Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.

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.

Resultados quirúrgicos estándar tras resección oncológica de colon. Creación de un nomograma para la autoevaluación / Standard outcome indicators after colon cancer resection. Creation of a nomogram for autoevaluation

INTRODUCCIÓN: Existe un gran interés en los últimos años en identificar estándares de calidad en las distintas enfermedades, entre ellas, el cáncer de colon debido a su alta prevalencia. El objetivo del presente estudio es definir unos valores estándar de calidad en los resultados de la cirugía del cáncer de colon. MÉTODOS: Se han utilizado los datos del estudio prospectivo multicéntrico nacional «ANACO», que incluye pacientes con cáncer de colon intervenidos en 52 hospitales españoles (2011-2012). Para el presente análisis se han excluido los centros con menos de 30 pacientes y han quedado finalmente 42 hospitales (2.975 pacientes). Se presentan los valores de 4indicadores de calidad principales a partir de los cuales se ha creado un nomograma que permite definir unos resultados estándar de la cirugía del cáncer de colon. Además se proporcionan los resultados estándares de otros 10 indicadores de calidad secundarios (5 intraoperatorios y 5 postoperatorios). RESULTADOS: La mediana de fuga anastomótica y de mortalidad de los 42 hospitales fue de 8,5% (percentiles 25-75: 6,1-12,4%) y de 2,5% (percentiles 25-75: 0,6-4,7%), respectivamente. La mediana de ganglios aislados fue de 15,1 (percentiles 25-75: 18-14 ganglios). La mediana de estancia hospitalaria postoperatoria fue de 7,7 días (percentiles 25-75: 6,9-9,2 días). Basándonos en estos resultados se ha construido un nomograma para la autoevaluación de los distintos hospitales. CONCLUSIONES: El presente análisis ha permitido definir unos resultados quirúrgicos estándar tras la resección del cáncer de colon y se ha creado un instrumento de autoevaluación para las distintas unidades, de tal forma que cada centro puede identificar posibles áreas de mejora en el tratamiento de esta enfermedad

INTRODUCTION: Lately there has been an increasing interest in identifying quality standards in different pathologies, among them colon cancer due to its great prevalence. The main goal of this study is to define the quality standards of colon cancer surgery based on a large prospective national study dataset. METHODS: Data from the prospective national study ANACO were used. This study included a consecutive series of patients operated on for colon cancer in 52 Spanish hospitals (2011-2012). Centers with less than 30 patients were excluded. The present analysis finally included 42 centers (2975 patients). Based on the results obtained in 4main indicators from each hospital (anastomotic leak, lymph-nodes found in the specimen, mortality and length of stay), a nomogram that allows the evaluation of the performance of each center was designed. Standard results for further 5 intraoperative and 5 postoperative quality indicators were also reported. RESULTS: Median of anastomotic leak and mortality rate was 8.5% (25th-75th percentiles 6.1%-12.4%) and 2.5% (25th-75th percentiles 0.6%-4.7%), respectively. Median number of nodes found in the surgical specimen was 15,1 (25th-75th percentiles 18-14 nodes). Median length of postoperative stay was 7.7 days (25th-75th percentiles 6.9-9.2 days). Based on these data, a nomogram for hospital audit was created. CONCLUSIONS: Standard surgical results after colon cancer surgery were defined, creating a tool for auto-evaluation and allowing each center to identify areas for improvement in the surgical treatment of colon cancer

Standard outcome indicators after colon cancer resection. Creation of a nomogram for autoevaluation. / Resultados quirúrgicos estándar tras resección oncológica de colon. Creación de un nomograma para la autoevaluación.

INTRODUCTION: Lately there has been an increasing interest in identifying quality standards in different pathologies, among them colon cancer due to its great prevalence. The main goal of this study is to define the quality standards of colon cancer surgery based on a large prospective national study dataset. METHODS: Data from the prospective national study ANACO were used. This study included a consecutive series of patients operated on for colon cancer in 52 Spanish hospitals (2011-2012). Centers with less than 30 patients were excluded. The present analysis finally included 42 centers (2975 patients). Based on the results obtained in 4main indicators from each hospital (anastomotic leak, lymph-nodes found in the specimen, mortality and length of stay), a nomogram that allows the evaluation of the performance of each center was designed. Standard results for further 5 intraoperative and 5 postoperative quality indicators were also reported. RESULTS: Median of anastomotic leak and mortality rate was 8.5% (25th-75th percentiles 6.1%-12.4%) and 2.5% (25th-75th percentiles 0.6%-4.7%), respectively. Median number of nodes found in the surgical specimen was 15,1 (25th-75th percentiles 18-14 nodes). Median length of postoperative stay was 7.7 days (25th-75th percentiles 6.9-9.2 days). Based on these data, a nomogram for hospital audit was created. CONCLUSIONS: Standard surgical results after colon cancer surgery were defined, creating a tool for auto-evaluation and allowing each center to identify areas for improvement in the surgical treatment of colon cancer.