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Importance: When considering nonoperative treatment in a patient with acute appendicitis, it is crucial to accurately rule out complicated appendicitis. The Atema score, also referred to as the Scoring System of Appendicitis Severity (SAS), has been designed to differentiate between uncomplicated and complicated appendicitis but has not been prospectively externally validated. Objective: To externally validate the SAS and, in case of failure, to develop an improved SAS (2.0) for estimating the probability of complicated appendicitis. Design, Setting, and Participants: This prospective study included adult patients who underwent operations for suspected acute appendicitis at 11 hospitals in the Netherlands between January 2020 and August 2021. Main Outcomes and Measures: Appendicitis severity was predicted according to the SAS in 795 patients and its sensitivity and negative predictive value (NPV) for complicated appendicitis were calculated. Since the predefined targets of 95% for both were not met, the SAS 2.0 was developed using the same cohort. This clinical prediction model was developed with multivariable regression using clinical, biochemical, and imaging findings. The SAS 2.0 was externally validated in a temporal validation cohort consisting of 565 patients. Results: In total, 1360 patients were included, 463 of whom (34.5%) had complicated appendicitis. Validation of the SAS resulted in a sensitivity of 83.6% (95% CI, 78.8-87.6) and an NPV of 85.0% (95% CI, 80.6-88.8), meaning that the predefined targets were not achieved. Therefore, the SAS 2.0 was developed, internally validated (C statistic, 0.87; 95% CI, 0.84-0.89), and subsequently externally validated (C statistic, 0.86; 95% CI, 0.82-0.89). The SAS 2.0 was designed to calculate a patient's individual probability of having complicated appendicitis along with a 95% CI. Conclusions and Relevance: In this study, external validation of the SAS fell short in accurately distinguishing complicated from uncomplicated appendicitis. The newly developed and externally validated SAS 2.0 was able to assess an individual patient's probability of having complicated appendicitis with high accuracy in patients with acute appendicitis. Use of this patient-specific risk assessment tool can be helpful when considering and discussing nonoperative treatment of acute appendicitis with patients.
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Apendicite , Índice de Gravidade de Doença , Humanos , Apendicite/diagnóstico , Apendicite/complicações , Feminino , Masculino , Adulto , Estudos Prospectivos , Pessoa de Meia-Idade , Países Baixos , Apendicectomia , Valor Preditivo dos TestesRESUMO
PURPOSE: To determine the accuracy of final judgements of doctors at the emergency department (ED) and radiologists to differentiate between complicated and uncomplicated acute appendicitis, because these have different treatment options. METHODS: This prospective, multicenter study included adult patients with imaging-confirmed acute appendicitis, operated with intention to appendectomy. Both doctors at ED and radiologists assessed appendicitis severity as a final judgement of "uncomplicated" or "complicated" appendicitis. Doctors at ED integrated clinical, laboratory, and imaging findings. Radiologists relied solely on imaging findings. Outcomes were accuracy of these judgements for diagnosis of complicated appendicitis compared to the reference standard by an adjudication committee. RESULTS: After imaging, 1070 patients with confirmed acute appendicitis were included. Doctors at ED accurately labelled 656 of 701 (93.6%) patients with true uncomplicated appendicitis as uncomplicated, and 163 of 369 (44.2%) patients with true complicated appendicitis were labelled as complicated. Sensitivity, specificity, and positive and negative predictive values (PPV and NPV) for complicated appendicitis were 44.2%, 93.6%, and 78.4% and 76.1%, respectively. Comparable accuracy was found for the radiologist's assessment in 941 patients, with true positive rates of 92.2% (581 of 630 patients) for uncomplicated appendicitis and 46.6% (145 of 311 patients) for complicated appendicitis. CONCLUSION: More than half of all patients with true complicated appendicitis is incorrectly classified as uncomplicated appendicitis according to the judgements of doctors at ED, integrating clinical, laboratory, and imaging results, and of radiologists assessing diagnostic imaging. These judgements are thereby not sufficiently reliable in ruling out complicated appendicitis.
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Apendicite , Serviço Hospitalar de Emergência , Radiologistas , Humanos , Apendicite/diagnóstico por imagem , Apendicite/diagnóstico , Apendicite/cirurgia , Estudos Prospectivos , Masculino , Adulto , Feminino , Diagnóstico Diferencial , Pessoa de Meia-Idade , Apendicectomia , Sensibilidade e Especificidade , Competência Clínica , Doença Aguda , Valor Preditivo dos Testes , Tomografia Computadorizada por Raios XRESUMO
OBJECTIVE: To compare costs for 2 days versus 5 days of postoperative antibiotics within the antibiotics after an aPPendectomy In Complex appendicitis trial.Background:Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stays without compromising patient safety. Its potential effect on societal costs remains underexplored. METHODS: This was a pragmatic, open-label, multicenter clinical trial powered for noninferiority. Patients with complex appendicitis (age ≥ 8 years) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. The final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, the main outcome measures were overall societal costs (comprising direct health care costs and costs related to productivity loss) and cost-effectiveness. Direct health care costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity Cost Questionnaire at 4 weeks after surgery. Cost estimates were based on prices for the year 2019. RESULTS: In total, 1005 patients were evaluated in the "intention-to-treat" analysis: 502 patients were allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was - 625 (95% CI: - 958 to - 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to 2 days was cost-effective, with estimated cost savings of 31,117 per additional infectious complication. CONCLUSIONS: Two days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced health care setting.
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Antibacterianos , Apendicite , Humanos , Criança , Antibacterianos/uso terapêutico , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Apendicectomia/métodos , Tempo de Internação , Custos de Cuidados de Saúde , Resultado do TratamentoRESUMO
BACKGROUND: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. METHODS: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. FINDINGS: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202). INTERPRETATION: Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation. FUNDING: Vifor Pharma.
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Anemia Ferropriva , Neoplasias Colorretais , Adulto , Masculino , Humanos , Feminino , Ferro , Anemia Ferropriva/etiologia , Anemia Ferropriva/complicações , Hemoglobinas , Suplementos Nutricionais , Neoplasias Colorretais/complicações , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/cirurgiaRESUMO
BACKGROUND: The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. METHODS: In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946. FINDINGS: Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI -1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) than in the 5-day group (112 [22%] of 503 patients; odds ratio [OR] 0·344, 95% CI 0·237 to 0·498). Re-admission to hospital was more frequent in the 2-day group (58 [12%] of 502 patients) than in the 5-day group (29 [6%] of 503 patients; OR 2·135, 1·342 to 3·396). There were no treatment-related deaths. INTERPRETATION: 2 days of postoperative intravenous antibiotics for complex appendicitis is non-inferior to 5 days in terms of infectious complications and mortality within 90 days, based on a non-inferiority margin of 7·5%. These findings apply to laparoscopic appendicectomy conducted in a well resourced health-care setting. Adopting this strategy will reduce adverse effects of antibiotics and length of hospital stay. FUNDING: The Netherlands Organization for Health Research and Development.
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Antibacterianos , Apendicite , Humanos , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Encaminhamento e Consulta , Resultado do Tratamento , TelefoneRESUMO
OBJECTIVES: The Hyperview® is a hyperspectral camera, which can be used to assess the microcirculation of patients with peripheral arterial disease (PAD) and/or diabetes mellitus (DM). It measures local tissue oxygenation in concentrations of oxyhemoblobin (OXY), deoxyhemoglobin (DEOXY), and O2-saturation (O2-SAT) in arbitrary units. The aim of this validation study is to assess whether the Hyperview® is able to monitor microcirculatory changes after revascularization in patients with PAD. METHODS: In this prospective observational cohort study, 50 patients with PAD were included who were scheduled for endovascular, hybrid, or open revascularization. The ankle-brachial index (ABI), systolic toe pressure (TP) (in case of DM), and a set of Hyperview® measurements of the plantar region were recorded before and after treatment. Changes in pre- and postoperative measurements were assessed with the paired t-test. RESULTS: Some 38 patients underwent endovascular revascularization and eight patients underwent hybrid or open vascular surgical revascularization. After revascularization, the ABI improved from 0.58 to 0.80 (p < 0.001). OXY increased from 72.6 to 77.8 (p = 0.134). DEOXY decreased from 69.1 to 55.0 (p < 0.001). O2-SAT increased from 51.3 to 58.1 (p < 0.001). TP improved from 50.6 to 61.9 mmHg (p = 0.065) but was measured in only 16 patients. CONCLUSION: The Hyperview® is able to observe changes in the microcirculation after revascularization in terms of DEOXY and O2-SAT. The results of this study are a promising step into the validation of the Hyperview®.
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Imageamento Hiperespectral , Doença Arterial Periférica , Humanos , Microcirculação , Estudos Prospectivos , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/cirurgia , Índice Tornozelo-BraçoRESUMO
BACKGROUND: The role of diverting ileostomy in total mesorectal excision (TME) for rectal cancer with primary anastomosis is debated. The aim of this study is to gain insight in the clinical consequences of a diverting ileostomy, with respect to stoma rate at one year and stoma-related morbidity. METHODS: Patients undergoing TME with primary anastomosis for rectal cancer between 2015 and 2017 in eleven participating hospitals were included. Retrospectively, two groups were compared: patients with or without diverting ileostomy construction during primary surgery. Primary endpoint was stoma rate at one year. Secondary endpoints were severity and rate of anastomotic leakage, overall morbidity rate within thirty days and stoma (reversal) related morbidity. RESULTS: In 353 out of 595 patients (59.3%) a diverting ileostomy was constructed during primary surgery. Stoma rate at one year was 9.9% in the non-ileostomy group and 18.7% in the ileostomy group (p = 0.003). After correction for confounders, multivariate analysis showed that the construction of a diverting ileostomy during primary surgery was an independent risk factor for stoma at one year (OR 2.563 (95%CI 1.424-4.611), p = 0.002). Anastomotic leakage rate was 17.8% in the non-ileostomy group and 17.2% in the ileostomy group (p = 0.913). Overall 30-days morbidity rate was 37.6% in the non-ileostomy group and 56.1% in the ileostomy group (p < 0.001). Stoma reversal related morbidity rate was 17.9%. CONCLUSIONS: The stoma rate at one year was higher in patients with ileostomy construction during primary surgery. The incidence and severity of anastomotic leakage were not reduced by construction of an ileostomy. The morbidity related to the presence and reversal of a diverting ileostomy was substantial.
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Fístula Anastomótica , Neoplasias Retais , Humanos , Fístula Anastomótica/epidemiologia , Fístula Anastomótica/etiologia , Fístula Anastomótica/cirurgia , Estudos Retrospectivos , Neoplasias Retais/cirurgia , Neoplasias Retais/complicações , Anastomose Cirúrgica/efeitos adversos , Anastomose Cirúrgica/métodos , Ileostomia/métodos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgiaRESUMO
OBJECTIVE: To investigate the oncological safety and potential cost savings of selective histopathological examination after appendectomy. BACKGROUND: The necessity of routine histopathological examination after appendectomy has been questioned, but prospective studies investigating the safety of a selective policy are lacking. METHODS: In this multicenter, prospective, cross-sectional study, inspection and palpation of the (meso)appendix was performed by the surgeon in patients with suspected appendicitis. The surgeon's opinion on additional value of histopathological examination was reported before sending all specimens to the pathologist. Main outcomes were the number of hypothetically missed appendiceal neoplasms with clinical consequences benefiting the patient (upper limit two-sided 95% confidence interval below 3:1000 considered oncologically safe) and potential cost savings after selective histopathological examination. RESULTS: Seven thousand three hundred thirty-nine patients were included. After a selective policy, 4966/7339 (67.7%) specimens would have been refrained from histopathological examination. Appendiceal neoplasms with clinical consequences would have been missed in 22/4966 patients. In 5/22, residual disease was completely resected during additional surgery. Hence, an appendiceal neoplasm with clinical consequences benefiting the patient would have been missed in 1.01:1000 patients (upper limit 95% confidence interval 1.61:1000). In contrast, twice as many patients (10/22) would not have been exposed to potential harm due to re-resections without clear benefit, whereas consequences were neither beneficial nor harmful in the remaining seven. Estimated cost savings established by replacing routine for selective histopathological examination were 725,400 per 10,000 patients. CONCLUSIONS: Selective histopathological examination after appendectomy for suspected appendicitis is oncologically safe and will likely result in a reduction of pathologists' workload, less costs, and fewer re-resections without clear benefit.
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Neoplasias do Apêndice , Apendicite , Apêndice , Humanos , Apendicectomia/métodos , Estudos Prospectivos , Estudos Transversais , Apendicite/diagnóstico , Apendicite/cirurgia , Neoplasias do Apêndice/cirurgia , Neoplasias do Apêndice/patologia , Redução de Custos , Apêndice/patologia , Apêndice/cirurgia , Estudos RetrospectivosRESUMO
BACKGROUND: Radiologic imaging can accurately diagnose acute appendicitis, but little is known about its discriminatory capacity between complicated and uncomplicated appendicitis. OBJECTIVE: This study aims to investigate the accuracy of imaging in discriminating complicated from uncomplicated appendicitis. METHODS: Data was used from the prospective, nationwide, observational SNAPSHOT appendicitis database, including patients with suspected acute appendicitis who were planned for an appendectomy. Usage of ultrasound (US), CT, MRI or a combination was recorded. Radiological reports were used to group for complicated or uncomplicated appendicitis. The reference standard was based on operative and pathological findings. Primary outcomes were sensitivity and specificity in discriminating complicated from uncomplicated appendicitis. Secondary outcomes were diagnostic accuracy results per imaging modality and for the subgroups age, BMI, and sex. RESULTS: Preoperative imaging was performed in 1964 patients. In 1434 patients (73%), only US was used; in 109 (6%) patients, only CT was used; and 421 (21%) patients underwent US followed by CT or MRI. Overall, imaging workup as practiced, following the national guideline, had a poor sensitivity for complicated appendicitis of only 35%, although specificity was as high as 93%. For US, accuracy for complicated appendicitis was higher in children than in adults; sensitivity 41.2% vs. 26.4% and specificity 94.6% vs. 93.4%, respectively, p = 0.003. For relevant subgroups such as age, sex and BMI, no other differences in the discriminatory performance were found. CONCLUSION: A diagnostic workup with stepwise imaging, using a conditional CT or MRI strategy, poorly discriminates between complicated and uncomplicated appendicitis in daily practice.
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Apendicite , Doença Aguda , Adulto , Apendicectomia , Apendicite/complicações , Apendicite/diagnóstico por imagem , Apendicite/cirurgia , Criança , Humanos , Estudos Prospectivos , Estudos Retrospectivos , UltrassonografiaRESUMO
BACKGROUND: Little is known about patients with appendicitis presenting at nighttime. It is hypothesized that patients presented at night more frequently have a complicated (gangrenous or perforated) appendicitis and therefore develop more postoperative complications. METHODS: In this study data were used from the nationwide, prospective SNAPSHOT study appendicitis, including 1975 patients undergoing surgery for suspected appendicitis. This study included only adults. Two primary outcomes were defined: (A) The proportion of patients with complicated appendicitis and (B) the proportion of patients with a complication postoperatively presenting during daytime versus nighttime period. Analysis for both complicated and uncomplicated appendicitis was performed, and a multivariate model was used to correct for baseline characteristics and time to surgery. RESULTS: In total, 1361 adult patients with appendicitis were analyzed. Both at nighttime and at daytime, 34% had complicated appendicitis. In patients presenting in the daytime, 12.1% developed a postoperative complication versus 18.6% for presentation at night (p = 0.008). In a multivariate analysis, the risk for a postoperative complication when presenting at night was significantly increased (adjusted OR 1.74; 95% CI 1.14-2.66, p = 0.01). Surgery within eight hours after presentation does not lower this risk (adjusted OR 1.37; 95% CI 0.97-1.95, p = 0.078). CONCLUSION: Complicated appendicitis is seen as frequently during the day as at nighttime. For patients who present at nighttime with acute appendicitis, the risk of a postoperative complication is higher compared with a presentation at daytime. In multivariate analysis, nighttime presentation but not surgery within 8 h after presentation is independently associated with postoperative complication risk.
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INTRODUCTION: Growing evidence is showing that complicated and uncomplicated appendicitis are two different entities that may be treated differently. A correct diagnosis of the type of appendicitis is therefore essential. The Scoring system of Appendicitis Severity (SAS) combines clinical, laboratory and imaging findings. The SAS rules out complicated appendicitis in 95% (negative predictive value, NPV) and detects 95% (sensitivity) of patients with complicated appendicitis in adults suspected of acute appendicitis. However, this scoring system has not yet been validated externally. In this study, we aim to provide a prospective external validation of the SAS in a new cohort of patients with clinical suspicion of appendicitis. We will optimise the score when necessary. METHODS AND ANALYSIS: The SAS will be validated in 795 consecutive adult patients diagnosed with acute appendicitis confirmed by imaging. Data will be collected prospectively in multiple centres. The predicted diagnosis based on the SAS score will be compared with the combined surgical and histological diagnosis. Diagnostic accuracy for ruling out complicated appendicitis will be calculated. If the SAS does not reach a sensitivity and NPV of 95% in its present form, the score will be optimised. After optimisation, a second external validation will be performed in a new group of 328 patients. Furthermore, the diagnostic accuracy of the clinical perspective of the treating physician for differentiation between uncomplicated and complicated appendicitis and the patient's preferences for different treatment options will be assessed. ETHICS AND DISSEMINATION: Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (reference W19_416 # 19.483). Because of the observational nature of this study, the study does not fall under the scope of the Medical Research Involving Human Subjects Act. Results will be presented in peer-reviewed journals. This protocol is submitted for publication before analysis of the results.
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Apendicite , Doença Aguda , Adulto , Apendicite/complicações , Apendicite/diagnóstico , Apendicite/cirurgia , Estudos de Coortes , Humanos , Estudos Observacionais como Assunto , Valor Preditivo dos Testes , Estudos ProspectivosRESUMO
BACKGROUND: There is ongoing debate concerning the necessity of routine histopathological examination following cholecystectomy. In order to reduce the pathology workload and save costs, a selective approach has been suggested, but evidence regarding its oncological safety is lacking. METHODS: In this multicentre, prospective, cross-sectional study, all gallbladders removed for gallstone disease or cholecystitis were systematically examined by the surgeon for macroscopic abnormalities indicative of malignancy. Before sending all specimens to the pathologist, the surgeon judged whether histopathological examination was indicated. The main outcomes were the number of patients with hypothetically missed malignancy with clinical consequences (upper limit two-sided 95 per cent c.i. below 3:1000 considered oncologically safe) and potential cost savings of selective histopathological examination. RESULTS: Twenty-two (2.19:1000) of 10 041 specimens exhibited malignancy with clinical consequences. In case of a selective policy, surgeons would have held back 7846 of 10041 (78.1 per cent) gallbladders from histopathological examination. Malignancy with clinical consequences would have been missed in seven of 7846 patients (0.89:1000, upper limit 95% c.i. 1.40:1000). No patient benefitted from the clinical consequences, while two were harmed (futile additional surgery). Of 15 patients in whom malignancy with clinical consequences would have been diagnosed, one benefitted (residual disease radically removed), two potentially benefitted (palliative systemic therapy), and four experienced harm (futile additional surgery). Estimated cost savings established by replacing routine for selective histopathological examination were 703 500 per 10 000 patients. CONCLUSION: Selective histopathological examination following cholecystectomy is oncologically safe and could reduce pathology workload, costs, and futile re-resections.
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Neoplasias da Vesícula Biliar , Colecistectomia , Redução de Custos , Estudos Transversais , Neoplasias da Vesícula Biliar/patologia , Humanos , Estudos ProspectivosRESUMO
BACKGROUND: Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use. METHODS: This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2â g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay. RESULTS: Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay. CONCLUSION: Omitting antibiotic prophylaxis is not recommended.
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Antibioticoprofilaxia , Infecções Bacterianas/prevenção & controle , Cefazolina/uso terapêutico , Colecistectomia Laparoscópica/efeitos adversos , Colecistite Aguda/cirurgia , Infecção da Ferida Cirúrgica/prevenção & controle , Bile/microbiologia , Conversão para Cirurgia Aberta , Estudos de Equivalência como Asunto , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Fatores de RiscoRESUMO
Background: The effect of diagnosing appendicitis at re-assessment on post-operative outcomes is not clear. This study aims to compare patients diagnosed with appendicitis at initial presentation versus patients who were diagnosed at re-assessment. Patients and Methods: Data from the Dutch SNAPSHOT appendicitis collaborative was used. Patients with appendicitis who underwent appendectomy were included. Effects of diagnosis at re-assessment were compared with diagnosis at initial presentation. Primary outcomes were the proportion of patients with complicated appendicitis and the post-operative complication rate. Results: Of 1,832 patients, 245 (13.4%) were diagnosed at re-assessment. Re-assessed patients had a post-operative complication rate comparable to those diagnosed with appendicitis at initial presentation (15.1% vs. 12.7%; p = 0.29) and no substantial difference was found in the proportion of patients with complicated appendicitis (27.9% vs. 33.5%; p = 0.07). For patients with complicated appendicitis, more post-operative complications were seen if diagnosed at re-assessment than if diagnosed initially (38.2% vs. 22.9%; p = 0.006). Conclusions: For patients in whom appendicitis was not diagnosed at first presentation, but at re-assessment, both the proportion of complicated appendicitis and the post-operative complication rate were comparable to those who were diagnosed with appendicitis at initial presentation. However, re-assessed patients with complicated appendicitis encountered more post-operative complications.
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Apendicite , Laparoscopia , Doença Aguda , Apendicectomia/efeitos adversos , Apendicite/complicações , Apendicite/diagnóstico , Apendicite/cirurgia , Humanos , Tempo de Internação , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Estudos RetrospectivosRESUMO
OBJECTIVE: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia. SUMMARY BACKGROUND DATA: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing). METHODS: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic. RESULTS: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome. CONCLUSIONS: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.
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Herniorrafia/métodos , Hérnia Incisional/cirurgia , Períneo/cirurgia , Complicações Pós-Operatórias/cirurgia , Protectomia/efeitos adversos , Telas Cirúrgicas , Técnicas de Fechamento de Ferimentos , Adulto , Feminino , Seguimentos , Humanos , Hérnia Incisional/etiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Qualidade de Vida , Neoplasias Retais/cirurgia , Fatores de Tempo , CicatrizaçãoRESUMO
OBJECTIVES: The Hyperview® is a novel camera that applies hyperspectral imaging to project local concentrations of oxyhaemoglobin (OXY), deoxyhaemoglobin (DEOXY) and O2-saturation (O2-SAT) in a map. In this pilot validation study, we assessed inter - and intra-observer agreement for measuring OXY, DEOXY and O2-SAT in healthy participants. METHODS: The plantar region of the right foot was assessed with the Hyperview® in 50 healthy participants. Two consecutive pictures were taken by the same observer, followed by two images by a second observer. Measurements were performed without and with standardization (a static device for both the foot and the Hyperview camera). Inter- and intra-observer agreements were expressed as Intraclass Correlation coefficients (ICC) with their 95% confidence interval (CI). A score <0.40 indicates poor agreement, 0.40-0.59 fair, 0.60-0.74 good and 0.75-1.00 excellent agreement. Bland and Altman plots were also generated. RESULTS: Without standardization, the ICC values between the observers for OXY, DEOXY and O2-SAT ranged from 0.70 to 0.83. The intra-observer agreement of both observers ranged from 0.36 to 0.83. With standardization, the ICC values between the observers ranged from 0.80 to 0.82 and intra-observer agreement varied from 0.75 to 0.92. Four Bland and Altman plots were generated of the measurements of OXY by observers 1 and 2. CONCLUSIONS: When standardization is used, the Hyperview® camera is a reliable device with excellent intra- and inter-observer agreements for the assessment of OXY, DEOXY and O2-SAT. In future research, the inter- and intra-observer agreements of the camera should be investigated in patients with diabetes and/or peripheral arterial disease.
Assuntos
Doença Arterial Periférica , Voluntários Saudáveis , Humanos , Variações Dependentes do Observador , Projetos Piloto , Reprodutibilidade dos TestesRESUMO
BACKGROUND: The superiority of robot-assisted over laparoscopic total mesorectal excision has not been proven. Most studies do not consider the learning curve while comparing the surgical technique. OBJECTIVE: This study aims to compare laparoscopic with robot-assisted total mesorectal excision performed by surgeons who completed the learning curve of the technique. DESIGN: This is a multicenter retrospective propensity score-matched analysis. SETTINGS: The study was performed in 2 large, dedicated robot-assisted hospitals and 5 large, dedicated laparoscopic hospitals. PATIENTS: Patients were included if they underwent a robot-assisted or laparoscopic total mesorectal excision for rectal cancer with curative intent at a dedicated center for the minimally invasive technique between January 1, 2015, and December 31, 2017. INTERVENTIONS: We compared robot-assisted with laparoscopic total mesorectal excision. MAIN OUTCOME MEASURES: The main outcome was conversion to laparotomy during surgery. Secondary outcomes were postoperative morbidity and positive circumferential resection margin. RESULTS: A total of 884 patients were included and, after matching, 315 patients per treatment group remained. Conversion was similar between laparoscopic and robot-assisted total mesorectal excision (4.4% vs 2.5% (p = 0.20)). Positive circumferential resection margin was equal (3.2% vs 4.4% (p = 0.41)). Overall morbidity was comparable as well, although a lower rate of wound infections was observed in the robot-assisted group (5.7% vs 1.9% (p = 0.01)). More primary anastomoses were constructed in the robot-assisted group (50.8% vs 68.3% (p < 0.001)). Finally, more open procedures were performed in dedicated laparoscopic centers, with an overrepresentation of cT4N+ tumors in this group. LIMITATIONS: This is a retrospective multicenter cohort; however, propensity score matching was applied to control for confounding by indication. CONCLUSIONS: Robot-assisted and laparoscopic total mesorectal excision are equally safe in terms of short-term outcomes. However, with the robot-assisted approach, more primary anastomoses were constructed, and a lower wound infection rate was observed. See Video Abstract at http://links.lww.com/DCR/B677.ESCISIÓN MESORRECTAL TOTAL ASISTIDA POR ROBOT VERSUS ESCISIÓN MESORRECTAL TOTAL LAPAROSCÓPICA: UNA PUNTUACIÓN DE PROPENSIÓN RETROSPECTIVA ANÁLISIS DE COHORTES EMPAREJADAS EN CENTROS EXPERIMENTADOS. ANTECEDENTES: No se ha demostrado la superioridad de la escisión mesorrectal total asistida por robot sobre la laparoscópica. La mayoría de los estudios no tienen en cuenta la curva de aprendizaje al comparar la técnica quirúrgica. OBJETIVO: Este estudio tiene como objetivo comparar la escisión mesorrectal total laparoscópica con la asistida por robot realizada por cirujanos que completaron la curva de aprendizaje de la técnica. DISEO: Este es un análisis multicéntrico retrospectivo emparejado por puntuación de propensión. AJUSTES: El estudio se realizó en dos grandes hospitales dedicados asistidos por robots y cinco grandes hospitales laparoscópicos dedicados. PACIENTES: Se incluyeron pacientes que se sometieron a escisión mesorrectal total asistida por robot o laparoscópica para cáncer de recto con intención curativa, en un centro dedicado a la técnica mínimamente invasiva entre el 1 de enero de 2015 y el 31 de diciembre de 2017. INTERVENCIONES: Comparamos la escisión mesorrectal total asistida por robot con la laparoscópica. PRINCIPALES MEDIDAS DE RESULTADO: El principal resultado fue la conversión a laparotomía durante la cirugía. Los resultados secundarios fueron la morbilidad posoperatoria y el margen circunferencial positivo. RESULTADOS: Se incluyó a un total de 884 pacientes y, después de emparejar, quedaron 315 pacientes por grupo de tratamiento. La conversión fue similar entre la escisión mesorrectal total laparoscópica y asistida por robot (4,4% frente a 2,5% [p = 0,20]). El margen de resección circunferencial positivo fue igual (3,2% vs 4,4% [p = 0,41]). La morbilidad general también fue comparable, aunque se observó una menor tasa de infecciones de heridas en el grupo asistido por robot (5,7% frente a 1,9% [p = 0,01]). Se construyeron más anastomosis primarias en el grupo asistido por robot (50,8% frente a 68,3% [p < 0,001]). Finalmente, se realizaron procedimientos más abiertos en centros laparoscópicos dedicados, con una sobrerrepresentación de tumores cT4N + en este grupo. LIMITACIONES: Ésta es una cohorte multicéntrica retrospectiva; sin embargo, se aplicó el emparejamiento por puntuación de propensión para controlar los factores de confusión por indicación. CONCLUSIONES: La escisión mesorrectal total asistida por robot y laparoscópica son igualmente seguras en términos de resultados a corto plazo. Sin embargo, con el abordaje asistido por robot, se construyeron más anastomosis primarias y se observó una menor tasa de infección de la herida. Consulte Video Resumen en http://links.lww.com/DCR/B677. (Traducción-Dr. Gonzalo Hagerman).
Assuntos
Adenocarcinoma/cirurgia , Laparoscopia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Protectomia/efeitos adversos , Neoplasias Retais/cirurgia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Adenocarcinoma/mortalidade , Adenocarcinoma/patologia , Idoso , Competência Clínica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Neoplasias Retais/mortalidade , Neoplasias Retais/patologia , Estudos RetrospectivosRESUMO
AIM: This study aimed to quantify displacement of urogenital organs after abdominoperineal resection (APR), and to explore patient and treatment characteristics associated with displacement. METHOD: Patients from 16 centres who underwent APR for primary or recurrent rectal cancer (2001-2018) with evaluable preoperative and 6-18 months postoperative radiological imaging were included in the study. Anatomical landmarks on sagittal images were related to a coordinate system based on reference lines between fixed bony structures and absolute displacements were calculated using the Pythagorean theorem. Rotation of landmarks was measured relative to a pubic-S5 reference line. RESULTS: There were 248 patients included of which 171 were men and 77 women. The median displacement of the internal urethral orifice was 25 mm in men (maximum 65), and 17 mm in women (maximum 50). Rotation of the internal urethral orifice was in a caudal direction in 160/170 (94%) of men and 65/73 (89%) of women, with a median of 32 degrees (maximum 85) and 33 degrees (maximum 83), respectively. Displacements of the posterior bladder wall, distal end of prostatic urethra and cervix were significantly correlated with the internal urethral orifice. In linear regression analysis, biological mesh reconstruction of the pelvic floor and visceral interposition were significantly associated with increased displacement of the internal urethral orifice, and female gender and any filling of the presacral space with decreased displacement. CONCLUSIONS: Substantial absolute displacement and rotation of urogenital organs after APR for rectal cancer were observed, but with high variability among both men and women, and being significantly associated with reconstructive interventions.
Assuntos
Protectomia , Neoplasias Retais , Feminino , Humanos , Masculino , Recidiva Local de Neoplasia , Diafragma da Pelve , Períneo/cirurgia , Protectomia/efeitos adversos , Neoplasias Retais/cirurgia , UretraRESUMO
BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.