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OpenTrials
Completed

NCT Number: NCT04197271

Management of Acutely Symptomatic Hernia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emergency hernia repair

Procedure

Emergency repair of hernia using method selected by treating surgeon.

Conservative management

Other

Treatment of hernia without resort to surgery

Other names: Non-operative management

Primary outcomes

  1. In hospital morbidity

    Time frame: up to 28 days after surgery

    As defined using the comprehensive complication index

Secondary outcomes

  1. Mortality

    Time frame: Measured at baseline, 30 days post discharge, and 90 days post recruitment

    Death occuring (binary)

  2. Hospital length of stay

    Time frame: Within 30 days of recruitment to study

    Time from admission to discharge measured in days

  3. Unplanned readmission within 30 days

    Time frame: Up to 30 days of recruitment

    Unplanned readmission to hospital for any reason following treatment of hernia

  4. Change in health utility

    Time frame: Measured at baseline, 30 days post discharge and 90-days post recruitment

    Measured using EQ-5D-5L questionnaire

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Management of Acutely Symptomatic Hernia: An Observational Study

Acronym: MASH

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 13, 2019
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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