Geographic Influences on Emergency Laparotomy Outcomes

NCT02017977 | Completed

• 1 other identifier: XRB13069-GEL
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction 'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which are known to carry a significant risk of mortality and morbidity. Previous work has shown considerable inter-hospital variation in emergency laparotomy outcomes within the United Kingdom. It is unknown whether there are significant differences in outcomes following laparotomy which may be explained by geographic factors. Aims The aim of this study is to describe emergency laparotomy outcomes in Scotland as they vary by the urban-rural nature of the patient's home location and travel time from hospital. Methods This research study is a retrospective observational enquiry which will utilise administrative data from the Information Services Division (ISD) of NHS National Services Scotland. Patient episodes will be identified by a set of procedure codes for emergency laparotomy, and the urban-rural classification of patients will be derived from postcode data. Travel time from hospital will also be derived from postcode data. The investigators will study a 10 year period from January 2001 to December 2010. The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary outcome measures will be 30 day readmission rate, 30 day re-operation rate and post-operative length of stay.

Conditions

Abdomen, Acute

Keywords

Laparotomy; General Surgery; Hospitals,General; Hospitals,Rural; Hospitals,Urban; Rural Health Services; Geography, Medical; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death as an in-patient or ≤30 days of procedure. Deaths will be recognised from SMR01 which is linked to the Registrar General's database of deaths.

  Either within 30 days of procedure, or during continuous in-patient stay

Secondary Outcomes (3)

• Post-operative length of stay

  From date of laparotomy to date of discharge (whole days) - see below

• Re-operation

  Within the index admission or within 30 days of discharge

• Re-admission

  Within 30 days of index discharge

Study Arms (9)

Urban-Rural Classification 1: Large Urban Areas

Settlements of over 125,000 people

Urban-Rural Classification 2: Other Urban Areas

Settlements of 10,000 to 125,000 people

Urban-Rural Classification 3: Accessible Small Towns

Settlements of between 3,000 and 10,000 people and within 30 minutes drive of a settlement of 10,000 or more.

Urban-Rural Classification 4: Remote Small Towns

Settlements of between 3,000 and 10,000 people and with a drive time of over 30 minutes to a settlement of 10,000 or more.

Urban-Rural Classification 5: Very Remote Small Towns

Settlements of between 3,000 and 10,000 people and with a drive time of over 60 minutes to a settlement of 10,000 or more

Urban-Rural Classification 6: Accessible Rural

Areas with a population of less than 3,000 people, and within a 30 minute drive time of a settlement of 10,000 or more

Urban-Rural Classification 7: Remote Rural

Areas with a population of less than 3,000 people, and with a drive time of over 30 minutes to a settlement of 10,000 or more

Urban-Rural Classification 8: Very Remote Rural

Areas with a population of less than 3,000 people, and with a drive time of over 60 minutes to a settlement of 10,000 or more

Travel Time - see below

Travel time will be analysed as a continuous and discrete variable.

Eligibility Criteria

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

Study Population

All Scottish adult residents undergoing emergency laparotomy during the study period

You may qualify if:

• All patients aged 18 years or older who undergo emergency laparotomy within the study period

You may not qualify if:

• Patients who are non-resident in Scotland
• Multiple laparotomies on a single patient will not be counted as separate index events unless ≥6 months have passed between previous discharge and new hospital admission.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

All Scottish NHS Hospitals

All Scottish Surgical Units, United Kingdom

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Ewen M Harrison, FRCS, PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2001
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

GB (1)