Development of a warning score for early detection of colorectal anastomotic leakage: Hype or hope?

BACKGROUND: Colorectal anastomotic leakage (CAL), a severe postoperative complication, is associated with high morbidity, hospital readmission, and overall healthcare costs. Early detection of CAL remains a challenge in clinical practice. However, some decision models have been developed to increase the diagnostic accuracy of this event. AIM: To develop a score based on easily accessible variables to detect CAL early. METHODS: Based on the least absolute shrinkage and selection operator method, a predictive classification system was developed [Early ColoRectAL Leakage (E-CRALL) score] from a prospective observational, single center cohort, carried out in a colorectal division from a non-academic hospital. The score performance and CAL threshold from postoperative day (POD) 3 to POD5 were estimated. Based on a precise analytical decision model, the standard clinical practice was compared with the E-CRALL adoption on POD3, POD4, or POD5. A cost-minimization analysis was conducted, on the assumption that all alternatives delivered similar health-related effects. RESULTS: In this study, 396 patients who underwent colorectal resection surgery with anastomosis, and 6.3% (n = 25) developed CAL. Most of the patients who developed CAL (n = 23; 92%) were diagnosed during the first hospital admission, with a median time of diagnosis of 9.0 ± 6.8 d. From POD3 to POD5, the area under the receiver operating characteristic curve of the E-CRALL score was 0.82, 0.84, and 0.95, respectively. On POD5, if a threshold of 8.29 was chosen, 87.4% of anastomotic failures were identified with E-CRALL adoption. Additionally, score usage could anticipate CAL diagnosis in an average of 5.2 d and 4.1 d, if used on POD3 and POD5, respectively. Regardless of score adoption, episode comprehensive costs were markedly greater (up to four times) in patients who developed CAL in comparison with patients who did not develop CAL. Nonetheless, the use of the E-CRALL warning score was associated with cost savings of €421442.20, with most (92.9%) of the savings from patients who did not develop CAL. CONCLUSION: The E-CRALL score is an accessible tool to predict CAL at an early timepoint. Additionally, E-CRALL can reduce overall healthcare costs, mainly in the reduction of hospital costs, independent of whether a patient developed CAL.

Surviving rectal cancer at the cost of a colostomy: global survey of long-term health-related quality of life in 10 countries.

BACKGROUND: Colorectal cancer management may require an ostomy formation; however, a stoma may negatively impact health-related quality of life (HRQoL). This study aimed to compare generic and stoma-specific HRQoL in patients with a permanent colostomy after rectal cancer across different countries. METHOD: A cross-sectional cohorts of patients with a colostomy after rectal cancer in Denmark, Sweden, Spain, the Netherlands, China, Portugal, Australia, Lithuania, Egypt, and Israel were invited to complete questionnaires regarding demographic and socioeconomic factors along with the Colostomy Impact (CI) score, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and five anchor questions assessing colostomy impact on HRQoL. The background characteristics of the cohorts from each country were compared and generic HRQoL was measured with the EORTC QLQ-C30 presented for the total cohort. Results were compared with normative data of reference European populations. The predictors of reduced HRQoL were investigated by multivariable logistic regression, including demographic and socioeconomic factors and stoma-related problems. RESULTS: A total of 2557 patients were included. Response rates varied between 51-93 per cent. Mean time from stoma creation was 2.5-6.2 (range 1.1-39.2) years. A total of 25.8 per cent of patients reported that their colostomy impairs their HRQoL 'some'/'a lot'. This group had significantly unfavourable scores across all EORTC subscales compared with patients reporting 'no'/'a little' impaired HRQoL. Generic HRQoL differed significantly between countries, but resembled the HRQoL of reference populations. Multivariable logistic regression showed that stoma dysfunction, including high CI score (OR 3.32), financial burden from the stoma (OR 1.98), unemployment (OR 2.74), being single/widowed (OR 1.35) and young age (OR 1.01 per year) predicted reduced stoma-related HRQoL. CONCLUSION: Overall HRQoL is preserved in patients with a colostomy after rectal cancer, but a quarter of the patients interviewed reported impaired HRQoL. Differences among several countries were reported and socioeconomic factors correlated with reduced quality of life.

Usefulness of serum C-reactive protein and calprotectin for the early detection of colorectal anastomotic leakage: A prospective observational study.

BACKGROUND: Colorectal anastomotic leakage (CAL) is one of the most dreaded complications after colorectal surgery, with an incidence that can be as high as 27%. This event is associated with increased morbidity and mortality; therefore, its early diagnosis is crucial to reduce clinical consequences and costs. Some biomarkers have been suggested as laboratory tools for the diagnosis of CAL. AIM: To assess the usefulness of plasma C-reactive protein (CRP) and calprotectin (CLP) as early predictors of CAL. METHODS: A prospective monocentric observational study was conducted including patients who underwent colorectal resection with anastomosis, from March 2017 to August 2019. Patients were divided into three groups: G1 - no complications; G2 - complications not related to CAL; and G3 - CAL. Five biomarkers were measured and analyzed in the first 5 postoperative days (PODs), namely white blood cell (WBC) count, eosinophil cell count (ECC), CRP, CLP, and procalcitonin (PCT). Clinical criteria, such as abdominal pain and clinical condition, were also assessed. The correlation between biomarkers and CAL was evaluated. Receiver operating characteristic (ROC) curve analysis was used to compare the accuracy of these biomarkers as predictors of CAL, and the area under the ROC curve (AUROC), specificity, sensitivity, positive predictive value, and negative predictive value (NPV) during this period were estimated. RESULTS: In total, 25 of 396 patients developed CAL (6.3%), and the mean time for this diagnosis was 9.0 ± 6.8 d. Some operative characteristics, such as surgical approach, blood loss, intraoperative complications, and duration of the procedure, were notably related to the development of CAL. The length of hospital stay was markedly higher in the group that developed CAL compared with the group with complications other than CAL and the group with no complications (median of 21 d vs 13 d and 7 d respectively; P < 0.001). For abdominal pain, the best predictive performance was on POD4 and POD5, with the largest AUROC of 0.84 on POD4. Worsening of the clinical condition was associated with the diagnosis of CAL, presenting a higher predictive effect on POD5, with an AUROC of 0.9. WBC and ECC showed better predictive effects on POD5 (AUROC = 0.62 and 0.7, respectively). Those markers also presented a high NPV (94%-98%). PCT had the best predictive effect on POD5 (AUROC = 0.61), although it presented low accuracy. However, this biomarker revealed a high NPV on POD3, POD4, and POD5 (96%, 95%, and 96%, respectively). The mean CRP value on POD5 was significantly higher in the group that developed CAL compared with the group without complications (195.5 ± 139.9 mg/L vs 59.5 ± 43.4 mg/L; P < 0.00001). On POD5, CRP had a NPV of 98%. The mean CLP value on POD3 was significantly higher in G3 compared with G1 (5.26 ± 3.58 µg/mL vs 11.52 ± 6.81 µg/mL; P < 0.00005). On POD3, the combination of CLP and CRP values showed a high diagnostic accuracy (AUROC = 0.82), providing a 5.2 d reduction in the time to CAL diagnosis. CONCLUSION: CRP and CLP are moderate predictors of CAL. However, the combination of these biomarkers presents an increased diagnostic accuracy, potentially decreasing the time to CAL diagnosis.

Life with a stoma across five European countries-a cross-sectional study on long-term rectal cancer survivors.

PURPOSE: Stoma-related problems are known to be important to patients and potentially affect everyday life. The prevalence of stoma-related problems in rectal cancer survivors remains undetermined. This study aimed to examine aspects of life with a long-term stoma, stoma management, and stoma-related problems and explore the impact of stoma-related problems on daily life. METHODS: In total, 2262 patients from 5 European countries completed a multidimensional survey. Stoma-related problems were assessed using the Colostomy Impact score. Multivariable regression analysis, after adjusting for potential confounding factors, provided odds ratio (OR) and 95% confidence intervals (CI) for stoma-related problems' association with restrictions in daily life. RESULTS: The 2262 rectal cancer survivors completed the questionnaire at a median of 5.4 years (interquartile range 3.8-7.6) after stoma formation. In the total sample, leakage (58%) and troublesome odour (55%) were most prevalent followed by skin problems (27%) and pain (21%). Stoma-related problems were more prevalent in patients with parastomal bulging. A total of 431 (19%) reported feeling restricted in daily activities in life with a stoma. Leakage, odour, skin problems, stool consistency, and frequent appliance changes were significantly associated with restrictions in daily life. The highest risk of experiencing restrictions was seen for patients having odour (OR 2.74 [95% CI: 1.99-3.78]) more than once a week and skin problems (OR 1.77 [95% CI: 1.38-2.27]). CONCLUSION: In this large cohort with rectal cancer, stoma-related problems were highly prevalent and impacted daily life. Supportive care strategies should entail outreach to patients with a long-term stoma.

Translation and international validation of the Colostomy Impact score.

AIM: Optimal oncological resection in cancers of the lower rectum often requires a permanent colostomy. However, in some patients a colostomy may have a negative impact on health-related quality of life (HRQoL). The Colostomy Impact (CI) score is a simple questionnaire that identifies patients with stoma dysfunction that impairs HRQoL by dividing patients into 'minor' and 'major' CI groups. This aim of this study is to evaluate construct and discriminative validity, sensitivity, specificity and reliability of the CI score internationally, making it applicable for screening and identification of patients with stoma-related impaired HRQoL. METHOD: The CI score was translated in agreement with WHO recommendations. Cross-sectional cohorts of rectal cancer survivors with a colostomy in Australia, China, Denmark, the Netherlands, Portugal, Spain and Sweden were asked to complete the CI score, the European Organization for Research and Treatment of Cancer (EORTC) quality of life 30-item core questionnaire, the stoma-specific items of the EORTC quality of life 29-item colorectal-specific questionnaire and five anchor questions assessing the impact of colostomy on HRQoL. RESULTS: A total of 2470 patients participated (response rate 51%-93%). CI scores were significantly higher in patients reporting reduced HRQoL due to their colostomy than in patients reporting no reduction. Differences in EORTC scale scores between patients with minor and major CI were significant and clinically relevant. Sensitivity was high regarding dissatisfaction with a colostomy. Regarding evaluation of discriminative validity, the CI score relevantly identified groups with differences in HRQoL. The CI score proved reliable, with equal CI scores between test and retest and an intraclass correlation coefficient in the moderate to excellent range. CONCLUSION: The CI score is internationally valid and reliable. We encourage its use in clinical practice to identify patients with stoma dysfunction who require further attention.

Validation of Portuguese version of the low anterior resection syndrome score / Validação da versão em português do escore da síndrome da ressecção anterior baixa

ABSTRACT Objective: The authors aim to perform a thorough translation with cultural adaptation of the patient reported outcome tool, Low Anterior Resection Syndrome (LARS) Score, to the Portuguese language (LARS-PT) in the Portuguese population with rectal cancer, after proctectomy with anastomosis. Methods: According to the current international recommendations, we designed this study encompassing three main phases: (i) cultural and linguistic validation to European Portuguese; (ii) feasibility and reliability tests of the version obtained in the previous phase; and (iii) validity tests to produce a final version. The questionnaire was completed by 154 patients from six Portuguese Colorectal Cancer Units, and 58 completed it twice. Results: Portuguese version of LARS score showed high construct validity. Regarding the test-retest, the global Intraclass Correlation showed very strong test-retest reliability. Looking at all five items, only items 3 and 5 present a moderate correlation. LARS score was able to discriminate symptoms showing worse quality of life, in patients submitted to preoperative radio and chemotherapy. Conclusions: LARS questionnaire has been properly translated into European Portuguese, demonstrating high construct validity and reliability. This is a precise, reproducible, simple, clear and user-friendly tool for evaluating bowel function in rectal cancer patients after sphincter saving operation.

RESUMO Objetivo: Os autores pretendem fazer uma tradução minuciosa e culturalmente adaptada para a língua portuguesa do escore da Síndrome de Ressecção Anterior Baixa (Low Anterior Resection Syndrome [LARS]), um instrumento de desfecho relatado pelo paciente, na população portuguesa com câncer retal após proctectomia com anastomose. Métodos: De acordo com as recomendações internacionais atuais, o estudo foi projetado abrangendo três fases principais: (i) validação cultural e linguística para o português europeu; (ii) testes de viabilidade e confiabilidade da versão obtida na fase anterior; e (iii) testes de validade para produzir a versão final. O questionário foi preenchido por 154 pacientes de seis unidades portuguesas de câncer colorretal e 58 pacientes completaram duas vezes. Resultados: A versão em português do escore LARS mostrou alta validade de construto. A correlação intra-classe global apresentou confiabilidade muito forte no teste-reteste. Considerando-se todos os cinco itens, apenas os itens 3 e 5 apresentam uma correlação moderada. O escore LARS foi capaz de discriminar sintomas com pior qualidade de vida em pacientes submetidos a radio- e quimioterapia pré-operatória. Conclusões: O questionário LARS foi traduzido corretamente para o português europeu, demonstrando alta validade de construto e confiabilidade. Trata-se de uma ferramenta precisa, reproduzível, simples, clara e fácil de usar para avaliar a função intestinal em pacientes com câncer retal após operações poupando o esfíncter.

Lung metastases from colorectal cancer: surgical resection and prognostic factors.

OBJECTIVE: To analyse our experience with excision of lung metastases from colorectal carcinoma (CRC), and to evaluate clinically relevant prognostic factors, identifying the cluster of patients who would benefit from this procedure. METHODS: Sixty-one patients, 42 men (69%), with primary CRC who underwent 94 curative resections of pulmonary metastases were retrospectively reviewed. Age was 30-80 years (mean 61.2+/-15). Population was analysed for age, sex, disease-free interval (DFI), prethoracotomy carcinoembryonic antigen (CEA) level, location and histology of primary tumour, number of lung lesions (and size of largest resected metastasis), type of lung resection, nodal involvement (hilar/mediastinal), use of adjuvant treatment, morbid-mortality and immediate and follow-up survival. RESULTS: Mean DFI was 29+/-22 months (range 5-132 months). There was no hospital mortality and significant morbidity occurred in five patients (8.2%). Mean follow-up was 39+/-4 months (range 4-173 months). Mean overall survival and disease-free survival were 67+/-16 months and 52+/-6 months, respectively. Three-, 5- and 10-year survival rates from date of primary colorectal resection were 83%, 71% and 43%, respectively. Three-, 5- and 10-year survival rates from date of lung resection were 61%, 48% and 11%, respectively. Five-year survival was 57% in patients with normal prethoracotomy CEA levels and 18% for those with high levels (>5 ng/ml) (p=0.039). CONCLUSIONS: Pulmonary metastasectomy has potential survival benefit for patients with metastatic colorectal carcinoma. Low morbidity and mortality rates, contrasting with lack of any other effective therapy, justify aggressive surgical management. Single deposits, DFI >36 months and normal prethoracotomy serum CEA were significant independent prognostic factors.