Management of Acutely Symptomatic Hernia

NCT04197271 | Unknown

• 1 other identifier: STH20908
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia; Emergencies; Surgery--Complications

Keywords

outcome; hernia; emergency

Outcome Measures

Primary Outcomes (1)

• In hospital morbidity

  As defined using the comprehensive complication index

  up to 28 days after surgery

Secondary Outcomes (4)

• Mortality

  Measured at baseline, 30 days post discharge, and 90 days post recruitment

• Hospital length of stay

  Within 30 days of recruitment to study

• Unplanned readmission within 30 days

  Up to 30 days of recruitment

• Change in health utility

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

Study Arms (1)

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; Other: Conservative management

Interventions

Emergency Hernia Repair PROCEDURE

Emergency repair of hernia using method selected by treating surgeon.

Patients with acutely symptomatic abdominal wall hernia

Conservative management OTHER

Treatment of hernia without resort to surgery

Also known as: Non-operative management

Patients with acutely symptomatic abdominal wall hernia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (1)

• Proctor VK, O'Connor OM, Burns FA, Green S, Sayers AE, Hawkins DJ, Smart NJ, Lee MJ; MASH Collaborators. Surgical site infections after emergency hernia repair: substudy from the Management of Acutely Symptomatic Hernia (MASH) study. BJS Open. 2023 Jan 6;7(1):zrac155. doi: 10.1093/bjsopen/zrac155.

  PMID: 36633418 DERIVED

MeSH Terms

Conditions

Hernia; Emergencies

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Matthew J Lee, MRCS PhD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: December 13, 2019
• Study Start: March 3, 2020
• Primary Completion: November 30, 2020
• Study Completion: March 24, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)