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
Research background

Colorectal anastomotic leakage (CAL) is a surgical complication with a huge impact on morbidity and mortality. Early diagnosis of CAL can reduce these complications as well as hospital readmission and overall healthcare costs.

Research motivation

Decision models have been developed to increase the diagnostic accuracy of CAL. A user-friendly score applied in routine clinical practice can have a positive impact on the timely diagnosis of CAL and minimize healthcare costs.

Research objectives

To develop a score capable of assisting clinicians in early and accurate detection of CAL. In addition, we aimed to assess the cost-effectiveness of using this classification system in daily clinical practice.

Research methods

From March 1, 2017 to August 31, 2019, 396 patients who underwent colorectal resection with anastomosis were enrolled in a prospective, observational, single center study. A score based on the least absolute shrinkage and selection operator method developed and named the Early ColoRectAL Leakage (E-CRALL) score. The score performance and CAL threshold from postoperative day (POD) 3 to POD5 were estimated. A cost-minimization analysis was also conducted.

Research results

This study included 396 patients who underwent colorectal resection with anastomosis. Among them, 6.3% (n = 25) developed CAL. The median time to CAL diagnosis was 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. The score anticipated CAL diagnosis in an average of 5.2 d and 4.1 d if used on POD3 and POD5, respectively. Overall costs in patients who developed CAL were markedly higher in comparison with patients who did not develop CAL. The E-CRALL warning score was associated with a cost savings of €421442.20.

Research conclusions

The E-CRALL score demonstrated a high predictive ability, with sensitivity and a negative predictive value of 100% on POD4 and a significant specificity (86.6%) on POD5. The routine adoption of the E-CRALL score may help prioritize CAL detection. Overall costs decreased after E-CRALL use, revealing a noteworthy reduction of in-hospital costs, independent of CAL status, which was primarily from the reduction in the LOHS for patients who did not develop CAL.

Research perspectives

A prospective, multicentric study will be conducted to test the warning score and promote external validation of our research.