Management of Acutely Symptomatic Hernia

Overview

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.

Full Title of Study: “Management of Acutely Symptomatic Hernia: An Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2020

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.

Interventions

  • Procedure: Emergency Hernia Repair
    • Emergency repair of hernia using method selected by treating surgeon.
  • Other: Conservative management
    • Treatment of hernia without resort to surgery

Arms, Groups and Cohorts

  • Patients with acutely symptomatic abdominal wall hernia
    • Patients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal).

Clinical Trial Outcome Measures

Primary Measures

  • In hospital morbidity
    • Time Frame: up to 28 days after surgery
    • As defined using the comprehensive complication index

Secondary Measures

  • Mortality
    • Time Frame: Measured at baseline, 30 days post discharge, and 90 days post recruitment
    • Death occuring (binary)
  • Hospital length of stay
    • Time Frame: Within 30 days of recruitment to study
    • Time from admission to discharge measured in days
  • Unplanned readmission within 30 days
    • Time Frame: Up to 30 days of recruitment
    • Unplanned readmission to hospital for any reason following treatment of hernia
  • Change in health utility
    • Time Frame: Measured at baseline, 30 days post discharge and 90-days post recruitment
    • Measured using EQ-5D-5L questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Matthew J Lee, MRCS PhD, Principal Investigator, Sheffield Teaching Hospitals NHS Foundation Trust

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