Management of Acutely Symptomatic Hernia

• Conditions: Hernia; Emergencies; Surgery--Complications
• Interventions: Procedure: Emergency Hernia Repair; Other: Conservative management

• Registration Number: NCT04197271
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-13
• Study Start: 2020-03-03
• Primary Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06
• Study Completion: 2021-03-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acutely symptomatic abdominal wall hernia	Emergency Hernia Repair	Patients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal).
Patients with acutely symptomatic abdominal wall hernia	Conservative management	Patients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal).

Primary Outcome Measures

Name	Time	Method
In hospital morbidity	up to 28 days after surgery	As defined using the comprehensive complication index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom