmacocinéticaRESUMO
BACKGROUND: Quality of life (QoL) has gained greater importance in the management of metastatic non-small-cell lung cancer due to the palliative nature of treatment. Docetaxel (DCT) and cisplatin (CDDP) doublet has been reported to be associated to a better QoL than the weekly vinorelbine (VNR) and CDDP regimen. Recently a newer more tolerated schedule of the VNR/CDDP regimen has been published and is widely employed in medical practice. The impact of these regimens on patients' QoL as well as symptoms control and type and grading chemo-related side-effects has been compared prospectically. METHODS: Patients received CDDP 75 mg/m(2) plus DCT 75 mg/m(2) on day 1 every weeks (arm A) or CDDP 80 mg/m(2) on day 1 plus VNR 30 mg/m(2) day 1 and 8 every 3 weeks (arm B). G-CSF and/or EPO were employed as needed. Health-related QoL was assessed at entry and after every cycle by the EORTC-QLQ-C30 and LC13 questionnaires, toxicity by the NCI-NCCN CTC vs 2, and intent-to-treat objective response by the Recist criteria. RESULTS: The QoL questionnaires were completed by 37 pts (88%) in the DCT/CDDP arm and 39 pts (87%) in the VNR/CDDP one. Baseline mean scores and rates at which pts failed to complete QoL assessment were similar in the two arms. Global health status of the EORTC QLQ-C30 scale and specific symptoms control (LC13 module) improved during treatment without any statistically significant difference between the two arms. Emotional functioning remained stable in both groups during treatment, whereas physical and role improved slightly. In the DCT/CDDP arm 14 pts (33%; 95%CL 24-40%) had PR, and 10 (24%) SD for a 57% TGCR. In the VNR/CDDP arm 12 pts (27%) achieved PR, 18 (41%) SD a 68% TGCR. Differences were not statistically significant. Median time-to-progression was 4.2 months in the DCT/CDDP arm and 4.5 months in the VNR/CDDP one, and median overall survival was 12.1 (range 1-26+ months) and 12.5 months (range 1-28+ months) for DCT/CDDP and VNR/CDDP arms, respectively. Febrile neutropenia rate was higher in the VNR/CDDP arm (p=0.02) as well as G3-4 anemia (p=0.005) and G-CSF/EPO use (p=0.019). CONCLUSIONS: Global and specific health-related QoL data similar in both treatment groups with no statistically significant difference. Efficacy measures, overall response rate, time-to-progression and overall survival were equivalent in both arms. However, severe anemia and febrile neutropenia are statistically more frequent in the VNR/CDDP arm than in the DCT/CDDP one. These data should be considered in treatment decision-making for pts with advanced non-small-cell lung cancer and for the design of future trials with chemotherapy plus biologics.