Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Nov 27, 2022; 14(11): 1297-1309
Published online Nov 27, 2022. doi: 10.4240/wjgs.v14.i11.1297
Development of a warning score for early detection of colorectal anastomotic leakage: Hype or hope?
Nuno J G Rama, Óscar Lourenço, Patrícia C Motta Lima, Maria Pedro S Guarino, Diana Parente, Ricardo Castro, Ana Bento, Anabela Rocha, Fernando Castro-Poças, João Pimentel
Nuno J G Rama, Patrícia C Motta Lima, Diana Parente, Division of Colorectal Surgical, Leiria Hospital Centre, Leiria 2410-021, Portugal
Nuno J G Rama, Anabela Rocha, Abel Salazar Biomedical Institute, University of Oporto, Oporto 4099-002, Portugal
Nuno J G Rama, Maria Pedro S Guarino, 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, Division of Clinical Pathology, Leiria Hospital Centre, Leiria 2410-541, Portugal
Anabela Rocha, Division of Surgical, Oporto Hospital Centre, Oporto 4099-001, Portugal
Fernando Castro-Poças, Department of Gastroenterology, Santo António Hospital, Porto Hospital Center, Oporto 4099-001, Portugal
Fernando Castro-Poças, Institute of Biomedical Sciences Abel Salazar, University of OPorto, Oporto 4099-001, Portugal
João Pimentel, Faculty of Medicine, University of Coimbra, Coimbra 3004-531, Portugal
João Pimentel, Division of Surgical, Montes Claros Hospital, Coimbra 3030-320, Portugal
Author contributions: Rama NJM, Guarino MPS, and Lourenço Ó designed the study; Lourenço Ó performed the data analyses; Rama NJM, Motta Lima PC and Guarino MPS prepared the manuscript; Rama NJM, Rocha A, Castro-Poças F, andPimentel 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.
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 J G Rama, FEBS, MD, MHSc, Associate Professor, Research Assistant Professor, Surgeon, Division of Colorectal Surgical, Leiria Hospital Centre, Rua das Olhalvas, Leiria 2410-021, Portugal. ramanuno@gmail.com
Received: September 12, 2022
Peer-review started: September 12, 2022
First decision: October 3, 2022
Revised: September 22, 2022
Accepted: October 27, 2022
Article in press: October 27, 2022
Published online: November 27, 2022
Processing time: 73 Days and 10.6 Hours
Abstract
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.

Keywords: Anastomotic leakage; Colorectal; Surgery; Biomarkers; Score; Costs

Core Tip: Colorectal anastomotic leakage, a severe postoperative complication, is associated with high morbidity, hospital readmission, and overall healthcare costs. Early detection of colorectal anastomotic leakage remains a challenge in clinical practice. Some decision models have been developed to increase the diagnostic accuracy of this event. A score designed with easily accessible variables could have a positive impact on timely diagnosis of colorectal anastomotic leakage and could minimize healthcare costs.