Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 28, 2022; 28(24): 2758-2774
Published online Jun 28, 2022. doi: 10.3748/wjg.v28.i24.2758
Usefulness of serum C-reactive protein and calprotectin for the early detection of colorectal anastomotic leakage: A prospective observational study
Nuno J G Rama, Marlene C C Lages, Maria Pedro S Guarino, Óscar Lourenço, Patrícia C Motta Lima, Diana Parente, Cândida S G Silva, Ricardo Castro, Ana Bento, Anabela Rocha, Fernando Castro-Pocas, João Pimentel
Nuno J G Rama, Patrícia C Motta Lima, Diana Parente, Colorectal Surgical Division, Leiria Hospital Centre, Leiria 2410-021, Portugal
Nuno J G Rama, Anabela Rocha, Fernando Castro-Pocas, Abel Salazar Biomedical Institute (ICBAS), University of Oporto, Oporto 4099-002, Portugal
Nuno J G Rama, Marlene C C Lages, Maria Pedro S Guarino, Cândida S G Silva, Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria, Leiria 2410-541, Portugal
Óscar Lourenço, Faculty of Economics, CeBER, University of Coimbra, Coimbra 3000-137, Portugal
Ricardo Castro, Ana Bento, Clinical Pathology Division, Leiria Hospital Centre, Leiria 2410-541, Portugal
Anabela Rocha, Surgical Division, Oporto Hospital Centre, Oporto 4099-001, Portugal
Fernando Castro-Pocas, Department of Gastroenterology, Santo António Hospital, Porto Hospital Center, Porto 4099-001, Portugal
Fernando Castro-Pocas, Institute of Biomedical Sciences Abel Salazar, University of Porto, Porto 4099-001, Portugal
João Pimentel, Faculty of Medicine, University of Coimbra, Coimbra 3004-531, Portugal
João Pimentel, Surgical Division, Montes Claros Hospital, Coimbra 3030-320, Portugal
Author contributions: Rama NJM, Guarino MPS, and Lourenço Ó designed the study; Lages MCC, Castro R, Bento A, and Parente D coordinated the data collection process; Lourenço Ó and Silva CSG performed the data analyses; Rama NJM, Motta Lima PC and Guarino MPS prepared the manuscript; Rama NJM, Rocha A, Castro-Poças F, and Pimentel J revised the paper critically; All authors read and approved the final manuscript.
Supported by the Ministry of Health – Incentive Program for the Integration of Care and Valuation of Patients’ Pathways in the National Health Service of Portugal.
Institutional review board statement: This study was conducted in accordance with the Declaration of Helsinki and was approved by the Local Ethical Committee of the Colorectal Referral Centre, after authorization obtained from the Portuguese Data Protection Authority. This study is registered with the number 9930/2016 and can be consulted at https://drive.google.com/file/d/1BiLxWlvcrqpX4KQrjW4F2codsOOywVF/view?usp=sharing.
Informed consent statement: Informed consent was obtained from all participants included in the study.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
Data sharing statement: For additional data, Dr. Nuno Rama can be contacted by e-mail at ramanuno@gmail.com.
STROBE statement: The authors have read the STROBE Statement – checklist of items, and the manuscript was prepared and revised according to the STROBE Statement – checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Nuno JG Rama, FEBS, MD, MHSc, Associate Professor, Research Assistant Professor, Surgeon, Colorectal Surgical Division, Leiria Hospital Centre, Rua das Olhalvas, Leiria 2410-021, Portugal. ramanuno@gmail.com
Received: January 13, 2022
Peer-review started: January 13, 2022
First decision: March 8, 2022
Revised: March 22, 2022
Accepted: May 14, 2022
Article in press: May 14, 2022
Published online: June 28, 2022
Processing time: 161 Days and 13.8 Hours
Abstract
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.

Keywords: Anastomotic leakage; Colorectal; Surgery; Biomarkers; C-reactive protein; Calprotectin

Core Tip: Colorectal anastomotic leakage (CAL) remains a serious postoperative complication. It is associated with high morbidity rates, affecting overall costs and patients’ quality of life. Clinical criteria, imaging studies, and biomarkers have been considered to increase diagnostic accuracy. Plasma C-reactive protein, calprotectin, procalcitonin, white blood cell count, and eosinophil cell count have been proposed as predictors of anastomotic leakage. The combination of C-reactive protein and calprotectin after a minimal clinical suspicion of CAL has shown good diagnostic accuracy, allowing clinicians to reduce the time to CAL detection. Regression models can facilitate building a decision model, as the score proposed for the early detection of CAL.