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临床试验/NCT05688501
NCT05688501已完成不适用

Development of a New Reliable, Easy and Reproducible Clinical-biological Scale Allowing to Select Patients Consulting in the Emergency Department for Upper Gastrointestinal Bleeding

Hôpital Universitaire Sahloul1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年9月1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
150
试验地点
1
主要终点
re-bleeding

研究概览

简要总结

Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality.

The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality rates of 2%-8%.

While Lower Gastrointestinal Bleeding (LBHB) has a lower incidence estimated at 33 per 100,000 adults per year. Additionally, compared to HDB, HDB appears to have less need for hemostatic intervention and lower mortality.

详细描述

Gastrointestinal bleeding is a frequent reason for consultation in the Emergency Department. It is a real emergency associated with fairly significant morbidity and mortality.

The incidence of upper gastrointestinal bleeding (HDH) has been reported to be 67-103 per 100,000 adults per year in the UK with mortality rates of 2%-8%.

While Lower Gastrointestinal Bleeding (LBHB) has a lower incidence estimated at 33 per 100,000 adults per year. Additionally, compared to HDB, HDB appears to have less need for hemostatic intervention and lower mortality.

Despite a decrease in incidence, the first cause of upper gastrointestinal bleeding remains peptic ulcer. That of lower digestive hemorrhage is diverticular hemorrhage, the incidence of which increases with the aging of the population.

Over time, the overall management of these haemorrhages has improved, in particular with better availability of endoscopic exploration from the emergency room consultation. However, the average time for digestive endoscopy was reported at 16 hours in a North African study published in 2012. Measures should be put in place to further improve access to endoscopy services for these patients, being given that a fifth of them received this care with delays exceeding 48 to 72 hours.

研究设计

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

入排标准

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

入选标准

  • Patients over the age of 18 consulting the emergency department of Sahloul Hospital in Sousse for exteriorized upper and/or lower digestive haemorrhage, of non-traumatic cause;

排除标准

  • patient under the age of 18
  • diagnosis of external hemorrhoids / perianal lesions
  • Not consenting
  • The lost sight

结局指标

主要结局

re-bleeding

时间窗: 30 days

Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days

re-hospitalization

时间窗: 30 days

re- hospitalisation for Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days

comparaison with the glasgow blatchford score

时间窗: 30 days

comparaison with the glasgow blatchford score

All cause mortality

时间窗: 30 days

The primary outcome was all-cause in-hospital mortality rate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riadh Boukef

Professor

Hôpital Universitaire Sahloul

研究点 (1)

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