Management of Acutely Symptomatic Hernia (MASH)

Management of Acutely Symptomatic Hernia: An Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergencies; Hernia; Surgery--Complications
• Intervention / Treatment: Procedure: Emergency Hernia Repair; Other: Conservative management

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 Type: Observational
• Enrollment (Actual): 280

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified from attendance at UK hospitals which provide emergency surgical services.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with acutely symptomatic abdominal wall hernia; Patients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal).	Procedure: Emergency Hernia Repair; Emergency repair of hernia using method selected by treating surgeon.; Other: Conservative management; Treatment of hernia without resort to surgery; Other Names: Non-operative management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In hospital morbidity	As defined using the comprehensive complication index	up to 28 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Matthew J Lee, MRCS PhD, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Anticipated): March 24, 2021

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: outcome; hernia; emergency
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Emergencies; Hernia
• Other Study ID Numbers: STH20908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No