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临床试验/NCT04197271
NCT04197271已完成不适用

Management of Acutely Symptomatic Hernia: An Observational Study

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年3月3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
280
试验地点
2
主要终点
In hospital morbidity

研究概览

简要总结

Acutely symptomatic abdominal wall hernia can cause many symptoms and complications. They can be associated with levels of morbidity beyond that seen in emergency laparotomy. There is limited data to guide practice in this field. This observational cohort study will explore variation in practice around assessment, repair and outcomes of hernias treated in the emergency setting.

详细描述

There are many different types of hernia, with the most common being in the groin or at the umbilicus. Hernias affect a significant proportion of the population and can vary from producing no symptoms at all, to causing a blockage to the bowel that requires urgent surgery. Hernias affect people of all ages and degrees of health, but become increasingly common with age. As our population ages and therefore becomes generally more unwell, the risks of surgery increase. Recent evidence suggests that emergency hernia repair is associated with worse outcomes than planned procedures. At present there are limited guidelines for the management of acutely symptomatic hernias and therefore practice varies between hospitals.

This cohort study will capture information on patients treated in the UK for acutely symptomatic hernia, and will provide information on variation in assessment, and technical aspects of repair. It will also capture health utility data out to 90 days post discharge from hospital.

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 aged 18 years and over
  • Patients admitted directly to the emergency surgery service (via A+E or GP)
  • Patients referred to the emergency surgical team by another inpatient specialty
  • Patients with a diagnosis of an acutely symptomatic hernia made by a specialist surgical trainee (ST3+) or Consultant Surgeon
  • Willing to take part in the study

排除标准

  • Patients under 18 years of age
  • Pregnant women
  • Patients with a symptomatic parastomal, hiatal or diaphragmatic hernia
  • Patients with a traumatic hernia
  • Unable to consent

结局指标

主要结局

In hospital morbidity

时间窗: up to 28 days after surgery

As defined using the comprehensive complication index

次要结局

  • Mortality(Measured at baseline, 30 days post discharge, and 90 days post recruitment)
  • Change in health utility(Measured at baseline, 30 days post discharge and 90-days post recruitment)
  • Hospital length of stay(Within 30 days of recruitment to study)
  • Unplanned readmission within 30 days(Up to 30 days of recruitment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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