Management of Acutely Symptomatic Hernia

NCT ID: NCT04197271

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2021-03-24

Brief Summary

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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

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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.

Conditions

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Hernia Emergencies Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acutely symptomatic abdominal wall hernia

Patients presenting to emergency surgical services with acutely symptomatic abdominal wall hernia (excluding parastomal).

Emergency Hernia Repair

Intervention Type PROCEDURE

Emergency repair of hernia using method selected by treating surgeon.

Conservative management

Intervention Type OTHER

Treatment of hernia without resort to surgery

Interventions

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Emergency Hernia Repair

Emergency repair of hernia using method selected by treating surgeon.

Intervention Type PROCEDURE

Conservative management

Treatment of hernia without resort to surgery

Intervention Type OTHER

Other Intervention Names

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Non-operative management

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J Lee, MRCS PhD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36633418 (View on PubMed)

Other Identifiers

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STH20908

Identifier Type: -

Identifier Source: org_study_id

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