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PURPOSE: Anti-programmed cell death protein 1 (PD-1) therapy is a standard of care in recurrent and/or metastatic head and neck squamous cell carcinoma (RMHNSCC). Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI) have immunomodulatory properties and improve clinical outcomes in combination with anti-PD-1 therapy. We report the long-term efficacy and safety of pembrolizumab and cabozantinib and include a correlative biomarker analysis. PATIENTS AND METHODS: This open-label, single-arm, multicenter, phase 2 study screened 50 patients with RMHNSCC, of whom 36 received pembrolizumab and cabozantinib. Primary endpoint was overall response rate (ORR), safety, and tolerability. Secondary endpoints included progression free survival (PFS), overall survival (OS), and correlative studies of tissue and blood. We report the long-term PFS, OS, safety, and describe correlative biomarkers. RESULTS: With median follow-up of 22.4 months, median PFS was 12.8 months 2-year PFS of 32.6% (95%CI 18.8-56.3%) and median OS of 27.7 months,2-year OS of 54.7% (95%CI 38.9-76.8%). Median duration of response was 12.6 months, with 2-year rate of 38.5% (95%CI 30.8-81.8%). Long-term TRAEs included manageable hypothyroidism (5.5%) and grade 1 elevated AST and ALT (2.8%). Baseline tumor p-MET expression correlated with ORR (p=0.0055). Higher density of CD8+, CD103+, and CSF1-R+ cells at baseline correlated with improved OS (hazard ratio [HR]=5.27, p=0.030; HR =8.79, p=0.017; HR =6.87, p=0.040, respectively). CONCLUSION: Pembrolizumab and cabozantinib provided prolonged encouraging long-term disease control and survival with a maintained favorable safety profile. The prognostic significance of increased CD8+, CD103+ and CSF1-R+ cell density in TIME deserve further evaluation in similar clinical settings.
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Background: The aim of this study was to assess whether the frequency and presentation modality of hemorrhoidal prolapse may have an impact on patients' quality of life, leading to a different categorization of patients. Methods: A consecutive series of patients affected by primary hemorrhoidal disease were administered specific questionnaires to assess the severity of symptoms and their quality of life. The frequency/modality of prolapse was also assessed, and the classification of the patients into five categories was hypothesized. The severity of disease was assessed using a validated patient-reported score, while the health-related quality of life was evaluated with the Short Health Scale for hemorrhoidal disease. Results: A total of 122 patients were enrolled. The evaluation of the prolapse modality led to the following classification: type I, 5 patients (4.1%); type II, 9 (7.4%), type IIIa, 48 (39.3%); type IIIb, 52 (42.6%); and type IV, 8 (6.6%). The mean total hemorrhoidal disease score was 9.8 ± 3.3, while the mean total Short Health Scale score was 18.6 ± 5.2. Both scores progressively increased in the five types of prolapse identified, thus showing a worsening of symptoms and quality of life related to the increase in the frequency and modality of prolapse. The assessment of the quality of life showed that all four domains of the Short Health Scale score and the total score were significantly worse in group IIIb compared to IIIa. Conclusions: The frequency and modality of hemorrhoidal prolapse has an impact on the quality of life and allows the identification of new types of patients.
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Prolapso de Órgano Pélvico , Humanos , Femenino , Prolapso de Órgano Pélvico/cirugía , PelvisAsunto(s)
Depresión , Prolapso Rectal , Humanos , Prolapso Rectal/cirugía , Mallas Quirúrgicas , Ansiedad/etiologíaRESUMEN
Traditional fistulotomy is the most performed surgical procedure in anal fistula surgery. We conducted an international online survey to explore colorectal surgeons' opinions and preferences on fistulotomy. Considering the healing and continence impairment rates reported in the literature, surgeons were invited to answer as a hypothetic patient susceptible to being submitted to fistulotomy for low and high anal fistula. A total of 767 surgeons completed the survey from 72 countries. The majority of respondents were consultants, having treated more than 20 anal fistulas in the last year. Most of them declared that anal fistula would be able to negatively affect quality of life and would be worried/anxious about it. Taking into account all aspects, 87.5% and 37.8% of respondents would agree to be treated with a fistulotomy in case of a low and high fistula, respectively, with an acceptance rate that varied worldwide. At multivariate analysis, factors correlated to the acceptance of anal fistulotomy were male gender (p = 0.003), practice of less than 20 fistula operations during last year (p = 0.020), and low fistula (p < 0.001). Surgeons recognized the extreme complexity of this approach. This study highlighted the necessity of an accurate patients' selection and the adoption of alternative strategy to reduce the risk of anal continence impairment.
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Malignant mesothelioma is a rare aggressive tumour of the mesothelium with a propensity to spread locally and, rarely, to distant organs. The latest advances in its diagnosis and treatment have led to an increase in unusual disease presentations. Although a direct invasion of the perineum has been previously described in a men, a malignant mesothelioma spreading to the perianal region was never reported in a women. We presented a rare case of malignant mesothelioma recurrence spreading from the peritoneal cavity to the perineum through the rectovaginal space.
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Mesotelioma Maligno , Mesotelioma , Neoplasias Peritoneales , Masculino , Humanos , Femenino , Mesotelioma/diagnóstico , Mesotelioma/terapia , Mesotelioma/patología , Perineo/patología , Neoplasias Peritoneales/diagnóstico , Neoplasias Peritoneales/cirugía , Neoplasias Peritoneales/patología , Terapia CombinadaRESUMEN
The Emborrhoid is an innovative non-surgical technique for the treatment of severe hemorrhoidal bleeding. Patient selection and the impact on quality of life have not been fully investigated. This prospective observational study aims to evaluate the clinical outcomes after Emborrhoid in patients with high surgical risk. All patients with high surgical risk and anemia due to hemorrhoids were enrolled. Clinical data and previous blood transfusions were collected. The Hemorrhoidal Disease Symptom Score and Short Health Scala were completed before the procedure and during the follow-up visits at 1, 6 and 12 months. Transfusions and serum hemoglobin level variations were registered. Perioperative complications and the recurrence of bleeding were assessed. Trans-radial/femoral embolization of superior rectal artery, and/or middle rectal artery was performed with Interlock and Detachable Embolization Coils. From September 2020 to February 2022, 21 patients underwent a superselective embolization of all branches of the superior rectal artery. The transradial approach was most frequently performed compared to transfemoral access. After the procedure, no signs of ischemia were identified; three minor complications were observed. The mean follow-up was 18.5 ± 6.0 months. At the last follow-up, the mean increase of hemoglobin for patients was 1.2 ± 1.6 g/dL. Three patients needed transfusions during follow-up for recurrent hemorrhoidal bleeding. The Hemorrhoidal Disease Symptom Score and Short Health Scala decreased from 11.1 ± 4.2 to 4.7 ± 4.6 (p < 0.0001) and from 18.8 ± 4.8 to 10.2 ± 4.9 (p < 0.0001), respectively. Patients who had given up on their daily activities due to anemia have returned to their previous lifestyle. Emborrhoid seems to be a safe and effective option for the treatment of bleeding hemorrhoids in frail patients. The low complication rate and the significant reduction of post-defecation bleeding episodes are related to the improvement of the hemorrhoidal symptoms and patients' quality of life.
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BACKGROUND: Implantation of the amniotic membrane and their derivatives can have a beneficial effect on tissue repair and regeneration. We report for the first time the implant of an amniotic membrane in a patient affected by cryptoglandular anal fistula. METHODS: A patch of human amniotic membrane was implanted in a female patient affected by an anterior transphincteric fistula. Following an accurate curettage of the anal fistula, the cryopreserved amniotic membrane was thawed and then washed in the operating room; one side of the membrane was transfixed with a resorbable suture thus creating an implantable fusiform patch. The membrane was subsequently implanted into the fistula tract from the external to the internal opening. The inner and outer parts of the membrane were then sutured to the internal and external fistula openings. RESULTS: No intraoperative or postoperative complications occurred. The patient was discharged one day after the procedure after an uneventful hospitalization. At the 1-week, 1- and 3-month follow-up visits no pain (VAS 0) was referred by the patient and no inflammation was evident at the level of the previous external fistula opening. CONCLUSIONS: The implant of human amniotic membrane in a patient affected by cryptoglandular anal fistula was safely and easily performed. Moreover, future studies to assess the efficacy in the long-term follow-up are needed.
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Avoiding the extensive damage of pelvic structures during ventral rectopexy could minimize secondary disfunctions. The objective of our observational study is to assess the safety and functional efficacy of a modified ventral rectopexy. In the modified ventral rectopexy, a retroperitoneal tunnel was created along the right side of rectum, connecting two peritoneal mini-incisions at the Douglas pouch and sacral promontory. The proximal edge of a polypropylene mesh, sutured over the ventral rectum, was pulled up through the retroperitoneal tunnel and fixed to the sacral promontory. In all patients, radiopaque clips were placed on the mesh, making it radiographically "visible". Before surgery and at follow up visits, Altomare, Longo, CCSS, PAC-SYM, and CCFI scores were collected. From March 2010 to September 2021, 117 patients underwent VR. Modified ventral rectopexy was performed in 65 patients, while the standard ventral rectopexy was performed in 52 patients. The open approach was used in 97 cases (55 and 42 patients in modified and standard VR, respectively), while MI surgery was used in 20 cases (10 and 10 patients in modified and standard VR, respectively). A slightly shorter operative time and hospital stay were observed following modified ventral rectopexy (though this was not statistically significant). Similar overall complication rates were registered in the modified vs. standard ventral rectopexies (4.6% vs. 5.8%, p = 0.779). At follow-up, the Longo score (14.0 ± 8.6 vs. 11.0 ± 8.2, p = 0.042) and "delta" values of Altomare (9.2 ± 6.1 vs. 5.9 ± 6.3, p = 0.008) and CCSS (8.4 ± 6.3 vs. 6.1 ± 6.1, p = 0.037) scores were significantly improved in the modified ventral rectopexy group. A similar occurrence of symptoms recurrence was diagnosed in the two groups. Radiopaque clips helped to accurately diagnose mesh detachment/dislocation. The proposed modified VR seems to be feasible and safe. Marking the mesh intraoperatively seems useful.
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PURPOSE: To determine whether outpatient transradial emborrhoid technique can be performed safely and effectively in the treatment of symptomatic hemorrhoids. MATERIALS AND METHODS: The transradial emborrhoid technique was used to treat 12 patients with symptomatic hemorrhoids in an outpatient setting during a 4-month period. After percutaneous catheterization of the left radial artery, a 5-Fr sheath was introduced to catheterize the inferior mesenteric artery and a microcatheter was advanced into the branches of the superior rectal artery for embolization with 0.018-inch detachable coils (Interlock and IDC-interlocking detachable coils). After embolization, the sheath was withdrawn and puncture site hemostasis was achieved using a wrist band. All patients were evaluated 6 h after the procedure to determine whether they meet the discharge criteria and were discharged the following day. The results of the emborrhoid treatment were assessed at the 4-week follow-up. RESULTS: The emborrhoid technique was successful in all patients. There was no major complication associated with the procedure. All patients met the discharge criteria 6 h after the procedure. Reduction of local edema and of hemorrhoidal congestion was observed in all patients. At the follow-up visit, the mean Rorvik score (HDSS + SHS-HD) decreased from 31.50 (7.50) to 13.11 (8.33) (p < .001). CONCLUSIONS: Transradial rectal artery embolization is a safe and effective treatment option for patients with chronic symptoms of hemorrhoid disease.
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Embolización Terapéutica/métodos , Hemorroides/terapia , Pacientes Ambulatorios , Anciano , Femenino , Humanos , Masculino , Proyectos Piloto , Estudios Prospectivos , Recto/irrigación sanguínea , Resultado del TratamientoRESUMEN
The aims of this study were to evaluate the efficacy of two different phlebotonic therapies, preoperatively administered in advanced hemorrhoidal disease (HD) patients with recommendation for surgery, and to assess patient satisfaction after treatment. In this prospective observational study, 100 patients were preoperatively treated either with micronized purified flavonoid fraction (group A) or sublingual nano-emulsion flavonoid (group B). HD symptoms, local inflammation signs and patients' satisfaction were evaluated at baseline visit (T0), after 4 weeks of therapy (T1) and 8 weeks after its discontinuation (T2). In group A, a significant improvement for all HD symptoms and inflammation signs was observed after therapy (T1), followed by a reduction of efficacy in T2, except for itching and edema. In group B, therapy had a significant benefit on symptoms and local inflammation at T1, which persisted after its discontinuation for all symptoms, and edematous hemorrhoids. In both groups, the satisfaction rate was "good" in 60% of patients and patients were statistically significant more satisfied at T1 compared with T2 (p = 0.0001). No adverse events were recorded. Preoperative treatment was safe and useful to optimize patients' clinical condition prior to surgery.
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BACKGROUND: External anal sphincter contractility significantly contributes to control the passage of stool. An artificial anal sphincter placed into the intersphincteric space is a safe and effective procedure to treat fecal incontinence, even if its mechanism of action has not been fully elucidated. OBJECTIVE: The aim of this study was to evaluate external anal sphincter contractility changes after a self-expandable hyexpan prostheses was implanted into the intersphincteric space of the anal canal and clinical outcomes compared. DESIGN: This was a prospective clinical study. SETTINGS: The study was conducted at a university teaching hospital. PATIENTS: Consecutive patients affected by fecal incontinence for at least 6 months after failure of conservative treatment were included. INTERVENTIONS: All of the patients underwent 10-prostheses implantation and were examined preoperatively and postoperatively by endoanal ultrasound and anorectal manometry. MAIN OUTCOME MEASURES: Fecal incontinence symptoms were assessed by severity scores. The external anal sphincter muscle tension was calculated using a specific equation. RESULTS: Thirty-nine patients (34 women; median age = 68 y) were included in the study; no morbidity was registered. After a median follow-up period of 14 months, both the median maximum voluntary squeeze pressure and the median inner radius of the external anal sphincter significantly increased. A statistically significant increase of external anal sphincter muscle tension was detected. A decrease of any fecal incontinence symptom and an improvement in severity scores were observed at the last follow-up examination. The external anal sphincter contractility was significantly higher in patients reducing incontinence episodes to solid stool by >50% and improving their ability to defer defecation for >15 minutes. LIMITATIONS: This was a single-center experience with a relatively small and heterogeneous sample size, patients with a potentially more severe disease because our institution is a referral center, and an absence of quality-of-life evaluation. CONCLUSIONS: Artificial anal sphincter implantation improved the external anal sphincter muscle tension; there was a positive correlation between its increase and the clinical outcome. See Video Abstract at http://links.lww.com/DCR/B468. IMPLANTE DE ESFNTER ANAL ARTIFICIAL AUTOEXPANDIBLE EN PACIENTES CON INCONTINENCIA FECAL MEJORA LA CONTRACTILIDAD DEL ESFNTER ANAL EXTERNO: ANTECEDENTES:La contractilidad del esfínter anal externo contribuye significativamente al control del paso de las heces. Un esfínter anal artificial colocado en el espacio interesfinteriano es un procedimiento seguro y eficaz para tratar la incontinencia fecal, incluso si su mecanismo de acción no se ha definido por completo.OBJETIVO:El objetivo de este estudio fue evaluar los cambios en la contractilidad del esfínter anal externo después de la implantación de una prótesis de hyexpan autoexpandible en el espacio interesfinteriano del canal anal y comparar los resultados clínicos.DISEÑO:Estudio clínico prospectivo.ENTORNO CLINICO:El estudio se realizó en un hospital universitario.PACIENTES:Pacientes consecutivos afectados por incontinencia fecal durante al menos 6 meses, tras fracaso de tratamiento conservador.INTERVENCIONES:Todos los pacientes fueron sometidos a la implantación de 10 prótesis, y fueron examinados pre y postoperatoriamente mediante ecografía endoanal y manometría anorrectal.PRINCIPALES MEDIDAS DE VALORACION:Los síntomas de incontinencia fecal se evaluaron mediante puntuaciones de gravedad. La tensión del músculo del esfínter anal externo se calculó mediante una formula específica.RESULTADOS:Treinta y nueve pacientes (34 mujeres; mediana de edad 68 años) fueron incluidos en el estudio; no se registró morbilidad. Después de un período de seguimiento medio de 14 meses, tanto la presión de compresión voluntaria máxima media como el radio interior medio del esfínter anal externo aumentaron significativamente. Se detectó un aumento estadísticamente significativo de la tensión del músculo del esfínter anal externo. En el último examen de seguimiento se observó una disminución de cualquier síntoma de incontinencia fecal y una mejora en las puntuaciones de gravedad. La contractilidad del esfínter anal externo fue significativamente mayor en los pacientes que redujeron los episodios de incontinencia a heces sólidas en más del 50% y mejoraron la capacidad para diferir la defecación durante más de 15 minutos.LIMITACIONES:Experiencia de un solo centro; tamaño de muestra relativamente pequeño y heterogéneo; pacientes con una enfermedad potencialmente más grave porque nuestra institución es un centro de referencia; ausencia de evaluación de la calidad de vida.CONCLUSIONES:La implantación del esfínter anal artificial mejoró la tensión muscular del esfínter anal externo; hubo una correlación positiva entre su aumento y el resultado clínico. Consulte Video Resumen en http://links.lww.com/DCR/B468.
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Canal Anal/cirugía , Incontinencia Fecal/prevención & control , Tono Muscular/fisiología , Prótesis e Implantes/efectos adversos , Implantación de Prótesis/instrumentación , Anciano , Canal Anal/fisiopatología , Defecación/fisiología , Endosonografía/métodos , Incontinencia Fecal/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Manometría/métodos , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis/tendencias , Implantación de Prótesis/métodos , Seguridad , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Several minimally invasive surgical procedures have been recently developed to treat hemorrhoids without any excision. About 25 years ago, a non-excisional procedure providing doppler- guided ligation of the hemorrhoidal arteries has been proposed - named "hemorrhoidal dearterialization". The original technique has been modified over the years, and indications were expanded. In particular, a plication of the redundant and prolapsing mucosa/submucosa of the rectum (named "mucopexy") has been introduced to treat hemorrhoidal prolapse, without excision of the hemorrhoidal piles. At present, the THD® Doppler procedure is one of the most used techniques to treat hemorrhoids. Aim of this technique is to realize a target dearterialization, using a Doppler probe with the final purpose to reduce the arterial overflow to the hemorrhoidal piles. In the case of associated hemorrhoidal prolapse, a mucopexy is performed together with Doppler-guided dearterialization. The entity and circumferential extension of the hemorrhoidal prolapse guide the mucopexy, which can be considered tailored to a single patient; the dearterialization should be considered mandatory. Advantages of this surgical technique are the absence of serious and life-threatening postoperative events, chronic complications, and limited recurrence risks. The impact of the procedure on the anorectal physiology is negligible. However, careful postoperative management is mandatory to avoid complications and to guarantee an improved long-term outcome. Therefore, regular physiologic bowel movements, excessive strain at the defecation and strong physical activity are advisable.
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Hemorroides , Hemorroides/diagnóstico por imagen , Hemorroides/cirugía , Humanos , Ligadura , Recto/diagnóstico por imagen , Recto/cirugía , Resultado del Tratamiento , Ultrasonografía DopplerRESUMEN
Surgery of mid-to-low rectal cancer is still considered challenging. Transanal total mesorectal excision has been proposed to facilitate the mesorectal dissection, gain sphincter-saving procedures, and reduce functional sequelae. Few studies have investigated long-term functional outcomes and patients' quality of life. The aim of this study was to compare functional outcomes and quality of life before and after transanal total mesorectal excision in 1-year follow-up. Between February 2016 and April 2019, 51 patients with mid- or low rectal cancer undergoing transanal total mesorectal excision at Fondazione Policlinico Universitario "A. Gemelli" were enrolled. Neoadjuvant radiochemotherapy was administered to locally advanced cancers. Before and after the surgical procedure, patients were examined collecting clinical data, LARS score, CCFIS, SF36 and FIQL, performing anorectal manometry and endoanal ultrasonography. Thirty-three patients were eligible and completed the 12 months follow-up. After treatment, six patients (18.2%) had minor or major LARS. A mild but significant increase of CCFIS was documented. Only the mean resting pressure significantly decreased at follow-up. No sphincter lesions were documented. FIQL assessment showed significant reduction of lifestyle, coping/behaviour, and embarrassment, while an increase of general health was assessed by SF36. At both uni- and multivariate analyses the neoadjuvant radiochemotherapy had a not negligible impact. Transanal total mesorectal excision represents a safe approach to patients treated for mid- or low rectal cancer. The functional sequelae can be limited in severity, with a low incidence of minor/major LARS, particularly faecal incontinence. These results are comparable to those obtained by the conventional total mesorectal excision.
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Canal Anal/fisiopatología , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Tratamientos Conservadores del Órgano/métodos , Calidad de Vida , Recuperación de la Función , Neoplasias del Recto/fisiopatología , Neoplasias del Recto/cirugía , Recto/fisiopatología , Anciano , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Incontinencia Fecal/etiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante , Complicaciones Posoperatorias/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
The aims of this population study were to assess the lockdown impact on patients waiting for hemorrhoidal surgery, and the role of telemedicine in patient management. All patients on our waiting list for hemorrhoidal surgery were considered. Eligible patients were contacted by phone. Rørvik score was evaluated and compared to the baseline score. Univariate and multivariate analyses were performed. A numeric rating scale was used to estimate patient satisfaction regarding telemedicine. One-hundred and ten patients were found to be eligible. Finally, 103 patients were included in the study of whom 16 (15.3%) were already considered for priority surgery. Patients waiting for a longer time showed significantly worse scores (p < 0.001). After telemedicine evaluation the priority waiting list increased by 43.8% (plus 23 patients). Weight loss of at least 3 kg and physical activity were found to be protective factors (p = 0.02 and p = 0.002 respectively). A high grade of satisfaction (almost 80%) towards telemedicine was registered. COVID-19-related delays are linked to a deterioration of hemorrhoidal symptoms and patients' well-being. Weight and lifestyle changes were deemed key factors in determining disease severity. Telemedicine was a valuable tool to evaluate and re-evaluate patients waiting for hemorrhoidal surgery and was considered satisfactory by patients.
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Central cord syndrome (CCS) represents a clinical phenomenon characterized by disproportionately greater motor impairment of the upper than of the lower extremities, bladder dysfunction. CSS is the most common form of incomplete traumatic spinal cord injury. The initial description of CSS was reported in 1887 secondary to cervical spinal trauma. However, recent literature describes a heterogenous injury patterns including high-energy and low-energy mechanisms and bimodal patient age distributions. Pathophysiology of clinical symptoms and neurological deficits often is affected by preexisting cervical spondylosis. Urgent clinical diagnosis is dependent on neurological examination and imaging studies. Treatment of CSS is dependent on injury mechanism and compressive lesions, neurological examination, preexisting cervical pathology, and patient-specific comorbidities. This article will review the current concepts in diagnosis, pathophysiology, and treatment of CSS with a highlighted case example.
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Síndrome del Cordón Central/diagnóstico , Vértebras Cervicales/lesiones , Traumatismos de la Médula Espinal/diagnóstico , Espondilosis , Accidentes por Caídas , Anciano , Envejecimiento , Síndrome del Cordón Central/complicaciones , Síndrome del Cordón Central/diagnóstico por imagen , Síndrome del Cordón Central/cirugía , Vértebras Cervicales/cirugía , Diagnóstico Diferencial , Humanos , Masculino , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/diagnóstico por imagen , Traumatismos de la Médula Espinal/cirugíaRESUMEN
á .