Clinical trial NCT04197271: Management of Acutely Symptomatic Hernia
Official title: Management of Acutely Symptomatic Hernia: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hernia
Emergencies
Surgery--Complications
Keywords: outcome
hernia
emergency
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be identified from attendance at UK hospitals which provide emergency surgical services.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: In hospital morbidity
timeFrame: up to 28 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: Measured at baseline, 30 days post discharge, and 90 days post recruitment
measure: Hospital length of stay
timeFrame: Within 30 days of recruitment to study
measure: Unplanned readmission within 30 days
timeFrame: Up to 30 days of recruitment
measure: Change in health utility
timeFrame: Measured at baseline, 30 days post discharge and 90-days post recruitment
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Matthew J Lee, MRCS PhD
role: PRINCIPAL_INVESTIGATOR
References: