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Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis.

ABSTRACT: BACKGROUND:The purpose of this study was to test use of the Dutch leakage score (DLS), serum C-reactive protein (CRP) and serum procalcitonin (PCT) in the diagnosis of anastomotic leakage (AL) after elective colorectal resection in a prospective observational study. METHODS:Patients undergoing elective colorectal resection with anastomosis in 19 centres were enrolled over a 1-year period from September 2017. The DLS and CRP and PCT levels were evaluated on postoperative day (POD) 2, POD3 and POD6. Statistical analysis, including determination of the area under the receiver operating characteristic (ROC) curve (AUC), was performed for the primary endpoint of AL; secondary endpoints were morbidity and mortality rates ( ClinicalTrials.gov identifier: NCT03560180). RESULTS:Among 1546 patients enrolled, the AL rate was 4·9 per cent. Morbidity and mortality rates were 30·2 and 1·3 per cent respectively. With respect to AL, DLS performed better than CRP and PTC levels on POD2 and POD3 (AUC 0·75 and 0·84), whereas CRP levels were documented with better AUC values on POD6 (AUC 0·81). Morbidity was poorly predicted, whereas mortality was best predicted by PCT on POD2 (AUC 0·83) and by DLS on POD3 and POD6 (AUC 0·87 and 0·98 respectively). Overall, the combination of positive PCT, CRP and DLS values resulted in a probability of AL of 21·3 per cent on POD2, 33·4 per cent on POD3, and 47·1 per cent on POD6. However, the combination of their negative values excluded AL in 99·0 per cent of cases on POD2, 99·3 per cent on POD3, and 99·2 per cent on POD6. CONCLUSION:DLS and CRP level are good positive and excellent negative predictors of AL; the addition of PCT improved the predictive value for diagnosis of AL.

SUBMITTER: Italian ColoRectal Anastomotic Leakage (iCral) Study Group

PROVIDER: S-EPMC7260403 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis.

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<h4>Background</h4>The purpose of this study was to test use of the Dutch leakage score (DLS), serum C-reactive protein (CRP) and serum procalcitonin (PCT) in the diagnosis of anastomotic leakage (AL) after elective colorectal resection in a prospective observational study.<h4>Methods</h4>Patients undergoing elective colorectal resection with anastomosis in 19 centres were enrolled over a 1-year period from September 2017. The DLS and CRP and PCT levels were evaluated on postoperative day (POD) ...[more]

PMID: 32134216

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Project description:BackgroundAnastomotic leakage (AL) has always been one of the most serious complications of esophagectomy with gastric conduit reconstruction. There are many strong risk factors for AL in clinical practice. Notably, the tension at the esophagogastric anastomosis and the blood supply to the gastric conduit directly affect the integrity of the anastomosis. However, there has been a lack of quantitative research on the tension and blood supply of the gastric conduit. Changes in extracellular matrix collagen reflect tension and blood supply, which affect the quality of the anastomosis. This study aimed to establish a quantitative collagen score to describe changes in the collagen structure in the extracellular matrix and to identify patients at high risk of postoperative AL.MethodsA retrospective study of 213 patients was conducted. Clinical and pathological data were collected at baseline. Optical imaging of the "donut" specimen at the anastomotic gastric end and collagen feature extraction were performed. Least absolute shrinkage and selection operator (LASSO) regression models were used to select the significant collagen features, compute collagen scores, and validate the predictive efficacy of the collagen scores for ALs.ResultsLASSO regression analysis revealed three collagen-related parameters in the gastric donuts: histogram mean, histogram variance, and histogram energy. Based on this analysis, we established a formula to calculate the collagen score. The results of the univariate analysis revealed significant differences in the preoperative low albumin values (P=0.002) and collagen scores between the AL and non-AL groups (P=0.001), while the results of the multivariate analysis revealed significant differences in the collagen scores between the AL and non-AL groups (P=0.002). The areas under the curve (AUCs) of the experimental and validation cohorts were 0.978 [95% confidence interval (CI): 0.931-0.996] and 0.900 (95% CI: 0.824-0.951), respectively.ConclusionsThe collagen score established herein was shown to be related to AL and can be used to predict AL in patients who underwent esophagectomy.

Project description:BackgroundAnastomotic leakage (AL) is a severe complication after colorectal surgery. This study aimed to investigate a method for the early diagnosis of AL after surgical resection by analysing inflammatory factors (IFs) in peritoneal drainage fluid.MethodsAbdominal drainage fluid of patients with colorectal cancer who underwent resection between April 2017 and April 2018, were prospectively collected in the postoperative interval. Six IFs, including interleukin (IL)-1β, IL-6, IL-10, tumour necrosis factor (TNF)-α, matrix metalloproteinase (MMP)2, and MMP9, in drainage were determined by multiplex immunoassay to investigate AL (in patients undergoing resection and anastomosis) and pelvic collection (in patients undergoing abdominoperineal resection). Sparreboom and colleagues' prediction model was first evaluated for AL/pelvic collection, followed by a new IF-based score system (AScore) that was developed by a least absolute shrinkage and selection operator (LASSO) regression, for the same outcomes. The model performance was tested for the area under the curve (AUC), sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV).ResultsOut of 123 patients eligible, 119 patients were selected, including 12 patients with AL/pelvic collection. Sparreboom and colleagues' prediction model was documented with the best diagnostic efficacy on postoperative day 3 (POD3), with an AUC of 0.77. After optimization, AScore on POD3 increased the AUC to 0.83 and on POD1 showed the best diagnostic efficiency, with an AUC of 0.88. Based on the Youden index, the cut-off value of AScore on POD1 was set as -2.46 to stratify patients into low-risk and high-risk groups for AL/pelvic collection. The model showed 90.0 per cent sensitivity, 69.7 per cent specificity, 98.4 per cent NPV, and 25.0 per cent PPV.ConclusionsThe early determination of IFs in abdominal drainage fluid of patients undergoing colorectal surgery could be useful to predict AL or pelvic collection.

Project description:OBJECTIVE:Near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) might help reduce anastomotic leakage (AL) after colorectal surgery. This pilot study aims to analyze whether a relation exists between measured fluorescence intensity (FI) and postoperative inflammatory markers of AL, C-reactive protein (CRP), Intestinal fatty-acid binding protein (I-FABP), and calprotectin, to AL, in order to evaluate the potential of FI to objectively predict AL. METHODS:Patients scheduled for anastomotic colorectal cancer surgery were eligible for inclusion in this prospective pilot study. During surgery, at three time points (after bowel devascularization; before actual transection; after completion of anastomosis) a bolus of 0.2 mg/kg ICG was administered intravenously for assessment of bowel perfusion. FI was scored in scale from 1 to 5 based on the operating surgeon's judgment (1?=?no fluorescence visible, 5?=?maximum fluorescent signal). The complete surgical procedure was digitally recorded. These recordings were used to measure FI postoperatively using OsiriX imaging software. Serum CRP, I-FABP, and calprotectin values were determined before surgery and on day 1, 3, and 5 postoperative; furthermore, the occurrence of AL was recorded. RESULTS:Thirty patients (n?=?19 males; mean age 67 years; mean BMI 27.2) undergoing either laparoscopic or robotic anastomotic colorectal surgery were included. Indication for surgery was rectal-(n?=?10), rectosigmoid-(n?=?2), sigmoid-(n?=?10), or more proximal colon carcinomas (n?=?8). Five patients (16.7%) developed AL (n?=?2 (6.6%) grade C according to the definition of the International Study group of Rectal Cancer). In patients with AL, the maximum fluorescence score was given less often (P?=?0.02) and a lower FI compared to background FI was measured at 1st assessment (P?=?0.039). However, no relation between FI and postoperative inflammatory parameters could be found. CONCLUSION:Both subjective and measured FI seem to be related to AL. In this study, no relation between FI and inflammatory serum markers could yet be found.

Project description:BACKGROUND:Anastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor. OBJECTIVE:This prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL. METHODS:This study aims to include 588 patients undergoing surgery for colorectal carcinoma. Patients will be eligible for inclusion when surgery includes the construction of a colorectal anastomosis. Patient characteristics will be collected upon consented inclusion, and buccal swabs, breath, stool, and blood samples will be obtained prior to surgery. These samples will allow for the collection of information regarding patients' inflammatory status, genetic predisposition, and intestinal microbiota. Additionally, breath and blood samples will be taken postoperatively and patients will be strictly observed during their in-hospital stay, and the period shortly thereafter. RESULTS:This study has been open for inclusion since August 2015. CONCLUSIONS:An estimated 8-10% of patients will develop AL following surgery, and they will be compared to non-leakage patients. The objectives of this study are twofold. The primary aim is to establish and validate a diagnostic algorithm for the pre-operative prediction of the risk of AL development using a combination of inflammatory, immune-related, and genetic parameters. Previously established risk factors and novel parameters will be incorporated into this algorithm, which will aid in the recognition of patients who are at risk for AL. Based on these results, recommendations can be made regarding the construction of an anastomosis or deviating stoma, and possible preventive strategies. Furthermore, we aim to develop a new algorithm for the post-operative diagnosis of AL at an earlier stage, which will positively reflect on short-term survival rates. TRIAL REGISTRATION:Clinicaltrials.gov: NCT02347735; https://clinicaltrials.gov/ct2/show/NCT02347735 (archived by WebCite at http://www.webcitation.org/6hm6rxCsA).

Dataset Information

Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis.

Publications

Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis.

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