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临床试验/NCT04577339
NCT04577339已完成不适用

The BCAE Study: Best Care for Abdominal Emergencies

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,500
试验地点
1
主要终点
Mortality rates of different interventions

研究概览

简要总结

This is a single-centre retrospective cohort study utilising electronic hospital records.

The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not. Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020. The investigators will then identify patients who had an emergency laparotomy, and those who had a laparoscopic procedure. The investigators aim to identify 2 further groups where treatment is non-surgical (but could be medical or interventional radiology) or where treatment is considered futile, suggesting that an early focus on end of life care might be appropriate. The primary objective is to provide mortality rates for different treatment options, and analysis of short- and long-term outcomes. The secondary endpoints are to define patient sub-groups with similar health characteristics based on clinical data and an established risk index and to use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow the investigators to identify the best care pathways for each cluster.

详细描述

Abdominal emergencies are common, involving perforation, obstruction or ischaemia of the bowel, often needing life-saving emergency surgery, with a large incision to access the abdominal cavity called "laparotomy". This procedure is high risk with 10% mortality rate. 30,000 emergency laparotomies are performed each year in England and Wales. Since 2013, the National Emergency Laparotomy Audit (NELA) has set standards of care and monitored outcomes for emergency laparotomy, which has reduced mortality from 11.8 to 9.5%. However, patients who do NOT have a laparotomy are not well characterised and do not receive the prioritised care patients having surgery do, even though their condition is no less severe. Initial research has shown a surprisingly large group of patients (32%) with an intestinal emergency do not have surgery and have 30-day mortality of 63%. There are three additional groups of patients admitted with abdominal emergencies: patients having keyhole surgery or interventional radiological procedures, and patients for whom any treatment would be futile and would benefit most from an end of life care pathway. Clearly further work is needed to investigate the management of ALL patients with intestinal emergency, to optimise care for each group of patients.The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not.

AIM:

This is a single-centre retrospective cohort study utilising electronic hospital records.

STUDY DESIGN:

Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All acute general surgical adult patients admitted between 2013 and 2020 with all of the conditions below:
  • •Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes
  • •Must be >= 16 years of age at the time of admission
  • •Have at least one full set of vital signs recorded on the day of admission
  • •Have at least one full set of routine blood tests recorded on the day of admission

排除标准

  • •Maternity admissions during/after pregnancy
  • •Patients admitted or undergoing abdominal surgery for a second time or more

结局指标

主要结局

Mortality rates of different interventions

时间窗: 2013-2020

Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.

次要结局

  • Define patient sub-groups with similar health characteristics(2013-2020)
  • Predict the risk of death for each patient group(2013-2020)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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