RESUMO
BACKGROUND: Anaemia is highly prevalent in people with advanced, palliative cancer yet sufficiently effective and safe treatments are lacking. Oral iron is poorly tolerated, and blood transfusion offers only transient benefits. Intravenous iron has shown promise as an effective treatment for anaemia but its use for people with advanced, palliative cancer lacks evidence. AIMS: To assess feasibility of the trial design according to screening, recruitment, and attrition rates. To evaluate the efficacy of intravenous iron to treat anaemia in people with solid tumours, receiving palliative care. DESIGN: A multicentre, randomised, double blind, placebo-controlled trial of intravenous iron (ferric derisomaltose, Monofer®). Outcomes included trial feasibility, change in blood indices, and change in quality of life via three validated questionnaires (EQ5D5L, QLQC30, and the FACIT-F) over 8 weeks. (ISRCTN; 13370767). SETTING/PARTICIPANTS: People with anaemia and advanced solid tumours who were fatigued with a performance status ⩽2 receiving support from a specialist palliative care service. RESULTS: 34 participants were randomised over 16 months (17 iron, 17 placebo). Among those eligible 47% of people agreed to participate and total study attrition was 26%. Blinding was successful in all participants. There were no serious adverse reactions. Results indicated that intravenous iron may be efficacious at improving participant haemoglobin, iron stores and select fatigue specific quality of life measures compared to placebo. CONCLUSION: The trial was feasible according to recruitment and attrition rates. Intravenous iron increased haemoglobin and may improve fatigue specific quality of life measures compared to placebo. A definitive trial is required for confirmation.
Assuntos
Anemia Ferropriva , Anemia , Neoplasias , Humanos , Ferro/uso terapêutico , Ferro/efeitos adversos , Anemia Ferropriva/tratamento farmacológico , Qualidade de Vida , Estudos de Viabilidade , Anemia/tratamento farmacológico , Anemia/etiologia , Hemoglobinas/uso terapêutico , Neoplasias/complicações , Fadiga/tratamento farmacológico , Fadiga/etiologiaRESUMO
OBJECTIVE: To examine the impact of The National Training Program for Lapco on the rate of laparoscopic surgery and clinical outcomes of cases performed by Lapco surgeons after completion of training. SUMMARY OF BACKGROUND DATA: Lapco provided competency-based supervised clinical training for specialist colorectal surgeons in England. METHODS: We compared the rate of laparoscopic surgery, mortality, and morbidity for colorectal cancer resections by Lapco delegates and non-Lapco surgeons in 3-year periods preceding and following Lapco using difference in differences analysis. The changes in the rate of post-Lapco laparoscopic surgery with the Lapco sign-off competency assessment and in-training global assessment scores were examined using risk-adjusted cumulative sum to determine their predictive clinical validity with predefined competent scores of 3 and 5 respectively. RESULTS: One hundred eight Lapco delegates performed 4586 elective colo-rectal resections pre-Lapco and 5115 post-Lapco while non-Lapco surgeons performed 72,930 matched cases. Lapco delegates had a 37.8% increase in laparoscopic surgery which was greater than non-Lapco surgeons by 20.9% [95% confidence interval (CI), 18.5-23.3, P < 0.001) with a relative decrease in 30-day mortality by -1.6% (95% CI, -3.4 to -0.2, P = 0.039) and 90-day mortality by -2.3% (95% CI, -4.3 to -0.4, P = 0.018). The change point of risk-adjusted cumulative sum was 3.12 for competency assessment tool and 4.74 for global assessment score whereas laparoscopic rate increased from 44% to 66% and 40% to 56%, respectively. CONCLUSIONS: Lapco increased the rate of laparoscopic colorectal cancer surgery and reduced mortality and morbidity in England. In-training competency assessment tools predicted clinical performance after training.
Assuntos
Neoplasias Colorretais , Cirurgia Colorretal , Laparoscopia , Competência Clínica , Neoplasias Colorretais/cirurgia , Cirurgia Colorretal/educação , Inglaterra , Humanos , Laparoscopia/educaçãoRESUMO
INTRODUCTION: There has been a constant increase in the number of published surgical videos with preference for open-access sources, but the proportion of videos undergoing peer-review prior to publication has markedly decreased, raising questions over quality of the educational content presented. The aim of this study was the development and validation of a standard framework for the appraisal of surgical videos submitted for presentation and publication, the LAParoscopic surgery Video Educational GuidelineS (LAP-VEGaS) video assessment tool. METHODS: An international committee identified items for inclusion in the LAP-VEGaS video assessment tool and finalised the marking score utilising Delphi methodology. The tool was finally validated by anonymous evaluation of selected videos by a group of validators not involved in the tool development. RESULTS: 9 items were included in the LAP-VEGaS video assessment tool, with every item scoring from 0 (item not presented in the video) to 2 (item extensively presented in the video), with a total marking score ranging from 0 to 18. The LAP-VEGaS video assessment tool resulted highly accurate in identifying and selecting videos for acceptance for conference presentation and publication, with high level of internal consistency and generalisability. CONCLUSIONS: We propose that peer review in adherence to the LAP-VEGaS video assessment tool could enhance the overall quality of published video outputs.
Assuntos
Lista de Checagem , Avaliação Educacional , Guias como Assunto , Laparoscopia/normas , Gravação em Vídeo/normas , Humanos , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: To compare the impact of the use of oral antibiotics (OAB) with or without mechanical bowel preparation (MBP) on outcome in elective colorectal surgery. SUMMARY BACKGROUND DATA: Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or mortality, and as such it should not be prescribed routinely. However, recent evidence from large retrospective cohort and database studies has suggested that there may be a role for combined OAB and MBP, or OAB alone in the prevention of surgical site infection (SSI). METHODS: A meta-analysis of randomized controlled trials and cohort studies including adult patients undergoing elective colorectal surgery, receiving OAB with or without MBP was performed. The outcome measures examined were SSI, anastomotic leak, 30-day mortality, overall morbidity, development of ileus, reoperation and Clostridium difficile infection. RESULTS: A total of 40 studies with 69,517 patients (28 randomized controlled trials, n = 6437 and 12 cohort studies, n = 63,080) were included. The combination of MBP+OAB versus MBP alone was associated with a significant reduction in SSI [risk ratio (RR) 0.51, 95% confidence interval (CI) 0.46-0.56, P < 0.00001, I = 13%], anastomotic leak (RR 0.62, 95% CI 0.55-0.70, P < 0.00001, I = 0%), 30-day mortality (RR 0.58, 95% CI 0.44-0.76, P < 0.0001, I = 0%), overall morbidity (RR 0.67, 95% CI 0.63-0.71, P < 0.00001, I = 0%), and development of ileus (RR 0.72, 95% CI 0.52-0.98, P = 0.04, I = 36%), with no difference in Clostridium difficile infection rates. When a combination of MBP+OAB was compared with OAB alone, no significant difference was seen in SSI or anastomotic leak rates, but there was a significant reduction in 30-day mortality, and incidence of postoperative ileus with the combination. There is minimal literature available on the comparison between combined MBP+OAB versus no preparation, OAB alone versus no preparation, and OAB versus MBP. CONCLUSIONS: Current evidence suggests a potentially significant role for OAB preparation, either in combination with MBP or alone, in the prevention of postoperative complications in elective colorectal surgery. Further high-quality evidence is required to differentiate between the benefits of combined MBP+OAB or OAB alone.
Assuntos
Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Catárticos/uso terapêutico , Colectomia , Procedimentos Cirúrgicos Eletivos , Protectomia , Infecção da Ferida Cirúrgica/prevenção & controle , Administração Oral , Fístula Anastomótica/prevenção & controle , Clostridioides difficile , Infecções por Clostridium/etiologia , Infecções por Clostridium/prevenção & controle , Terapia Combinada , Humanos , Íleus/etiologia , Íleus/prevenção & controle , Resultado do TratamentoRESUMO
BACKGROUND: Preoperative anaemia is common and occurs in 5% to 76% of patients preoperatively. It is associated with an increased risk of perioperative allogeneic blood transfusion, longer hospital stay, and increased morbidity and mortality. Iron deficiency is one of the most common causes of anaemia. Oral and intravenous iron therapy can be used to treat anaemia. Parenteral iron preparations have been shown to be more effective in conditions such as inflammatory bowel disease, chronic heart failure and postpartum haemorrhage due to rapid correction of iron stores. A limited number of studies has investigated iron therapy for the treatment of preoperative anaemia. The aim of this Cochrane Review is to summarise the evidence for iron supplementation, both enteral and parenteral, for the management of preoperative anaemia. OBJECTIVES: To evaluate the effects of preoperative iron therapy (enteral or parenteral) in reducing the need for allogeneic blood transfusions in anaemic patients undergoing surgery. SEARCH METHODS: We ran the search on 30 July 2018. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic and Embase (Ovid), CINAHL Plus (EBSCO), PubMed, and clinical trials registries, and we screened reference lists. We ran a top-up search on 28 November 2019; one study is now awaiting classification. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) that compared preoperative iron monotherapy to placebo, no treatment, standard care or another form of iron therapy for anaemic adults undergoing surgery. We defined anaemia as haemoglobin values less than 13 g/dL for males and 12 g/dL for non-pregnant females. DATA COLLECTION AND ANALYSIS: Two review authors collected data and a third review author checked all collected data. Data were collected on the proportion of patients who receive a blood transfusion, the amount of blood transfused per patient (units), quality of life, ferritin levels and haemoglobin levels, measured as continuous variables at the following predetermined time points: pretreatment (baseline), preoperatively but postintervention, and postoperatively. We performed statistical analysis using the Cochrane software, Review Manager 5. We summarised outcome data in tables and forest plots. We used the GRADE approach to describe the quality of the body of evidence. MAIN RESULTS: Six RCTs, with a total of 372 participants, evaluated preoperative iron therapy to correct anaemia before planned surgery. Four studies compared iron therapy (either oral (one study) or intravenous (three studies)) with no treatment, placebo or usual care, and two studies compared intravenous iron therapy with oral iron therapy. Iron therapy was delivered over a range of periods that varied from 48 hours to three weeks prior to surgery. The 372 participants in our analysis fall far short of the 819 required - as calculated by our information size calculation - to detect a 30% reduction in blood transfusions. Five trials, involving 310 people, reported the proportion of participants who received allogeneic blood transfusions. Meta-analysis of iron therapy versus placebo or standard care showed no difference in the proportion of participants who received a blood transfusion (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.87 to 1.70; 4 studies, 200 participants; moderate-quality evidence). Only one study that compared oral versus intravenous iron therapy measured this outcome, and reported no difference in risk of transfusion between groups. There was no difference between the iron therapy and placebo/standard care groups for haemoglobin level preoperatively at the end of the intervention (mean difference (MD) 0.63 g/dL, 95% CI -0.07 to 1.34; 2 studies, 83 participants; low-quality evidence). However, intravenous iron therapy produced an increase in preoperative postintervention haemoglobin levels compared with oral iron (MD 1.23 g/dL, 95% CI 0.80 to 1.65; 2 studies, 172 participants; low-quality evidence). Ferritin levels were increased by intravenous iron, both when compared to standard care ((MD 149.00, 95% CI 25.84 to 272.16; 1 study, 63 participants; low-quality evidence) or to oral iron (MD 395.03 ng/mL, 95% CI 227.72 to 562.35; 2 studies, 151 participants; low-quality evidence). Not all studies measured quality of life, short-term mortality or postoperative morbidity. Some measured the outcomes, but did not report the data, and the studies which did report the data were underpowered. Therefore, uncertainty remains regarding these outcomes. The inclusion of new research in the future is very likely to change these results. AUTHORS' CONCLUSIONS: The use of iron therapy for preoperative anaemia does not show a clinically significant reduction in the proportion of trial participants who received an allogeneic blood transfusion compared to no iron therapy. Results for intravenous iron are consistent with a greater increase in haemoglobin and ferritin when compared to oral iron, but do not provide reliable evidence. These conclusions are drawn from six studies, three of which included very small numbers of participants. Further, well-designed, adequately powered, RCTs are required to determine the true effectiveness of iron therapy for preoperative anaemia. Two studies are currently in progress, and will include 1500 randomised participants.
Assuntos
Anemia Ferropriva/terapia , Ferro da Dieta/administração & dosagem , Cuidados Pré-Operatórios , Anemia Ferropriva/prevenção & controle , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Surgical trainers consider laparoscopic videos as a useful teaching aid to maximize trainees' learning and skill development given the backdrop of time constraints and productivity demands. Aim of this study is to assess the current use of laparoscopic videos amongst surgical trainees in the United Kingdom. METHODS: A steering committee of 15 experienced laparoscopic trainers from 8 countries developed a survey on the use of laparoscopic videos by surgical trainees. The survey items were finalized by discussion through e-mails, teleconferences, and face-to-face meetings and a finalised questionnaire was distributed amongst surgical trainees in the United Kingdom. RESULTS: 92 trainees were invited and 75 returned the questionnaire (81.5%). 86.7% of the trainees routinely watched online surgical videos and the more frequently used websites were Youtube.com and Websurg.com. Trainees require laparoscopic videos to have supplementary educational content such as English commentary (90.7%) and use of snapshots (93.3%) and diagrams (86.7%). Position of the patient and trocars, indication for surgery, preoperative data and postoperative outcomes are required characteristics of laparoscopic videos. 29 trainees (38.7%) do not record the laparoscopic procedures they perform, despite the majority of them recognising the usefulness of routine video-recording for training purposes (78.7%). CONCLUSIONS: Surgical trainees consider videos a useful adjunct in laparoscopic surgery training, with preference for open access sources. Trainees value highly informative videos with supplementary educational content.
Assuntos
Instrução por Computador , Educação a Distância , Laparoscopia/educação , Gravação em Vídeo , Competência Clínica , Currículo , Feminino , Humanos , Masculino , Reino UnidoRESUMO
OBJECTIVE: Consensus statement by an international multispecialty trainers and trainees expert committee on guidelines for reporting of educational videos in laparoscopic surgery. SUMMARY OF BACKGROUND DATA: Instructive laparoscopy videos with appropriate exposition could be ideal for initial training in laparoscopic surgery, but there are no guidelines for video annotation or procedural educational and safety evaluation. METHODS: Delphi questionnaire of 45 statements prepared by a steering group and voted on over 2 rounds by committee members using an electronic survey tool. Committee selection design included representative surgical training experts worldwide across different laparoscopic specialties, including general surgery, lower and upper gastrointestinal surgery, gynecology and urology, and a proportion of aligned surgical trainees. RESULTS: All 33 committee members completed both the first and the second round of the Delphi questionnaire related to 7 major domains: Video Introduction/Authors' information; Patient Details; Procedure Description; Procedure Outcome; Associated Educational Content; Peer Review; and Use in Educational Curriculae. The 17 statements that did not reach at least 80% agreement after the first round were revised and returned into the second round. The committee consensus approved 37 statements to at least an 82% agreement. CONCLUSION: Consensus guidelines on how to report laparoscopic surgery videos for educational purposes have been developed. We anticipate that following our guidelines could help to improve video quality.These reporting guidelines may be useful as a standard for reviewing videos submitted for publication or conference presentation.
Assuntos
Educação a Distância/normas , Laparoscopia/educação , Gravação em Vídeo/normas , Competência Clínica , Consenso , Currículo , Técnica Delphi , Humanos , InternetRESUMO
BACKGROUND: Anemia is common with esophagogastric adenocarcinoma, increasing mortality, blood transfusions, and reducing quality of life (QOL). No clear evidence exists for safe and effective treatment. METHODS: Anemic patients (Hb <12 g/dl women, <13 g/dl men) with esophagogastric adenocarcinoma were recruited before initiation of palliative chemotherapy. Patients were randomized to standard care or single dose of intravenous iron isomaltoside (IVI) before chemotherapy. Post-chemotherapy changes in hemoglobin (Hb), ferritin, transferrin saturations (TSAT), blood transfusions, and QOL were recorded for three cycles of chemotherapy. RESULTS: Twenty-seven patients were randomized to standard care (n = 13) or IVI (n = 14). No significant change in Hb was seen (standard care MD -0.6 g/dl 95% CI -0.1-1.1 g/dl, P = 0.336; IVI MD +0.5 g/dl 95% CI -0.1-1.1 g/dl, P = 0.903). An increase in ferritin was seen with IVI after cycle one of chemotherapy (standard care 116 ng/ml; IVI 770 ng/ml, P < 0.05). No difference in blood transfusions was seen between groups (P = 0.851). IVI improved QOL with physical well-being, emotional well-being, anemia-specific QOL, trial outcome index, and total scores all exceeding minimum clinically important difference. No improvement was seen with standard care. CONCLUSIONS: This feasibility study suggests IVI improves quality of life and ferritin. Larger adequately powered studies are required to definitively conclude if hemoglobin and blood transfusion changes with IVI.
Assuntos
Adenocarcinoma/tratamento farmacológico , Anemia/tratamento farmacológico , Dissacarídeos/administração & dosagem , Neoplasias Esofágicas/tratamento farmacológico , Compostos Férricos/administração & dosagem , Neoplasias Gástricas/tratamento farmacológico , Adenocarcinoma/complicações , Administração Intravenosa/efeitos adversos , Adulto , Idoso , Anemia/sangue , Transfusão de Sangue , Dissacarídeos/efeitos adversos , Neoplasias Esofágicas/complicações , Estudos de Viabilidade , Feminino , Compostos Férricos/efeitos adversos , Hemoglobinas/análise , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Paliativos , Qualidade de Vida , Neoplasias Gástricas/complicações , Transferrina/análiseRESUMO
BACKGROUND: Pre-operative anaemia is common and occurs in up to 76% of patients. It is associated with increased peri-operative allogeneic blood transfusions, longer hospital lengths of stay and increased morbidity and mortality. Iron deficiency is one of the most common causes of this anaemia. Oral iron therapy has traditionally been used to treat anaemia but newer, safer parenteral iron preparations have been shown to be more effective in other conditions such as inflammatory bowel disease, chronic heart failure and post-partum haemorrhage. A limited number of studies look at iron therapy for the treatment of pre-operative anaemia. The aim of this Cochrane review is to summarise the evidence for use of iron supplementation, both enteral and parenteral, for the management of pre-operative anaemia. OBJECTIVES: The objective of this review is to evaluate the effects of pre-operative iron therapy (enteral or parenteral) in reducing the need for allogeneic blood transfusions in anaemic patients undergoing surgery. SEARCH METHODS: We ran the search on 25 March 2015. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), EMBASE Classic and EMBASE (Ovid), CINAHL Plus (EBSCO), PubMed, clinical trials registries, conference abstracts, and we screened reference lists. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) which compared pre-operative iron monotherapy to placebo, no treatment, standard of care or another form of iron therapy for anaemic adults undergoing surgery. Anaemia was defined by haemoglobin values less than 13 g/dL for males and 12 g/dL for non-pregnant females. DATA COLLECTION AND ANALYSIS: Data were collected by two authors on the proportion of patients who receive a blood transfusion, amount of blood transfused per patient (units) and haemoglobin measured as continuous variables at pre-determined time-points: pre-treatment, pre-operatively but post-treatment, and post-operatively. Statistical analysis was performed using the Cochrane statistical software, Review Manager 2014. Outcome data were summarised in tables and a forest plot. MAIN RESULTS: Three prospective randomised controlled studies evaluated pre-operative iron therapy to correct anaemia (two in colorectal and one in gynaecological surgery) and included 114 patients in total. One compared oral iron versus standard care (Lidder 2007); one intravenous iron versus control (Edwards 2009); and one study compared oral versus intravenous iron (Kim 2009). Both colorectal trials reported the primary outcome (proportion of patients who received allogeneic blood transfusions) and meta-analysis showed a reduction in blood transfusions with the administration of iron therapy, but the reduction was not statistically significant (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.27 to 1.18). All studies reported haemoglobin change but data for the anaemic patients were only available for two studies (Edwards 2009 and Kim 2009). Edwards 2009 showed no difference in haemoglobin at the end of treatment pre-operatively. The intravenous versus oral iron study showed an increase in haemoglobin with intravenous iron at the end of treatment pre-operatively (MD 1.90 g/dL, 95% CI 1.16 to 2.64; participants = 56), but the results are at high risk of bias because participants with less than 80% compliance with therapy were excluded from the analysis and compliance was lower in the oral iron group due to the side-effects of treatment (Kim 2009).None of the studies reported quality of life, short- or long-term mortality or post-operative morbidity. AUTHORS' CONCLUSIONS: The use of iron therapy for pre-operative anaemia does not show a statistically significant reduction in the proportion of patients who received an allogeneic blood transfusion compared to no iron therapy. However, the 38 patients in our analysis falls far short of the 819 patients our information size calculation recommended to detect a 30% reduction in blood transfusions. Intravenous iron may be more effective than oral iron at increasing haemoglobin. However, all these conclusions are drawn from only three small randomised controlled studies. Further well designed, adequately powered randomised controlled studies are required to determine the true effectiveness of iron therapy for pre-operative anaemia.
Assuntos
Anemia/terapia , Transfusão de Sangue/estatística & dados numéricos , Ferro/administração & dosagem , Cuidados Pré-Operatórios , Administração Oral , Adulto , Anemia/sangue , Ferritinas/sangue , Hematócrito , Hemoglobina A/análise , Humanos , Injeções Intravenosas , Ensaios Clínicos Controlados Aleatórios como Assunto , Contagem de Reticulócitos , Procedimentos Cirúrgicos OperatóriosRESUMO
BACKGROUND: Optimal analgesia following laparoscopic colorectal resection is yet to be determined; however, recent studies have questioned the role of postoperative epidural anaesthesia, suggesting other analgesic modalities may be preferable. The aim of this randomised controlled trial was to assess the effect of transversus abdominis plane (TAP) blocks on opioid requirements in patients undergoing laparoscopic colorectal resection. METHODS: After appropriate trial registration ( www.clinicaltrials.gov NCT 00830089) and local medical ethics review board approval (REC 09/H0407/10), all adult patients who were to undergo laparoscopic colorectal surgery at a single centre were randomised into the intervention group receiving bilateral TAP blocks or the control group (no TAP block). The blocks were administered prior to surgery after the induction of a standardised anaesthetic by an anaesthetist otherwise uninvolved with the case. The patient, theatre anaesthetist, surgeon, and ward staff were blinded to treatment allocation. All patients received postoperative analgesia of paracetamol and morphine as a patient-controlled analgesia (PCA). Cumulative opioid consumption and pain scores were recorded at 2, 4, 6, and 24 h postoperatively and compared between the groups as were clinical outcomes and length of stay. RESULTS: The intervention (TAP block) group (n = 33) and the control group (n = 35) were comparable with respect to characteristics, specimen pathology, and type of procedure. The TAP block group's median cumulative morphine usage (40 mg [IQR = 25-63]) was significantly less than that of the control group (60 mg [IQR = 39-81]). Pain scores and median length of stay (LOS) were similar between the two groups. CONCLUSION: Preoperative TAP blocks in patients undergoing laparoscopic colorectal resection reduced opioid use in the first postoperative day in this study.
Assuntos
Colo/cirurgia , Laparoscopia , Bloqueio Nervoso/métodos , Dor Pós-Operatória/prevenção & controle , Reto/cirurgia , Músculos Abdominais/inervação , Parede Abdominal/inervação , Idoso , Analgésicos Opioides/uso terapêutico , Neoplasias Colorretais/cirurgia , Método Duplo-Cego , Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Tempo de Internação , Vértebras Lombares/inervação , Masculino , Morfina/uso terapêutico , Vértebras Torácicas/inervação , Ultrassonografia de Intervenção , Escala Visual AnalógicaRESUMO
BACKGROUND: The self-taught learning curve in laparoscopic colorectal surgery (LCS) is between 100 and 150 cases. Supervised training has been shown to shorten the proficiency gain curve of senior specialist surgeons. Little is known about the learning curve of LCS trainees undergoing mentored training. The aim of this study was to analyze the proficiency gain curve and clinical outcomes of English surgical trainees during laparoscopic colorectal surgery fellowships. METHODS: In 2010 the educational, Web-based platform from the National Training Program in Laparoscopic Colorectal Surgery in England was newly available to surgical trainees undertaking a laparoscopic colorectal fellowship. These fellows were asked to submit clinical outcomes, including patient demographics and case specifications. In addition, self-perceived performance was evaluated using a validated task-specific self-assessment form [global assessment scale (GAS) range 1-6]. Proficiency gain curves and learning rates were evaluated using risk-adjusted (RA) cumulative sum (CUSUM) curves. RESULTS: Of 654 cases 608 were included for analysis. The clinical outcomes included 9.2 % conversions, 16.9 % complications, 4 % reoperations, 2.6 % readmissions and a 0.8 % in-hospital mortality rate. RA CUSUM curves for complications and reoperation do not show a learning effect. However, the RA CUSUM curve for conversion has an inflection point at 24 cases. The GAS CUSUM curves for 'setup' and 'exposure' have inflection points at case 15 and case 29 respectively. The curves for 'mobilization of colon,' 'vascular pedicle' and 'anastomosis' plateau towards the end of the training period. 'Flexure' and 'mesorectum' do not of reach a plateau by case 40. CONCLUSIONS: Supervised fellowships provide training in LCS without compromising patient safety. Forty cases are required for the fellows to feel confident to perform the majority of tasks except dissection of the mesorectum and flexure, which will require further training.
Assuntos
Competência Clínica , Internato e Residência , Laparoscopia/educação , Mentores , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Inglaterra , Feminino , Humanos , Curva de Aprendizado , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND AND AIMS: Inflammatory bowel disease colitis-associated dysplasia is managed with either enhanced surveillance and endoscopic resection or prophylactic surgery. The rate of progression to cancer after a dysplasia diagnosis remains uncertain in many cases and patients have high thresholds for accepting proctocolectomy. Individualised discussion of management options is encouraged to take place between patients and their multidisciplinary teams for best outcomes. We aimed to develop a toolkit to support a structured, multidisciplinary and shared decision-making approach to discussions about dysplasia management options between clinicians and their patients. METHODS: Evidence from systematic literature reviews, mixed-methods studies conducted with key stakeholders, and decision-making expert recommendations were consolidated to draft consensus statements by the DECIDE steering group. These were then subjected to an international, multidisciplinary modified electronic Delphi process until an a priori threshold of 80% agreement was achieved to establish consensus for each statement. RESULTS: In all, 31 members [15 gastroenterologists, 14 colorectal surgeons and two nurse specialists] from nine countries formed the Delphi panel. We present the 18 consensus statements generated after two iterative rounds of anonymous voting. CONCLUSIONS: By consolidating evidence for best practice using literature review and key stakeholder and decision-making expert consultation, we have developed international consensus recommendations to support health care professionals counselling patients on the management of high cancer risk colitis-associated dysplasia. The final toolkit includes clinician and patient decision aids to facilitate shared decision-making.
Assuntos
Colite , Doenças Inflamatórias Intestinais , Neoplasias , Humanos , Técnica Delphi , Hiperplasia , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/terapia , Risco , Revisões Sistemáticas como AssuntoRESUMO
OBJECTIVE: To determine the effect of allogeneic blood transfusion (ABT) on clinical outcomes in patients with colorectal cancer undergoing surgery. BACKGROUND: Perioperative ABTs may be associated with adverse clinical outcomes. METHODS: Systematic review of the literature with odds ratio (OR) and incidence rate ratio (IRR) meta-analyses of predefined clinical outcomes based on a MEDLINE search. RESULTS: In total, 20,795 colorectal cancer (CRC) patients observed for more than 59.2 ± 26.1 months (108,838 patient years) were included, of which 58.8% were transfused. ABT was associated with increased all-cause mortality OR = 1.72 (95% confidence interval [CI] 1.55-1.91, P < 0.001); I(2) = 23.3% (0-51.1) and IRR = 1.31 (1.23-1.39, P < 0.001), I(2) = 0.0% (0-37.0). ABT was also associated with increased ORs (95% CI, P) for cancer-related mortality of 1.71 (1.43-2.05, P <0.001), combined recurrence-metastasis-death 1.66 (1.41-1.97, P < 0.001), postoperative infection 3.27 (2.05-5.20, P < 0.001), and surgical reintervention 4.08 (2.18-7.62, <0.001). IRR (95% CI, P) was 1.45 (1.26-1.66, <0.001) for cancer-related mortality and 1.32 (1.19-1.46, <0.001) for recurrence-metastasis-death. Mean length of hospital stay was significantly longer in transfused compared with nontransfused patients (17.8 ± 4.8 vs 13.9 ± 4.7 days, P = 0.005). CONCLUSIONS: In patients with colorectal cancer (CRC) undergoing surgery, ABTs are associated with adverse clinical outcomes, including increased mortality. Measures aimed at limiting the use of ABTs should be investigated further.
Assuntos
Neoplasias Colorretais/cirurgia , Transfusão de Eritrócitos , Neoplasias Colorretais/mortalidade , Humanos , Tempo de Internação , Razão de Chances , Prognóstico , Resultado do TratamentoAssuntos
Auditoria Clínica/estatística & dados numéricos , Cirurgia Colorretal/estatística & dados numéricos , Bases de Dados Factuais , Hospitais/estatística & dados numéricos , Doenças Inflamatórias Intestinais/cirurgia , Bolsas Cólicas/normas , Bolsas Cólicas/estatística & dados numéricos , Cirurgia Colorretal/normas , Inglaterra , Hospitais/normas , HumanosRESUMO
BACKGROUND: This study aimed to determine and compare the opinions of trainees and trainers attending courses using two simulation models (fresh frozen cadavers or anaesthetized pigs) and to assess trainees' degree of insight into both the difficulty of different procedures and their operative performance in the simulated environment. METHODS: Trainers and trainees attending the training courses completed questionnaires. Performance was evaluated using the Global Assessment Score (GAS). RESULTS: Data were collected over a 12-month period from 26 trainers and 77 trainees. The overall satisfaction was high after attendance at either course (4.50 vs. 4.49; p=0.83). When the opinions of the trainees and trainers in cadaveric and animal courses were compared, the findings rated the animal model as superior in terms of tissue quality (3.97 vs. 3.55; p=0.02), persistence of air leak (1.43 vs. 2.40; p<0.001), and lack of disturbance by odor (4.24 vs. 3.41; p<0.001). The cadaveric model provided more realistic simulation for port placement (4.02 vs. 3.11; p<0.001) and anatomy (4.25 vs. 3.00; p<0.001) and was perceived to be superior as a training model (4.53 vs. 3.61; p=0.001). The trainees demonstrated good insight into procedure difficulty and their operative performance. The trainees and trainers were shown to have a good concordance of scores. The trainees were more inclined to underrate and the peers to overrate their performance. CONCLUSIONS: Trainees appear to have a good insight into procedure difficulty and their ability. Both training models have advantages and disadvantages, but overall, the cadaveric model is perceived to have a higher fidelity and greater educational value.
Assuntos
Cirurgia Colorretal/educação , Educação Médica Continuada , Laparoscopia/educação , Adulto , Animais , Atitude do Pessoal de Saúde , Cadáver , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Sus scrofaRESUMO
Importance: Intravenous iron is recommended by many clinical guidelines based largely on its effectiveness in reducing anemia. However, the association with important safety outcomes, such as infection, remains uncertain. Objective: To examine the risk of infection associated with intravenous iron compared with oral iron or no iron. Data Sources: Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials (RCTs) from 1966 to January 31, 2021. Ongoing trials were sought from ClinicalTrials.gov, CENTRAL, and the World Health Organization International Clinical Trials Search Registry Platform. Study Selection: Pairs of reviewers identified RCTs that compared intravenous iron with oral iron or no iron across all patient populations, excluding healthy volunteers. Nonrandomized studies published since January 1, 2007, were also included. A total of 312 full-text articles were assessed for eligibility. Data Extraction and Synthesis: Data extraction and risk of bias assessments were performed according to the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) and Cochrane recommendations, and the quality of evidence was assessed using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Two reviewers extracted data independently. A random-effects model was used to synthesize data from RCTs. A narrative synthesis was performed to characterize the reporting of infection. Main Outcomes and Measures: The primary outcome was risk of infection. Secondary outcomes included mortality, hospital length of stay, and changes in hemoglobin and red blood cell transfusion requirements. Measures of association were reported as risk ratios (RRs) or mean differences. Results: A total of 154 RCTs (32â¯920 participants) were included in the main analysis. Intravenous iron was associated with an increased risk of infection when compared with oral iron or no iron (RR, 1.17; 95% CI, 1.04-1.31; I2 = 37%; moderate certainty of evidence). Intravenous iron also was associated with an increase in hemoglobin (mean difference, 0.57 g/dL; 95% CI, 0.50-0.64 g/dL; I2 = 94%) and a reduction in the risk of requiring a red blood cell transfusion (RR, 0.93; 95% CI, 0.76-0.89; I2 = 15%) when compared with oral iron or no iron. There was no evidence of an effect on mortality or hospital length of stay. Conclusions and Relevance: In this large systematic review and meta-analysis, intravenous iron was associated with an increased risk of infection. Well-designed studies, using standardized definitions of infection, are required to understand the balance between this risk and the potential benefits.
Assuntos
Anemia Ferropriva/tratamento farmacológico , Infecções/epidemiologia , Ferro/efeitos adversos , Administração Intravenosa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia Ferropriva/microbiologia , Transfusão de Sangue/estatística & dados numéricos , Feminino , Hemoglobinas/análise , Humanos , Infecções/induzido quimicamente , Ferro/administração & dosagem , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados não Aleatórios como Assunto , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Adulto JovemRESUMO
Iron deficiency anemia is a common complication of colorectal cancer and may require iron therapy. Oral iron can increase the iron available to gut bacteria and may alter the colonic microbiota. We performed an intervention study to compare oral and intravenous iron therapy on the colonic tumor-associated (on-tumor) and paired non-tumor-associated adjacent (off-tumor) microbiota. Anemic patients with colorectal adenocarcinoma received either oral ferrous sulphate (n = 16) or intravenous ferric carboxymaltose (n = 24). On- and off-tumor biopsies were obtained post-surgery and microbial profiling was performed using 16S ribosomal RNA analysis. Off-tumor α- and ß-diversity were significantly different between iron treatment groups. No differences in on-tumor diversity were observed. Off-tumor microbiota of oral iron-treated patients showed higher abundances of the orders Clostridiales, Cytophagales, and Anaeroplasmatales compared to intravenous iron-treated patients. The on-tumor microbiota was enriched with the orders Lactobacillales and Alteromonadales in the oral and intravenous iron groups, respectively. The on- and off-tumor microbiota associated with intravenous iron-treated patients infers increased abundances of enzymes involved in iron sequestration and anti-inflammatory/oncogenic metabolite production, compared to oral iron-treated patients. Collectively, this suggests that intravenous iron may be a more appropriate therapy to limit adverse microbial outcomes compared to oral iron.
RESUMO
Oral iron promotes intestinal tumourigenesis in animal models. In humans, expression of iron transport proteins are altered in colorectal cancer. This study examined whether the route of iron therapy alters iron transport and tumour growth. Colorectal adenocarcinoma patients with pre-operative iron deficiency anaemia received oral ferrous sulphate (n = 15), or intravenous ferric carboxymaltose (n = 15). Paired (normal and tumour tissues) samples were compared for expression of iron loading, iron transporters, proliferation, apoptosis and Wnt signalling using immunohistochemistry and RT-PCR. Iron loading was increased in tumour and distributed to the stroma in intravenous treatment and to the epithelium in oral treatment. Protein and mRNA expression of proliferation and iron transporters were increased in tumours compared to normal tissues but there were no significant differences between the treatment groups. However, intravenous iron treatment reduced ferritin mRNA levels in tumours and replenished body iron stores. Iron distribution to non-epithelial cells in intravenous iron suggests that iron is less bioavailable to tumour cells. Therefore, intravenous iron may be a better option in the treatment of colorectal cancer patients with iron deficiency anaemia due to its efficiency in replenishing iron levels while its effect on proliferation and iron metabolism is similar to that of oral iron treatment.