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BACKGROUND: Conflicting data persists for use of wound protectors in pancreatoduodenectomy (PD) to prevent surgical site infection (SSI). We aimed to examine, at a multi-institutional level, the effect of wound protectors on superficial or deep SSI following elective open PD. METHODS: The American College of Surgeons National Surgical Quality Improvement Program pancreatectomy procedure targeted participant use file was queried from 2016 to 2018. Planned open PD procedures were extracted. Univariable, multivariable, and propensity score matched analyses were conducted. RESULTS: 11,562 patients undergoing PD were evaluated, 27% of which used wound protectors. Wound protectors decreased superficial or deep SSI risk in all patients (5.7% vs. 9.5%, P < 0.001), patients who have (6.6% vs. 12.2%, P < 0.001) and who did not have (4.6% vs. 6.5%, P = 0.011) a biliary stent. Propensity score matched analysis confirms such results (OR = 0.56, 95% CI: 0.46-0.69, P < 0.001 overall, OR = 0.66, 95% CI: 0.46-0.95, P = 0.03 without biliary stent, OR = 0.57, 95% CI: 0.44-0.73, P < 0.001 with biliary stent). CONCLUSIONS: Wound protectors reduce risk of superficial or deep SSI in patients undergoing PD, yet only a quarter of PD were associated with their use. This protective effect is seen whether patients have or have not had preoperative biliary stenting.
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Procedimientos Quirúrgicos del Sistema Biliar , Infección de la Herida Quirúrgica , Procedimientos Quirúrgicos Electivos , Humanos , Pancreaticoduodenectomía/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/prevención & controlRESUMEN
BACKGROUND: The management of patients with synchronous colorectal liver metastases (sCRLM) has evolved significantly (improved chemotherapy, hepatic surgery advancements, colonic stenting, consultation synergies). We sought to better understand surgeon viewpoints on optimal referral patterns and the delivery of simultaneous resections. METHODS: A 40 question on-line survey was offered to members of the Canadian surgical community. Statistical analysis was descriptive. RESULTS: A total of 52 surgeons responded. Most colorectal surgeons (CRS) had access to and a good working relationship with regional hepatobiliary (HPB) surgeons (86%) and medical oncologists (100%). The majority (92%) believed there was a role for simultaneous resection of sCRLM, with 69% having first hand experience. Many CRS (62%) discussed all cases of known hepatic metastases with HPB prior to any resection. When a lesion was asymptomatic/minimally symptomatic, most CRS (92%) discussed them with medical oncology/HPB prior to resection (8%). Bilobar metastases (58%), patient comorbidities (35%), portal lymphadenopathy (35%), and patient age (15%) restricted CRS from obtaining HPB consultations. Many CRS (46%) did not believe that resecting hepatic metastases prior to the primary lesion might be beneficial. Most CRS (60%) reported they could not accurately predict hepatic resectability, with only 27% familiarity with evidence-based guidelines. Despite working in smaller hospitals with less access to HPB and less experience with simultaneous resections, non-CR general surgeons more commonly supported a 'liver-first' approach. CONCLUSIONS: There was general agreement between CRS and general surgeons on numerous topics, but additional education is required with regard to HPB surgical capabilities and to provide truly individualized patient-centered care.
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OBJECTIVE: To evaluate the efficacy of a dual-ring wound protector for preventing incisional surgical site infection (SSI) among patients with preoperative biliary stents undergoing pancreaticoduodenectomy (PD). METHODS AND ANALYSIS: This study was a parallel, dual-arm, double-blind randomized controlled trial. Adult patients with a biliary stent undergoing elective PD at 2 tertiary care institutions were included (February 2013 to May 2016). Patients were randomly assigned to receive a surgical dual-ring wound protector or no wound protector, and also the current standard of care. The main outcome measure was incisional SSI, as defined by the Centers for Disease Control and Prevention criteria, within 30 days of the index operation. RESULTS: A total of 107 patients were recruited (mean age 67.2 years; standard deviation 12.9; 65% male). No significant differences were identified between the intervention and control groups (age, sex, body mass index, preoperative comorbidities, American Society of Anesthesiologists class, prestent cholangitis). There was a significant reduction in the incidence of incisional SSI in the wound protector group (21.1% vs 44.0%; relative risk reduction 52%; P = 0.010). Patients with completed PD also displayed a decrease in incisional SSI with use of the wound protector compared with those palliated surgically (27.3% vs 48.7%; P = 0.04). Multivariate analysis did not identify any significant modifying factor relationships (estimated blood loss, duration of surgery, hospital site, etc.) (P > 0.05). CONCLUSION: Among adult patients with intrabiliary stents, the use of a dual-ring wound protector during PD significantly reduces the risk of incisional SSI.
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Pancreaticoduodenectomía/instrumentación , Stents , Infección de la Herida Quirúrgica/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Incidencia , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Análisis Multivariante , Pancreaticoduodenectomía/métodos , Estudios Prospectivos , Factores de Riesgo , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología , Resultado del Tratamiento , Adulto JovenRESUMEN
SUMMARY: Over the last 3 decades, expansion in the scope and complexity of hepatopancreatobiliary (HPB) surgery has resulted in significant improvements in postoperative outcomes. As a result, the importance of dedicated fellowship training for HPB surgery is now well established, and the definition of formal program requirements has been actively pursued by a collaboration of the 3 distinct accrediting bodies within North America. While major advances have been made in defining minimum case volume requirements, qualitative assessment of the operative experience remains challenging. Our research collaborative (HPB Manpower and Education Study Group) has previously explored the perceived case volume adequacy of core HPB procedures within fellowship programs. We conducted a 1-year follow-up survey targeting the same cohort to investigate the association between operative case volumes and comfort performing HPB procedures within initial independent practice.
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Curriculum , Procedimientos Quirúrgicos del Sistema Digestivo/educación , Internado y Residencia/organización & administración , Procedimientos Quirúrgicos del Sistema Biliar/educación , Procedimientos Quirúrgicos del Sistema Biliar/estadística & datos numéricos , Procedimientos Quirúrgicos del Sistema Digestivo/estadística & datos numéricos , Encuestas de Atención de la Salud , Humanos , Internado y Residencia/estadística & datos numéricosRESUMEN
OBJECTIVES: To predict variation in thoracic surgery workforce requirements with the introduction of stereotactic ablative radiotherapy (SABR) for the treatment of early-stage non-small-cell lung cancer (NSCLC). METHODS: Using Canadian census microdata and the Canadian Community Health Survey, a microsimulation model representing the national population was developed. The demand component simulates the incidence of lung cancer, incorporating the impact of computed tomography (CT) screening for high-risk individuals (>30 pack-year smoking history; age 55-74 years). The supply component simulates the number of thoracic surgeons. SABR was introduced into the model to predict changes in the number of operable NSCLC cases per thoracic surgeon, modelling 30, 60 and 90% compliance with SABR for Stage IA and then for both Stage IA and IB NSCLC. RESULTS: In the absence of SABR, the volume of operative NSCLC per surgeon increases by a peak of 49.4% (by 2027) and then gradually declines to the present day volume by 2049. More dramatic decreases are seen with increasing compliance with SABR for Stage IA/IB NSCLCs. If the number of new surgeons entering the workforce per year were reduced by 33%, the operative volume per surgeon would increase by a peak of 57.1% (30% Stage IA SABR compliance) and would decrease by up to 49.1% (90% Stage IA SABR compliance). CONCLUSIONS: With the implementation of SABR for treatment of early NSCLC, there would be a decrease in operative volume. The impact would depend on the stage of NSCLC for which SABR is recommended and on compliance. A national strategy for thoracic surgery workforce planning is necessary, given the complex interaction of CT screening and the treatment of medically operable early NSCLC with SABR.
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Carcinoma de Pulmón de Células no Pequeñas/radioterapia , Neoplasias Pulmonares/radioterapia , Radiocirugia/métodos , Cirugía Torácica , Anciano , Canadá/epidemiología , Carcinoma de Pulmón de Células no Pequeñas/diagnóstico por imagen , Carcinoma de Pulmón de Células no Pequeñas/epidemiología , Carcinoma de Pulmón de Células no Pequeñas/patología , Humanos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/patología , Persona de Mediana Edad , Modelos Teóricos , Estadificación de Neoplasias , Prevención Secundaria/métodos , Cirujanos/estadística & datos numéricos , Cirugía Torácica/tendencias , Tomografía Computarizada por Rayos X , Recursos Humanos , Carga de Trabajo/estadística & datos numéricosRESUMEN
OBJECTIVES: To evaluate the quality of reporting of randomized controlled trials (RCTs) in the thoracic surgery literature according to Consolidated Standard for Reporting of Trials (CONSORT) and to determine predictors of quality. METHODS: All RCTs published in four principal journals between 1998 and 2013 were identified in PubMed. Two independent reviewers assessed each trial using the CONSORT checklist (1996) with discrepancies resolved by a third reviewer. Mean checklist scores were compared between trials published from 1998 to 2005 and 2006 to 2013. The κ statistic for inter-rater agreement was calculated. Stepwise multivariable linear regression was then performed to identify independent predictors of quality. RESULTS: After 2 rounds of review, 203 of the 2838 identified articles met inclusion criteria. The overall κ coefficient was 0.95 indicating very good agreement between reviewers. The mean CONSORT score was significantly higher in 2006-13 [mean 10.8; 95% confidence interval (CI): 10.3-11.2] than in 1998-2005 (mean 9.3; 95% CI: 8.7-9.6). On multivariable analysis, there was strong evidence of an increased mean CONSORT score in studies comparing non-surgical interventions, multicentre trials, publications after 2006, studies with increased number of authors and studies funded by industries. CONCLUSIONS: Our study suggests that the quality of reporting in the thoracic surgery literature is improving with time and is predicted by factors including number of authors, multicentre trials, type of comparison, time period of publication and industry sponsorship. Ongoing efforts should be made to improve the quality of reporting in thoracic surgery.
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Publicaciones/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Procedimientos Quirúrgicos Torácicos , Investigación Biomédica , Humanos , Modelos Lineales , Publicaciones/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Estudios RetrospectivosRESUMEN
BACKGROUND: A minimally invasive approach to lung cancer resection offers many benefits over traditional open surgery. Reasons for increased difficulty and conversion from thoracoscopic to open surgery have been studied and include abnormal hilar or interlobar lymphadenopathy. METHODS: We present a case of adherent lymphadenopathy complicating dissection of the truncus anterior branch of the pulmonary artery during thoracoscopic left upper lobectomy. RESULTS: We show one approach to the management of difficult lymphadenopathy and pulmonary arterial isolation, that of division without closure of the lobar bronchus to allow superior access to the branches of the pulmonary artery, followed by stapled closure of the bronchus. CONCLUSIONS: While adherent lymphadenopathy is a vexing problem in thoracoscopic lobectomy, minimallyinvasive approaches are safe and effective. We show that division of the bronchus can improve exposure and allow safe dissection to proceed.
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BACKGROUND: A minimally invasive approach to lung cancer resection offers many benefits over traditional open surgery. Pulmonary arterial injury is a widely cited reason for conversion to open surgery. METHODS: We present a case of pulmonary arterial injury complicating dissection of the pulmonary artery during thoracoscopic left upper lobectomy. Ethical approval was obtained from the institutional ethics board and written consent was obtained from the patient. RESULTS: Thoracoscopic management of pulmonary arterial bleeding is demonstrated. We show maintenance of a thoracoscopic approach with establishment of proximal pulmonary arterial control, allowing suture repair of an injury to the ongoing pulmonary artery. CONCLUSIONS: While pulmonary arterial injury may be a significant problem during thoracoscopic lobectomy, minimally invasive approaches to repair are safe and effective.
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BACKGROUND: Hepatopancreatobiliary fellowship programmes have recently undergone significant changes with regards to training standards, case-volume thresholds and multimodality educational platforms. The goals of this study were to compare the perspectives of fellows and programme directors (PDs) on perceptions of readiness to enter practice and identify core Hepato-Pancreato-Biliary (HPB) procedures that require increased emphasis during training. METHODS: This survey targeted PDs and trainees participating in the Fellowship Council/AHPBA pathway. Data related to demographics, education and career plans were collected. Analysis of PD and fellow opinions regarding their confidence to perform core HPB procedures was completed. RESULTS: The response rate was 88% for both fellows (21/24) and PDs (23/26). There was good agreement between PDs and fellows in the perception of case volumes. Select differences where PDs ranked higher perceptions included major hepatectomies (PDs: 87% versus fellows: 57%, P = 0.04), pancreaticoduodenectomies (100% versus 81%, P = 0.04) and laparoscopic distal pancreatectomies (78% versus 43%, P = 0.03). 'Good or excellent' case volumes translated into increased fellow readiness, except for some pancreatitis procedures, laparoscopic distal pancreatectomies and potentially major hepatectomies. CONCLUSIONS: This study provides insight into content domains that may require additional attention to achieve an appropriate level of proficiency and confidence upon completion of training.
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Enfermedades de las Vías Biliares/cirugía , Competencia Clínica , Curriculum , Educación de Postgrado en Medicina/normas , Gastroenterología/educación , Internado y Residencia/normas , Hepatopatías/cirugía , Enfermedades Pancreáticas/cirugía , Desarrollo de Programa , Adulto , Femenino , Humanos , Masculino , Estados UnidosRESUMEN
This article characterizes the Canadian hepato-pancreato-biliary (HPB) surgery workforce (demographics, practice patterns, career satisfaction, education and recruitment plans). This information will serve as a baseline for future national comparisons, allow informed workforce planning and facilitate mathematical modelling of the HPB workforce in Canada.
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Gastroenterología , Especialidades Quirúrgicas , Adulto , Canadá , Estudios Transversales , Recolección de Datos , Procedimientos Quirúrgicos del Sistema Digestivo/educación , Educación de Postgrado en Medicina/estadística & datos numéricos , Femenino , Gastroenterología/educación , Humanos , Satisfacción en el Trabajo , Masculino , Persona de Mediana Edad , Selección de Personal , Pautas de la Práctica en Medicina/estadística & datos numéricos , Especialidades Quirúrgicas/educación , Recursos HumanosRESUMEN
To understand the challenges of screening for lung cancer, surgeons should be familiar with fundamental epidemiologic concepts pertaining to screening and have an understanding of the evidence regarding the various modalities used for screening lung cancer. One large, recent study has confirmed that screening for lung cancer with low-dose computed tomography decreases mortality in high-risk individuals. As a result of these findings, comprehensive screening programs are being developed. High-quality programs should be safe, cost-effective, accessible to high-risk patients, and involve the participation of a multidisciplinary team. Surgeons should be engaged in the implementation of screening programs for lung cancer.
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Detección Precoz del Cáncer/métodos , Neoplasias Pulmonares/diagnóstico , Tamizaje Masivo/métodos , Cirujanos , Tomografía Computarizada por Rayos X , Anciano , Análisis Costo-Beneficio , Reacciones Falso Positivas , Humanos , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/cirugía , Persona de Mediana Edad , Dosis de Radiación , Radiografía Torácica , Reproducibilidad de los Resultados , Riesgo , Esputo/citologíaRESUMEN
INTRODUCTION: Among surgical oncology patients, incisional surgical site infection is associated with substantially increased morbidity, mortality and healthcare costs. Moreover, while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection, and wound protectors may significantly reduce its risk, no relevant studies of wound protectors yet exist involving this patient population. This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents. METHODS AND ANALYSIS: This study will be a parallel, dual-arm, randomised controlled trial that will utilise a more explanatory than pragmatic attitude. All adults (≥18â years) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary, Alberta, Canada with preoperative placement of an intrabiliary stent will be considered eligible. Exclusion criteria will include patient age <18â years and those receiving long-term glucocorticoids. The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector (the Alexis Wound Protector) or no wound protector and the current standard of care. The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30â days of the index operation date as determined by a research assistant blinded to treatment allocation. Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95% CIs and compared using Fisher's exact test. ETHICS AND DISSEMINATION: This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy. Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT01836237.
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Neoplasias Pancreáticas/cirugía , Pancreaticoduodenectomía/métodos , Cuidados Preoperatorios , Stents , Instrumentos Quirúrgicos , Infección de la Herida Quirúrgica/prevención & control , Humanos , Pancreaticoduodenectomía/instrumentaciónRESUMEN
BACKGROUND: This study aimed to predict variation in the thoracic surgery workforce requirements with the introduction of a national chest computed tomographic (CT) screening program for individuals at high risk of lung cancer. METHODS: Using Canadian census microdata and the Canadian Community Health Survey, a microsimulation model representing the national population was developed. The demand component simulates the incidence of lung cancer, whereas the supply component simulates the number of practicing thoracic surgeons. A national CT screening program in high-risk individuals (>30 pack-year history of smoking; age, 55-74 years) was introduced into the model to predict changes in the number of operable lung cancers per thoracic surgeon. RESULTS: From 2013 to 2040, the Canadian population increased from 34 to 43 million. The number eligible for screening varies from 1,112,800 (2013) to 513,200 (2040), peaking at 1,147,700 (2017). Comparing CT screening with chest radiography, overall lung cancer diagnoses increase 7.3% by 2040, with stage 1A increasing by 15.6% and stage IV decreasing by 7.5%. The rate of operable early lung cancers per thoracic surgeon increases by 24.2% (2020), 19.8% (2030), and 16% (2040), with CT screening relative to the baseline increase seen with chest radiography. CONCLUSIONS: With the implementation of a CT screening program there will be an increase in operable lung cancers, resulting in increased surgical volume. A national strategy for the thoracic surgery workforce is necessary to ensure that an appropriate number of surgeons are being trained to meet the future needs of the national population.
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Detección Precoz del Cáncer/métodos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/epidemiología , Modelos Estadísticos , Cirugía Torácica , Tomografía Computarizada por Rayos X , Anciano , Predicción , Humanos , Incidencia , Persona de Mediana Edad , Factores de Tiempo , Recursos HumanosRESUMEN
OBJECTIVE: To develop a microsimulation model of thoracic surgery workforce supply and demand to forecast future labor requirements. METHODS: The Canadian Community Health Survey and Canadian Census data were used to develop a microsimulation model. The demand component simulated the incidence of lung cancer; the supply component simulated the number of practicing thoracic surgeons. The full model predicted the rate of operable lung cancers per surgeon according to varying numbers of graduates per year. RESULTS: From 2011 to 2030, the Canadian national population will increase by 10 million. The lung cancer incidence rates will increase until 2030, then plateau and decline. The rate will vary by region (12.5% in Western Canada, 37.2% in Eastern Canada) and will be less pronounced in major cities (10.3%). Minor fluctuations in the yearly thoracic surgery graduation rates (range, 4-8) will dramatically affect the future number of practicing surgeons (range, 116-215). The rate of operable lung cancer varies from 35.0 to 64.9 cases per surgeon annually. Training 8 surgeons annually would maintain the current rate of operable lung cancer cases per surgeon per year (range, 32-36). However, this increased rate of training will outpace the lung cancer incidence after 2030. CONCLUSIONS: At the current rate of training, the incidence of operable lung cancer will increase until 2030 and then plateau and decline. The increase will outstrip the supply of thoracic surgeons, but the decline after 2030 will translate into an excess future supply. Minor increases in the rate of training in response to short-term needs could be problematic in the longer term. Unregulated workforce changes should, therefore, be approached with care.
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Predicción , Fuerza Laboral en Salud/tendencias , Neoplasias Pulmonares/cirugía , Médicos/provisión & distribución , Médicos/tendencias , Cirugía Torácica/tendencias , Procedimientos Quirúrgicos Torácicos/tendencias , Canadá/epidemiología , Simulación por Computador , Educación de Postgrado en Medicina/tendencias , Humanos , Incidencia , Internado y Residencia/tendencias , Neoplasias Pulmonares/epidemiología , Modelos Teóricos , Cirugía Torácica/educación , Procedimientos Quirúrgicos Torácicos/educación , Factores de TiempoRESUMEN
OBJECTIVE: To identify core thoracic surgery procedures that require increased emphasis during thoracic surgery residency for residents to achieve operative independence and to compare the perspectives of residents and program directors in this regard. METHODS: A modified Delphi process was used to create a survey that was distributed electronically to all Canadian thoracic surgery residents (12) and program directors (8) addressing the residents' ability to perform 19 core thoracic surgery procedures independently after the completion of residency. Residents were also questioned about the adequacy of their operative exposure to these 19 procedures during their residency training. A descriptive summary including calculations of frequencies and proportions was conducted. The perceptions of the 2 groups were then compared using the Fisher exact test employing a Bonferroni correction. The relationship between residents' operative exposure and their perceived operative ability was explored in the same fashion. RESULTS: The response rate was 100% for residents and program directors. No statistical differences were found between residents' and program directors' perceptions of residents' ability to perform the 19 core procedures independently. Both groups identified lung transplantation, first rib resection, and extrapleural pneumonectomy as procedures for which residents were not adequately prepared to perform independently. Residents' subjective ratings of operative exposure were in good agreement with their reported operative ability for 13 of 19 procedures. CONCLUSION: This study provides new insight into the perceptions of thoracic surgery residents and their program directors regarding operative ability. This study points to good agreement between residents and program directors regarding residents' surgical capabilities. This study provides information regarding potential weaknesses in thoracic surgery training, which may warrant an examination of the curricula of existing programs as well as a reconsideration of what the scope of practice of a general thoracic surgeon should entail.
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Personal Administrativo , Cirugía Torácica/educación , Actitud del Personal de Salud , Canadá , Recolección de Datos , Evaluación de Programas y Proyectos de Salud/métodos , Procedimientos Quirúrgicos Torácicos/normasRESUMEN
INTRODUCTION: Cavernous hemangiomas of the adrenal gland are rare. We report a case of a cavernous hemangioma of the adrenal gland presenting as an adrenal incidentaloma suspicious for adrenal cortical carcinoma (ACC). PRESENTATION OF CASE: A 78 year old woman was admitted after a fall. Abdominal computed tomography revealed a large right adrenal lesion with features suspicious for adrenal cortical carcinoma (5.4cm×3.3cm, unilateral, tumor calcifications, average Hounsfield units 55). The tumor was removed intact by a laparoscopic approach and pathology revealed a cavernous hemangioma of the adrenal gland. DISCUSSION: Adrenal incidentalomas are found in up to 10% of patients undergoing abdominal imaging. Differential diagnosis includes both benign and malignant lesions. Guidelines for removal of adrenal incidentalomas recommend surgery based on functional status, size, and presence of concerning features on diagnostic imaging. Cavernous hemangiomas are rare, benign vascular malformations which can be challenging to distinguish pre-operatively from malignant lesions such as ACC. CONCLUSION: Cavernous hemangiomas of the adrenal gland are exceedingly rare. These benign tumors have imaging features which may be suggestive of adrenal cortical carcinoma. The treatment of choice is surgical excision due the difficulty of excluding malignancy.
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OBJECTIVE: A meta-analysis of randomized clinical trials (RCTs) was conducted to evaluate whether wound protectors reduce the risk of surgical site infection (SSI) after gastrointestinal and biliary tract surgery. BACKGROUND: The effectiveness of impervious wound edge protectors for reduction of SSI remains unclear. METHODS: A systematic review was conducted in Medline, EMBASE, and the Cochrane Library to identify RCTs that evaluate the risk of SSI after gastrointestinal and biliary surgeries with and without the use of an impervious wound protector. The pooled risk ratio was estimated with random-effect meta-analysis. Sensitivity analyses were performed to examine the impact of structural design of wound protector, publication year, study quality, inclusion of emergent surgeries, preoperative antibiotic administration, and bowel preparation on the pooled risk of SSI. RESULTS: Of the 347 studies identified, 6 RCTs representing 1008 patients were included. The use of a wound protector was associated with a significant decrease in SSI (RR = 0.55, 95% CI 0.31-0.98, P = 0.04). There was a nonsignificant trend toward greater protective effect in studies using a dual ring protector (RR = 0.31, 95% CI 0.14-0.67, P = 0.003), rather than a single ring protector (RR = 0.83, 95% CI 0.38-1.83, P = 0.64). Publication year (P = 0.03) and blinding of outcome assessors (P = 0.04) significantly modified the effect of wound protectors on SSI. CONCLUSIONS: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery.
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Procedimientos Quirúrgicos del Sistema Biliar , Procedimientos Quirúrgicos del Sistema Digestivo , Paños Quirúrgicos , Infección de la Herida Quirúrgica/prevención & control , Diseño de Equipo , Humanos , Equipos de Seguridad , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. METHODS: English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. RESULTS: We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. CONCLUSION: Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.