RESUMO
BACKGROUND: Recently, positive circumferential resection margin has been found to be an indicator of advanced disease with a high risk of distant recurrence rather than local recurrence. OBJECTIVE: The study aimed to analyze the prognostic impact of the circumferential resection margin on long-term oncological outcomes in patients with rectal cancer. DESIGN: This was a multicenter, propensity score-matched (2:1) analysis comparing the positive and negative circumferential resection margins. SETTINGS: The study was conducted at 5 high-volume centers in Spain. PATIENTS: Patients who underwent total mesorectal excision with curative intent for middle-low rectal cancer between 2006 and 2014 were included. MAIN OUTCOME MEASURES: The main outcomes were local recurrence, distant recurrence, overall survival, and disease-free survival. RESULTS: The unmatched initial cohort consisted of 1599 patients, of whom 4.9% had a positive circumferential resection margin. After matching, 234 patients were included (156 with a negative circumferential margin and 78 with a positive circumferential margin). The median follow-up period was 52.5 (22.0-69.5) months. Local recurrence was significantly higher in patients with a positive circumferential margin (33.3% vs 11.5%; p < 0.001). Distant recurrence was similar in both groups (46.2% vs 42.3%; p = 0.651). There were no statistically significant differences in 5-year overall survival (48.6% vs 43.6%; p = 0.14). Disease-free survival was lower in patients with a positive circumferential margin (36.1% vs 52.3%; p = 0.026). LIMITATIONS: This study was limited by its retrospective design. The different neoadjuvant treatment options were not included in the propensity score. CONCLUSIONS: The positive circumferential resection margin was associated with a higher local recurrence rate and worse disease-free survival in comparison with the negative circumferential resection margin. However, the positive circumferential resection margin was not a prognostic indicator of distant recurrence and overall survival. See Video Abstract at http://links.lww.com/DCR/B950 . VALOR PRONSTICO DEL MARGEN DE RESECCIN CIRCUNFERENCIAL DESPUS DE LA CIRUGA CURATIVA PARA EL CNCER DE RECTO UN ANLISIS MULTICNTRICO EMPAREJADO POR PUNTAJE DE PROPENSIN: ANTECEDENTES:En los últimos años, se ha encontrado que el margen de resección circunferencial positivo es un indicador de enfermedad avanzada con alto riesgo de recurrencia a distancia más que de recurrencia local.OBJETIVO:El objetivo fue analizar el impacto pronóstico del margen de resección circunferencial sobre la recidiva local, a distancia y las tasas de supervivencia en pacientes con cáncer de recto.DISEÑO:Este fue un análisis multicéntrico emparejado por puntaje de propensión 2: 1 que comparó el margen de resección circunferencial positivo y negativo.AJUSTES:El estudio se realizó en 5 centros Españoles de alto volumen.PACIENTES:Se incluyeron pacientes sometidos a escisión total de mesorrecto con intención curativa por cáncer de recto medio-bajo entre 2006-2014. Las características clínicas e histológicas se utilizaron para el emparejamiento.PRINCIPALES MEDIDAS DE RESULTADO:Los resultadoes principales fueron la recurrencia local, la recurrencia a distancia, la supervivencia global y libre de enfermedad.RESULTADOS:La cohorte inicial no emparejada consistió en 1599 pacientes; El 4,9% tuvo un margen de resección circunferencial positivo. Tras el emparejamiento se incluyeron 234 pacientes (156 con margen circunferencial negativo y 78 con margen circunferencial positivo). La mediana del período de seguimiento fue de 52,5 meses (22,0-69,5). La recurrencia local fue significativamente mayor en pacientes con margen circunferencial positivo, 33,3% vs 11,5% [HR 3,2; IC 95%: 1,83-5,43; p < 0,001]. La recidiva a distancia fue similar en ambos grupos (46,2 % frente a 42,3 %) [HR 1,09, IC 95 %: 0,78-1,90; p = 0,651]. No hubo diferencias significativas en la supervivencia global a 5 años (48,6 % frente a 43,6 %) [HR 1,09, IC 95 %: 0,92-1,78; p = 0,14]; La supervivencia libre de enfermedad fue menor en pacientes con margen circunferencial positivo, 36,1% vs 52,3% [HR 1,5; IC 95%: 1,05-2,06; p = 0,026].LIMITACIONES:Este estudio estuvo limitado por el diseño retrospectivo. Las diferentes opciones de tratamientos neoadyuvantes no se han incluido en la puntuación de propensión.CONCLUSIONES:El margen de resección circunferencial positivo se asocia con una mayor tasa de recurrencia local y peor supervivencia libre de enfermedad en comparación con el margen de resección circunferencial negativo. Sin embargo, el margen de resección circunferencial positivo no fue un indicador pronóstico de recidiva a distancia ni de supervivencia global. Consulte el Video del Resumen en http://links.lww.com/DCR/B950 . (Traducción- Dr. Yesenia Rojas-Khalil ).
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Neoplasias Retais , Humanos , Prognóstico , Pontuação de Propensão , Estudos Retrospectivos , Neoplasias Retais/patologia , Reto/cirurgia , Margens de Excisão , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/patologia , Estadiamento de NeoplasiasRESUMO
INTRODUCTION: the goal of this study was to compare the oncological results (local recurrence, metastasis and overall survival) obtained by the Proyecto Docente del Cáncer de Recto of the Spanish Association of Surgeons (AEC) (Proyecto Vikingo, PV) in Catalonia versus the rest of Spanish autonomous communities. METHODS: the PV database includes 4,508 patients who underwent a curative resection between March 2006 and December 2010, from the first 59 hospitals included in PV; 1,163 were from Catalonia and 3,345 were from the rest of Spain. There was a minimum follow-up of five years. RESULTS: in Catalonia, the five-year cumulative incidence was 8% (95% CI: 6.4-9.9) for local recurrence, 17.7% (95% CI: 15.4-20.2) for metastasis and 75% (95% CI: 72.4-77.7) for overall survival. In the rest of autonomous communities, these figures were 7% (95% CI: 6.2-8.2) for local recurrence, 22.3% (95% CI: 20.7-23.9) for metastasis, and 71% (95% CI: 69.4-72.9) for overall survival. Variables associated with tumor recurrence in PV included Hartmann's procedure, intraoperative perforation and circumferential margin involvement. CONCLUSION: the results obtained by the Proyecto Docente del Cáncer de Recto were homogeneous between Catalonia and the rest of the autonomous communities.
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Neoplasias Retais/cirurgia , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos do Sistema Digestório/educação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Recidiva Local de Neoplasia/epidemiologia , Neoplasias Retais/mortalidade , Neoplasias Retais/patologia , Espanha , Taxa de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: The optimal treatment strategy for older rectal cancer patients remains unclear. The current study aimed to compare treatment and survival of rectal cancer patients aged 80+. METHODS: Patients of ≥80 years diagnosed with rectal cancer between 2001 and 2010 were included. Population-based cohorts from Belgium (BE), Denmark (DK), the Netherlands (NL), Norway (NO) and Sweden (SE) were compared side by side for neighbouring countries on treatment strategy and 5-year relative survival (RS), adjusted for sex and age. Analyses were performed separately for stage I-III patients and stage IV patients. RESULTS: Overall, 19 634 rectal cancer patients were included. For stage I-III patients, 5-year RS varied from 61.7% in BE to 72.3% in SE. Proportion of preoperative radiotherapy ranged between 7.9% in NO and 28.9% in SE. For stage IV patients, 5-year RS differed from 2.8% in NL to 5.6% in BE. Rate of patients undergoing surgery varied from 22.2% in DK to 40.8% in NO. CONCLUSIONS: Substantial variation was observed in the 5-year relative survival between European countries for rectal cancer patients aged 80+, next to a wide variation in treatment, especially in the use of preoperative radiotherapy in stage I-III patients and in the rate of patients undergoing surgery in stage IV patients.
Assuntos
Procedimentos Cirúrgicos do Sistema Digestório/estatística & dados numéricos , Radioterapia Adjuvante/estatística & dados numéricos , Neoplasias Retais/terapia , Terapia Combinada/estatística & dados numéricos , Europa (Continente) , Feminino , Humanos , Masculino , Estadiamento de Neoplasias , Neoplasias Retais/mortalidade , Neoplasias Retais/patologia , Sistema de Registros , Análise de Sobrevida , Resultado do TratamentoRESUMO
INTRODUCTION: The objective of this observational, prospective, multicenter and multilevel study was to evaluate the oncological outcomes (local recurrence, metastasis and overall survival) of the Rectal Cancer Project of the Spanish Association of Surgeons (AEC) 10 years after its initiation, comparing the results with Scandinavian registries. METHODS: The AEC teaching project database includes 17,620 patients to date, of which 4,508 were operated on with a potentially curative resection between March 2006 and December 2010. All of them come from the first 59 hospitals included in the project, and therefore followed for at least 5 years, and are the subject of the present study. RESULTS: The cumulative incidence of local recurrence was 7.3 (95% CI: 8.2-6.5), metastasis 21.0 (CI 95%: 22.4-19.7) and overall survival 72.3 (CI 95%: 80.3-77.6). The multilevel regression analysis with the hospital variable as a random effect, showed a significant variation among the hospitals for the cancer outcome variables: general survival, local recurrence and metastasis (δ2=0.053). CONCLUSIONS: This study indicates that the results observed in the AEC' Rectal Cancer Project are inferior than those observed in the Scandinavian registries that we tried to emulate and that this is attributable to the variability of practice in some centers.
Assuntos
Neoplasias Retais/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Recidiva Local de Neoplasia/epidemiologia , Estudos Prospectivos , Neoplasias Retais/mortalidade , Neoplasias Retais/patologia , Sistema de Registros , Países Escandinavos e Nórdicos , Espanha , Taxa de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Studies focused on postoperative outcome after oncologic right colectomy are lacking. The main objective was to determine pre-/intraoperative risk factors for anastomotic leak after elective right colon resection for cancer. Secondary objectives were to determine risk factors for postoperative morbidity and mortality. METHODS: Fifty-two hospitals participated in this prospective, observational study (September 2011-September 2012), including 1102 patients that underwent elective right colectomy. Forty-two pre-/intraoperative variables, related to patient, tumor, surgical procedure, and hospital, were analyzed as potential independent risk factors for anastomotic leak and postoperative morbidity and mortality. RESULTS: Anastomotic leak was diagnosed in 93 patients (8.4 %), and 72 (6.5 %) of them needed radiological or surgical intervention. Morbidity, mortality, and wound infection rates were 29.0, 2.6, and 13.4 %, respectively. Preoperative serum protein concentration was the only independent risk factor for anastomotic leak (p < 0.0001, OR 0.6 per g/dL). When considering only clinically relevant anastomotic leaks, stapled technique (p = 0.03, OR 2.1) and preoperative serum protein concentration (p = 0.004, OR 0.6 g/dL) were identified as the only two independent risk factors. Age and preoperative serum albumin concentration resulted to be risk factors for postoperative mortality. Male gender, pulmonary or hepatic disease, and open surgical approach were identified as risk factors for postoperative morbidity, while male gender, obesity, intraoperative complication, and end-to-end anastomosis were risk factors for wound infection. CONCLUSIONS: Preoperative nutritional status and the stapled anastomotic technique were the only independent risk factors for clinically relevant anastomotic leak after elective right colectomy for cancer. Age and preoperative nutritional status determined the mortality risk, while laparoscopic approach reduced postoperative morbidity.
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Fístula Anastomótica/etiologia , Fístula Anastomótica/mortalidade , Colectomia/efeitos adversos , Neoplasias Colorretais/cirurgia , Idoso , Idoso de 80 Anos ou mais , Demografia , Feminino , Humanos , Cuidados Intraoperatórios , Masculino , Morbidade , Análise Multivariada , Período Pós-Operatório , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: Postoperative ileus is a common problem with significant clinical and economic consequences. We hypothesized that Gastrografin may have therapeutic utility by accelerating the recovery of postoperative ileus after colorectal surgery. The aim of this trial was to study the impact of oral Gastrografin administration on postoperative prolonged ileus (PPI) after elective colorectal surgery. METHODS: The main endpoint of this randomized, double-blinded, controlled trial was time of resolution of PPI. The secondary endpoints were overall hospital length of stay, time to start oral intake, time to first passage of flatus or stools, time of need of nasogastric tube, and need of parenteral nutrition. Included criteria were patients older than 18 years, operated for colonic neoplasia, inflammatory bowel disease, or diverticular disease. There were two treatments: Gastrografin administration and placebo. The sample size was calculated taking into account the average length of postoperative ileus after colorectal resection until tolerance to oral intake. Statistical analysis showed that 29 subjects in each group were needed. RESULTS: Twenty-nine patients per group were randomized. Groups were comparable for age, gender, ASA Physical Status Classification System, stoma construction, and surgical technique. No statistical differences were observed in mean time to resolution between the two groups, 9.1 days (CI 95%, 6.51-11.68) in Gastrografin group versus 10.3 days (CI 6.96-10.29) in Placebo group (P = 0.878). Even if not statistically significant, time of resolution of PPI, overall length of stay, time of need of nasogastric tube, and time to tolerance of oral intake were shorter in the G group. CONCLUSIONS: Gastrografin does not accelerate significantly the recovery of prolonged postoperative ileus after elective colorectal resection when compared with placebo. However, it seems to clinically improve all the analyzed variables.
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Cirurgia Colorretal/efeitos adversos , Diatrizoato de Meglumina/uso terapêutico , Fármacos Gastrointestinais/uso terapêutico , Íleus/tratamento farmacológico , Idoso , Método Duplo-Cego , Feminino , Humanos , Íleus/etiologia , Intubação Gastrointestinal , Masculino , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias , Fatores de TempoRESUMO
OBJECTIVE: This multicentre observational study aimed to compare outcomes of anterior resection (AR) and abdominal perineal resection (APR) in patients treated for rectal cancer. METHODS: Between March 2006 and March 2009 a cohort of 1,598 patients diagnosed with low and mid rectal cancer were operated on in the first 38 hospitals included in the Spanish Rectal Cancer Project. In 1,343 patients the procedure was considered curative. Clinical and outcome results were analysed in relation to the type of surgery performed. All patients were included in the analysis of clinical results. The analysis of outcomes was performed only on patients treated by a curative procedure. RESULTS: Of the 1,598 patients, 1,139 (71.3%) underwent an AR and 459 (28.7%) an APR. In 1,343 patients the procedure was performed with curative intent; from these 973 (72.4%) had an AR and 370 (27.6%) an APR. There were no differences between AR and APR in mortality (29 vs. 18 patients; P=.141). After a median follow up of 60.0 [49.0-60.0] months there were no differences in local recurrence (HR 1.68 [0.87-3.23]; P=.12), metastases (HR 1.31 [0.98-1.76]; P=.064). However, overall survival was worse after APR (HR 1.37 [1.00-1.86]; P=.048). CONCLUSION: This study did not identify abdominoperineal excision as a determinant of local recurrence or metastases. However, patients treated by this operation have a decreased overall survival.
Assuntos
Neoplasias Retais/cirurgia , Idoso , Procedimentos Cirúrgicos do Sistema Digestório/métodos , Feminino , Humanos , Masculino , Resultado do TratamentoRESUMO
OBJECTIVE: We compare the results of 2 different strategies for the management of patients with uncomplicated left colonic diverticulitis and to analyze differences in quality of life and economic costs. BACKGROUND: The most frequent standard management of acute uncomplicated diverticulitis still is hospital admission both in Europe and United States. METHODS: This multicenter, randomized controlled trial included patients older than 18 years with acute uncomplicated diverticulitis. All the patients underwent abdominal computed tomography. There were 2 strategies of management: hospitalization (group 1) and outpatient (group 2). The first dose of antibiotic was given intravenously to all patients in the emergency department and then group 1 patients were hospitalized whereas patients in group 2 were discharged. The primary end point was the treatment failure rate of the outpatient protocol and need for hospital admission. The secondary end points included quality-of-life assessment and evaluation of costs. RESULTS: A total of 132 patients were randomized: 4 patients in group 1 and 3 patients in group 2 presented treatment failure without differences between the groups (P=0.619). The overall health care cost per episode was 3 times lower in group 2, with savings of 1124.70 per patient. No differences were observed between the groups in terms of quality of life. CONCLUSIONS: Outpatient treatment is safe and effective in selected patients with uncomplicated acute diverticulitis. Outpatient treatment allows important costs saving to the health systems without negative influence on the quality of life of patients with uncomplicated diverticulitis. Trial registration ID: EudraCT number 2008-008452-17.
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Doença Diverticular do Colo/terapia , Adulto , Idoso , Assistência Ambulatorial/economia , Assistência Ambulatorial/estatística & dados numéricos , Doença Diverticular do Colo/economia , Feminino , Custos de Cuidados de Saúde , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Espanha , Resultado do TratamentoRESUMO
Faecal incontinence (FI) is a major health problem, both for individuals and for health systems. It is obvious that, for all these reasons, there is widespread concern for healing it or, at least, reducing as far as possible its numerous undesirable effects, in addition to the high costs it entails. There are different criteria for the diagnostic tests to be carried out and the same applies to the most appropriate treatment, among the numerous options that have proliferated in recent years, not always based on rigorous scientific evidence. For this reason, the Spanish Association of Coloproctology (AECP) proposed to draw up a consensus to serve as a guide for all health professionals interested in the problem, aware, however, that the therapeutic decision must be taken on an individual basis: patient characteristics/experience of the care team. For its development it was adopted the Nominal Group Technique methodology. The Levels of Evidence and Grades of Recommendation were established according to the criteria of the Oxford Centre for Evidence-Based Medicine. In addition, expert recommendations were added briefly to each of the items analysed.
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Terapia por Estimulação Elétrica , Incontinência Fecal , Humanos , Terapia por Estimulação Elétrica/métodos , Incontinência Fecal/diagnóstico , Incontinência Fecal/terapia , Canal Anal , Medicina Baseada em EvidênciasRESUMO
INTRODUCTION: Neoadjuvant chemo-radiotherapy is the treatment of choice for rectal cancer in order to reduce local recurrence. Patients with a pathological complete response (PCR) have a better prognosis. The aim of this study was to determine the influence of PCR on the oncological outcomes in our patients. METHODS: All patients with stage ii/iii rectal cancer treated with neoadjuvant chemo-radiotherapy and radical resection between 2007 and 2011 were identified from a prospective database, and grouped based on whether they achieved PCR or not (non-PCR). Clinical, histological and oncological outcome data were compared. RESULTS: A total of 162 patients were included (62% men), with a mean age of 65 years. In terms of pre-operative TNM staging, 82 patients (50%) were T2, 75 (46%) were T3, and 5 (3%) were T4. Forty-two patients (25%) were N1, and 87 (53%) were N2. Low anterior resection and abdominoperineal resection were performed in 125 (77%) and 25 (15%) patients. Forty-three patients (26.5%) had postoperative morbidity. PCR was achieved in 19 patients (11.7%). After a median follow-up of 26 months, there are no recurrences in the PCR group, and in the non-PCR group, local recurrence was 1.4% (P=.78), and distant metastasis was 8.4% (P=.21). Overall survival (P=.39) and survival free of diseases (P=.23) were better in the PCR group, but the differences were not significant. CONCLUSION: Patients with pathological complete response have better oncological outcome.
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Adenocarcinoma/terapia , Terapia Neoadjuvante , Neoplasias Retais/terapia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Resultado do TratamentoRESUMO
INTRODUCTION: Colonic volvulus (CV) is an uncommon disease in our country, which may present clinically as an intestinal obstruction or occlusion. Its diagnosis and therapeutic management remains controversial. The objective of this article is to present our series, analyse the results and establish a therapeutic approach to decrease the recurrence of the volvulus. MATERIAL AND METHODS: A retrospective, descriptive study of patients diagnosed with CV between January 1997 and December 2009. RESULTS: The study included 54 patients, with a mean age of 74 years, who had a total of 89 CV episodes. There was associated disease in 70% of the cases, which included 44% with constipation and 53% with neurological diseases. The volvulus was located in the sigmoid in 87% of cases and in the right colon in 13%. The large majority (92%) of cases had intestinal obstruction. Endoscopic treatment was effective in 61% and urgent surgery was performed in 31% of the cases, and in 40% of the first episodes of CV. There was recurrence of volvulus in 62% of cases treated with surgery, and surgery was performed in 72% of these. In the whole series, surgery was performed in 35 cases (64%), with sigmoidectomy with primary anastomosis being the technique most employed. The overall mortality of the series was 7 cases (12%), with 16% being in cases of surgery due to recurrence. CONCLUSIONS: The diagnostic technique and initial treatment of CV is endoscopic decompression. Early elective surgery prevents the high recurrence rate associated with higher mortality.
Assuntos
Doenças do Colo/cirurgia , Volvo Intestinal/cirurgia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Doenças do Colo Sigmoide/cirurgiaRESUMO
INTRODUCTION: Preoperative treatment and adequate surgery increase local control in rectal cancer. However, modalities and indications for neoadjuvant treatment may be controversial. Aim of this study was to assess the trends of preoperative treatment and outcomes in patients with rectal cancer included in the Rectal Cancer Registry of the Spanish Associations of Surgeons. METHOD: This is a STROBE-compliant retrospective analysis of a prospective database. All patients operated on with curative intention included in the Rectal Cancer Registry were included. Analyses were performed to compare the use of neoadjuvant/adjuvant treatment in three timeframes: I)2006-2009; II)2010-2013; III)2014-2017. Survival analyses were run for 3-year survival in timeframes I-II. RESULTS: Out of 14,391 patients,8871 (61.6%) received neoadjuvant treatment. Long-course chemo/radiotherapy was the most used approach (79.9%), followed by short-course radiotherapy⯱â¯chemotherapy (7.6%). The use of neoadjuvant treatment for cancer of the upper third (15-11â¯cm) increased over time (31.5%vs 34.5%vs 38.6%,pâ¯=â¯0.0018). The complete regression rate slightly increased over time (15.6% vs 16% vs 18.5%; pâ¯=â¯0.0093); the proportion of patients with involved circumferential resection margins (CRM) went down from 8.2% to 7.3%and 5.5% (pâ¯=â¯0.0004). Neoadjuvant treatment significantly decreased positive CRM in lower third tumors (OR 0.71, 0.59-0.87, Cochrane-Mantel-Haenszel Pâ¯=â¯0.0008). Most ypN0 patients also received adjuvant therapy. In MR-defined stage III patients, preoperative treatment was associated with significantly longer local-recurrence-free survival (pâ¯<â¯0.0001), and cancer-specific survival (pâ¯<â¯0.0001). The survival benefit was smaller in upper third cancers. CONCLUSION: There was an increasing trend and a potential overuse of neoadjuvant treatment in cancer of the upper rectum. Most ypN0 patients received postoperative treatment. Involvement of CRM in lower third tumors was reduced after neoadjuvant treatment. Stage III and MRcN + benefited the most.
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Previsões , Margens de Excisão , Estadiamento de Neoplasias , Neoplasias Retais/terapia , Sistema de Registros , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimiorradioterapia Adjuvante , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante , Neoplasias Retais/diagnóstico , Neoplasias Retais/epidemiologia , Estudos Retrospectivos , Espanha/epidemiologia , Taxa de Sobrevida/tendências , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections. METHODS: In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual. FINDINGS: Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ2 test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications. INTERPRETATION: The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery. FUNDING: Fundación Asociación Española de Coloproctología.
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Antibacterianos/uso terapêutico , Ciprofloxacina/uso terapêutico , Colo/cirurgia , Metronidazol/uso terapêutico , Cuidados Pré-Operatórios/normas , Infecção da Ferida Cirúrgica/prevenção & controle , Administração Intravenosa , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Ciprofloxacina/administração & dosagem , Colectomia/efeitos adversos , Colectomia/métodos , Colo/patologia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Humanos , Incidência , Masculino , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Método Simples-Cego , Espanha/epidemiologia , Infecção da Ferida Cirúrgica/epidemiologiaRESUMO
AIM: To identify short-term and oncologic outcomes of pelvic exenterations (PE) for locally advanced primary rectal cancer (LAPRC) in patients included in a national prospective database. METHODS: Few studies report on PE in patients with LAPRC. For this study, we included PE for LAPRC performed between 2006 and 2017, as available, from the Rectal Cancer Registry of the Spanish Association of Surgeons [Asociación Española de Cirujanos (AEC)]. Primary endpoints included procedure-associated complications, 5-year local recurrence (LR), disease-free survival (DFS) and overall survival (OS). A propensity-matched comparison with patients who underwent non-exenterative surgery for low rectal cancers was performed as a secondary endpoint. RESULTS: Eight-two patients were included. The mean age was 61.8 ± 11.5 years. More than half of the patients experienced at least one complication. Surgical site infections were the most common complication (abdominal wound 18.3%, perineal closure 19.4%). Thirty-three multivisceral resections were performed, including two hepatectomies and four metastasectomies. The long-term outcomes of the 64 patients operated on before 2013 were assessed. The five-year LR was 15.6%, the distant recurrence rate was 21.9%, and OS was 67.2%, with a mean survival of 43.8 mo. R+ve resection increased LR [hazard ratio (HR) = 5.58, 95%CI: 1.04-30.07, P = 0.04]. The quality of the mesorectum was associated with DFS. Perioperative complications were independent predictors of shorter survival (HR = 3.53, 95%CI: 1.12-10.94, P = 0.03). In the propensity-matched analysis, PE was associated with better quality of the specimen and tended to achieve lower LR with similar OS. CONCLUSION: PE is an extensive procedure, justified if disease-free margins can be obtained. Further studies should define indications, accreditation policy, and quality of life in LAPRC.
Assuntos
Recidiva Local de Neoplasia/prevenção & controle , Exenteração Pélvica/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Neoplasias Retais/cirurgia , Idoso , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Período Perioperatório , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Qualidade de Vida , Neoplasias Retais/mortalidade , Neoplasias Retais/patologia , Reto/patologia , Estudos Retrospectivos , Medição de Risco , Resultado do TratamentoRESUMO
This study aimed to improve gastric cancer (GC) diagnosis by identifying and validating an INflammatory PROtein-driven GAstric cancer Signature (hereafter INPROGAS) using low-cost affinity proteomics. The detection of 120 cytokines, 43 angiogenic factors, 41 growth factors, 40 inflammatory factors and 10 metalloproteinases was performed using commercially available human antibody microarray-based arrays. We identified 21 inflammation-related proteins (INPROGAS) with significant differences in expression between GC tissues and normal gastric mucosa in a discovery cohort of matched pairs (n=10) of tumor/normal gastric tissues. Ingenuity pathway analysis confirmed the "inflammatory response", "cellular movement" and "immune cell trafficking" as the most overrepresented biofunctions within INPROGAS. Using an expanded independent validation cohort (n = 22), INPROGAS classified gastric samples as "GC" or "non-GC" with a sensitivity of 82% (95% CI 59-94) and a specificity of 73% (95% CI 49-89). The positive predictive value and negative predictive value in this validation cohort were 75% (95% CI 53-90) and 80% (95% CI 56-94), respectively. The positive predictive value and negative predictive value in this validation cohort were 75% (95% CI 53-90) and 80% (95% CI 56-94), respectively. Antibody microarray analyses of the GC-associated inflammatory proteome identified a 21-protein INPROGAS that accurately discriminated GC from noncancerous gastric mucosa.
Assuntos
Indutores da Angiogênese/metabolismo , Biomarcadores Tumorais/metabolismo , Citocinas/metabolismo , Mucosa Gástrica/metabolismo , Metaloproteases/metabolismo , Neoplasias Gástricas/metabolismo , Movimento Celular , Reações Falso-Negativas , Reações Falso-Positivas , Feminino , Humanos , Imunidade Celular , Inflamação/metabolismo , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Análise Serial de Proteínas , Proteômica , Neoplasias Gástricas/diagnósticoRESUMO
BACKGROUND: The colonic pouch is considered as an alternative to the standard straight low anastomosis after resection for rectal cancer. The aim of this prospective randomized trial was to compare short- and long-term functional results of colonic J-pouch (CJP) and transverse coloplasty (TCP) after low anterior resection for rectal cancer. METHODS: Between 2000 and 2005, patients with mid or low rectal cancer scheduled for an elective sphincter-preserving resection were eligible. The primary end point was to compare bowel functional results 6 months and 3 years after ileostomy closure. Fecal incontinence score and a questionnaire that included items for clinical evaluation of bowel function were used. RESULTS: One-hundred six patients were randomized; 54 patients were allocated to the CJP group and 52 in the TCP group. There were no differences between the 2 groups in terms of demographic and clinical data. Overall, postoperative complication rate was 19.8% without differences between the groups. Two patients (1.9%; one in each group) presented with anastomotic dehiscence. Long-term incomplete evacuation rates were 29.2% in the CPT group and 33.3% in the CJP group, without substantial differences. Overall, short- and long-term functional outcomes of both procedures were comparable. No differences were observed in terms of fecal incontinence or in all the items included in the questionnaire. CONCLUSION: TCP reconstruction after rectal cancer resection and coloanal anastomosis is functionally similar to CJP both in short- and long-term outcomes. The TCP technique does not seem to improve significantly the incomplete defecation symptom respect to CJP. REGISTRATION NUMBER: NCT01396928; http://register.clinicaltrial.gov.
Assuntos
Procedimentos Cirúrgicos do Sistema Digestório/métodos , Neoplasias Retais/cirurgia , Idoso , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Incontinência Fecal/etiologia , Feminino , Humanos , Ileostomia/efeitos adversos , Ileostomia/métodos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Neoplasias Retais/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Derivative ileostomies are frequently performed to protect low anastomosis. The closure of the ileostomy has shown, under some circumstances, high associated mortality/morbidity rates. This study attempts to quantify the morbidity and mortality associated with ileostomy closure in rectal neoplasm patients and to determine if the length of time between the procedure of construction and closure increases the morbidity/mortality. MATERIAL AND METHOD: A retrospective study was performed, using the database of the colo-rectal surgical group in the department of general surgery. The subjects were the 62 patients treated between January 1, 2000 and December 31, 2006 who received both a low anterior resection to treat rectal neoplasm and a subsequent ileostomy closure. RESULTS: The mean patient age was 65 years (38-83) and consisted of 19 women (30.7%) and 43 men (69.3%). The mean time between the construction and closure was 10.48 months (2-56) and the mean hospital stay was 7.8 days (3-32). The overall morbidity/mortality rate was 33.8% and 6.4%. The most frequent surgical complications were postoperative intestinal occlusion (16.9%) and wound infection (11.2%). CONCLUSIONS: The study showed high morbidity/mortality rate for the closure of temporary ileostomy. Patients who received the closure more than 11.65 months after the low anterior resection had significantly higher morbidity/mortality rates.