Management of Acutely Symptomatic Hernia

Emergencies Clinical Trial

— MASH  

Official title:

Management of Acutely Symptomatic Hernia: An Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04197271
• Other study ID #: STH20908
• Status: Active, not recruiting
• Start date: March 3, 2020
• Est. completion date: March 24, 2021

Study information

• Verified date: January 2021
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: March 24, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hernia
• Surgery--Complications

Intervention

Procedure:
• Emergency Hernia Repair
Emergency repair of hernia using method selected by treating surgeon.

Other:
• Conservative management
Treatment of hernia without resort to surgery

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In hospital morbidity	As defined using the comprehensive complication index	up to 28 days after surgery
Secondary	Mortality	Death occuring (binary)	Measured at baseline, 30 days post discharge, and 90 days post recruitment
Secondary	Hospital length of stay	Time from admission to discharge measured in days	Within 30 days of recruitment to study
Secondary	Unplanned readmission within 30 days	Unplanned readmission to hospital for any reason following treatment of hernia	Up to 30 days of recruitment
Secondary	Change in health utility	Measured using EQ-5D-5L questionnaire	Measured at baseline, 30 days post discharge and 90-days post recruitment