Development and external validation of preoperative risk models for operative morbidities after total gastrectomy using a Japanese web-based nationwide registry

Abstract

Background: Total gastrectomy is a relatively difficult and invasive procedure among gastrointestinal surgeries, and major morbidities following total gastrectomy can be serious and fatal. This study aimed to develop and validate preoperative risk models of morbidities associated with total gastrectomy using a Japanese web-based nationwide registry.

Methods: The national clinical database was used to retrieve the records of 39,253 patients who underwent total gastrectomy in 1,841 hospitals between January 1, 2011 and December 31, 2012.

Results: Mean patient age was 69.1 years, and 73.8% of the patients were male. The overall morbidity rate was 21.5%, which included 8.1% with surgical site infection (SSI), 4.5% with anastomotic leak, 5.0% with pancreatic fistula, 3.7% with pneumonia, 1.9% with prolonged ventilation, and 1.2% with renal failure. Sex, splenectomy, and Brinkman index were selected as common risk factors for SSI, anastomotic leak, and pancreatic fistula. Pancreatectomy was the most significant preoperative risk factor in the risk model of SSI and pancreatic fistula. Need of assistance with activities of daily living, chronic obstructive pulmonary disease, previous cerebrovascular disease, American Society of Anesthesiologists score class 3 and over, presence of esophageal cancer, and body mass index more than 25 were selected as common risk factors for pneumonia, prolonged ventilation over 48 h, and renal failure.

Conclusions: We have created the first reported risk models of morbidities associated with total gastrectomy, using a Japanese nationwide database. The risk models developed in this study may be useful to preoperatively predict operative morbidities in patients undergoing total gastrectomy.

Keywords: Morbidity; Mortality; National Clinical Database; Risk model; Total gastrectomy.

Conflict of interest statement

Animal studies

This article does not contain any studies with human or animal subjects performed by any of the authors.

Conflict of interest

None of the authors had any potential conflicts of interest, including relevant financial interests, activities, relationships, and affiliations. This study was partially supported by a research grant from the Japanese Ministry of Health, Labour and Welfare.

Human rights statement and informed consent

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent or a substitute for it was obtained from all patients for being included in the study.

Figures

Fig. 1

Receiver operating characteristic (ROC) curves of surgical complications (upper panels) and nonsurgical complications (lower panels) in the validation dataset consisting of 20% of the National Clinical Database (NCD) total gastrectomy population registered in 2011 and 2012. The C-index, a measure of model discrimination represented by the area under the ROC curve, was 0.635 for surgical site infection (95% CI, 0.613–0.657; p < 0.001), 0.614 for anastomotic leak (95% CI, 0.585–0.643; p < 0.001), 0.657 for pancreatic fistula (95% CI, 0.628–0.686; p < 0.001), 0.726 for pneumonia (95% CI, 0.697–0.755; p < 0.001), 0.758 for prolonged ventilation over 48 h (95% CI, 0.717–0.799; p < 0.001), and 0.795 for renal failure (95% CI, 0.749–0.841; p < 0.001)