【ChiCTR2200056183】Hajibandeh Index versus NELA Score in Predicting Mortality Following Emergency Laparotomy: a medical records based study

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基本信息

登记号

ChiCTR2200056183

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2022-02-01

临床申请受理号

靶点

适应症

Acute abdominal pathology requiring emergency laparotomy

试验通俗题目

Hajibandeh Index versus NELA Score in Predicting Mortality Following Emergency Laparotomy: a medical records based study

试验专业题目

Predictive Significance of Hajibandeh Index

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

CF72 8XR

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临床试验信息

试验目的

Emergency laparotomy carries a high risk of morbidity and mortality.1 Modern predictors of mortality following emergency laparotomy include age over 80, American Society of Anesthesiologists (ASA) status above 3, sarcopenia (age-related loss of skeletal muscle mass), presence of intraperitoneal contamination, and the need for a bowel resection.2-4 In order to identify patients at high risk of morbidity and mortality following emergency laparotomy, there has been increasing effort to develop and validate accurate risk-prediction models over recent years. An accurate risk-prediction model would facilitate the preoperative risk assessment, the prediction of the need for perioperative support in critical care units, objective discussion between patients and relatives and multidisciplinary decision making when deciding on operative or non-operative treatment high risk patients. Commonly used risk-prediction models for predicating mortality following emergency laparotomy include the Portsmouth-physiological and operative severity score for the enumeration of mortality and morbidity (P-POSSUM)5 and the National Emergency Laparotomy Audit (NELA) score.6 Although P-POSSUM was initially the most commonly used model for predicting mortality following emergency laparotomy,7 it lost its popularity due to concerns about inaccuracy in some subgroups of patients and potential overestimation of mortality.8,9 The predictive value of the NELA score and P-POSSUM model have been compared recently and the routine use of NELA model instead of P-POSSUM has been recommended.10,11 The Hajibandeh Index (HI), which is derived from combined levels of C-reactive protein (CRP), lactate, neutrophils, lymphocytes and albumin, was developed and validated in our previous studies.12,13 It was shown that HI predicts the presence of intraperitoneal contamination in patients with acute abdominal pathology and postoperative mortality in patients undergoing emergency laparotomy.12 The HI includes levels of CRP, neutrophils and lactate as nominator considering the fact that their levels increase in presence of abdominal sepsis. It includes levels of albumin and lymphocytes as denominators because their levels decrease in presence of abdominal sepsis.12, 13 In this study we aimed to compare the performance of the HI and NELA model in predicting postoperative mortality in patients undergoing emergency laparotomy. Moreover, we aimed to reassess the performance of HI in predicting the nature and presence of peritoneal contamination.

试验分类

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试验类型

连续入组

试验分期

回顾性研究

随机化

Not applicable as the study was retrospective cohort study

盲法

N/A

试验项目经费来源

This research receives no specific grant from any funding agency in the public, commercial, or not-for-profit organisations.

试验范围

目标入组人数

700

实际入组人数

第一例入组时间

2021-11-01

试验终止时间

2021-12-31

是否属于一致性

入选标准

All patients aged over 18 who underwent emergency laparotomy in our centre between January 2014 to January 2021 were considered eligible for inclusion. The indications of interest for emergency laparotomy included small bowel obstruction, large bowel obstruction, visceral perforation, intestinal ischaemia, intraabdominal collection, intraabdominal bleeding, and intraabdominal sepsis of any source (anastomotic leak, colitis, intestinal fistula). The list of procedures of interest during emergency laparotomy was not exhaustive and included colectomies, small bowel resection, repair of perforated viscus, adhesiolysis, creation of defunctioning stoma, achievement of haemostasis, drainage of intraabdominal collection and peritoneal irrigation.；

排除标准

The patients who underwent laparotomy secondary to trauma were excluded. Moreover, patients who did not have available preoperative levels of CRP, neutrophils, lactate, lymphocytes or albumin and the patients with underlying haematological malignancy resulting in chronic elevated levels of neutrophils or lymphocytes were excluded.；

研究者信息

研究负责人姓名

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试验机构

Shahab Hajibandeh- Department of General Surgery, Royal Glamorgan Hospital

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

CF243AG

联系人通讯地址