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Dr. Shahab Hajibandeh, Please contact us (chictr002@chictr.org.cn) to upload the Approved file of Ethical Committee. Hajibandeh Index versus NELA Score in Predicting Mortality Following Emergency Laparotomy: a medical records based study
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注册号：

Registration number：

 ChiCTR2200056183 

最近更新日期：

Date of Last Refreshed on：

 2024-08-11 22:27:29 

注册时间：

Date of Registration：

 2022-02-01 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Dr. Shahab Hajibandeh, Please contact us (chictr002@chictr.org.cn) to upload the Approved file of Ethical Committee. Hajibandeh Index versus NELA Score in Predicting Mortality Following Emergency Laparotomy: a medical records based study

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Predictive Significance of Hajibandeh Index

Scientific title：

Hajibandeh Index versus NELA Score in Predicting Mortality Following Emergency Laparotomy

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Shahab Hajibandeh 

研究负责人：

Shahab Hajibandeh 

Applicant：

Shahab Hajibandeh 

Study leader：

Shahab Hajibandeh 

申请注册联系人电话：

Applicant telephone：

 +447766106423

研究负责人电话：

Study leader's
telephone：

+447766106423

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 shahab_hajibandeh@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 shahab_hajibandeh@yahoo.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

shahab_hajibandeh@yahoo.com

研究负责人通讯地址：

Royal Glamorgan Hospital

Applicant address：

Royal Glamorgan Hospital, Ynysmaerdy, Pontyclun

Study leader's address：

Royal Glamorgan Hospital, Ynysmaerdy, Pontyclun

申请注册联系人邮政编码：

Applicant postcode：

 CF72 8XR

研究负责人邮政编码：

Study leader's postcode：

 CF243AG

申请人所在单位：

英国皇家格那摩根医院

Applicant's institution：

Department of General Surgery, Royal Glamorgan Hospital

研究负责人所在单位：

英国皇家格那摩根医院

Affiliation of the Leader：

Department of General Surgery, Royal Glamorgan Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Shahab Hajibandeh- Department of General Surgery, Royal Glamorgan Hospital

Primary sponsor：

Shahab Hajibandeh- Department of General Surgery, Royal Glamorgan Hospital

研究实施负责（组长）单位地址：

Shahab Hajibandeh- Department of General Surgery, Royal Glamorgan Hospital

Primary sponsor's address：

Shahab Hajibandeh- Department of General Surgery, Royal Glamorgan Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

Province：

City：

单位(医院)：

具体地址：

Institution
hospital：

Address：

经费或物资来源：

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

Source(s) of funding：

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

研究疾病：

Acute abdominal pathology requiring emergency laparotomy  

Target disease：

Acute abdominal pathology requiring emergency laparotomy

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

The study does not involve any treatment. It compares the following risk-prediction tools Hajibandeh Index. Hajibandeh Index (HI) includes preoperative levels of CRP, neutrophils and lactate as nominators and preoperative levels of albumin and lymphocytes as denominators.12 NELA risk score. The NELA model includes patient characteristics (age and gender), ASA status, preoperative laboratory tests (haemoglobin, white blood cell count sodium, potassium, creatinine, and urea), heart rate, systolic blood pressure, the Glasgow coma score, cardiac and respiratory signs, operative severity, peritoneal soiling, intraoperative blood loss, severity of malignancy, and urgency of surgery.15  

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2021-11-01 00:00:00至 To 2021-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2014-01-01 00:00:00 至 To 2021-01-01 00:00:00

干预措施：

Interventions：

组别：

Hajibandeh Index

样本量：

 700

Group：

Hajibandeh Index

Sample size：

干预措施：

NELA risk score

干预措施代码：

Intervention：

NELA risk score

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 英国

省(直辖市)：

 Cardiff 

市(区县)：

  

Country：

United Kingdom

Province：

Cardiff

City：

单位(医院)：

 Royal Glamorgan Hospital 

单位级别：

 Secondary Care 

Institution
hospital：

Royal Glamorgan Hospital

Level of the institution：

Secondary Care

测量指标：

Outcomes：

指标中文名：

30-day mortality

指标类型：

主要指标

Outcome：

30-day mortality

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

90-day mortality

指标类型：

次要指标

Outcome：

90-day mortality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Presence and nature of contamination

指标类型：

附加指标

Outcome：

Presence and nature of contamination

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 94 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Not applicable as the study was retrospective cohort study

Randomization Procedure (please state who generates the random number sequence and by what method)：

Not applicable as the study was retrospective cohort study

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

Not applicable as the study was retrospective cohort study

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

None

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

An electronic proforma was created that collected data on the following parameters: patients’ demographic data (age and sex), ASA status, indication for emergency laparotomy, performed procedure, components of the HI, components of the NELA score, presence and nature of intraperitoneal contamination, 30-day mortality and 90-day mortality. All steps of the data collection were performed by two independent authors and an independent third author was consulted in the event of disagreement. The authors who were involved in data collection were not involved in data analyses.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

An electronic proforma was created that collected data on the following parameters: patients’ demographic data (age and sex), ASA status, indication for emergency laparotomy, performed procedure, components of the HI, components of the NELA score, presence and nature of intraperitoneal contamination, 30-day mortality and 90-day mortality. All steps of the data collection were performed by two independent authors and an independent third author was consulted in the event of disagreement. The authors who were involved in data collection were not involved in data analyses.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-02-01 10:36:21
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