Clinical Trial: Geographic Influences on Emergency Laparotomy Outcomes

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Geographic Influences on Emergency Laparotomy Outcomes

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.


Detailed Summary:

The aim of this study is to explore the possibility that outcomes from emergency laparotomy may vary according to:

  1. the urban-rural nature of the patient's home location and
  2. travel time from hospital.

This is a retrospective study of all emergency laparotomies performed in Scotland during the period from 1st January 2001 - 31st December 2010. It will use routinely collected administrative data from the Information Services Division (ISD) of NHS National Services Scotland.

Emergency laparotomy will be defined as a non-elective abdominal procedure primarily on the gut tube; and such cases will be identified by the use of a set of procedural codes, which will be validated against local records.

Potentially significant confounding variables such as age, gender, and co-morbidity will be studied for their predictive value in a univariate model and included in a multivariate model if they remain significant. 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.

The registry which will supply the data for this study is the Scottish Morbidity Record 01 (SMR01), the full title of which is the "General / Acute Inpatient and Day Case dataset" (see http://www.adls.ac.uk/nhs-scotland/general-acute-inpatient-day-case-smr01/?detail). SMR01 is collated and administered by ISD, and data submission is mandatory for all Scottish NHS providers of in-patient or day-case care. Approximately 1.4 million records are added each year. Diagnoses are coded according to Interna
Sponsor: University of Edinburgh

Current Primary Outcome: Mortality [ Time Frame: Either within 30 days of procedure, or during continuous in-patient stay ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Post-operative length of stay [ Time Frame: From date of laparotomy to date of discharge (whole days) - see below ]
    (Whole) days from date of laparotomy to date of discharge. Because this is a retrospective study using a complete national data set, with the last admission 2.5 years distant from the time of data collection, we will use actual time period rather than censoring length of stay at a set point.
  • Re-operation [ Time Frame: Within the index admission or within 30 days of discharge ]
    The occurrence of an abdominal procedure either subsequent to laparotomy and within the index admission, or ≤30 days of discharge.
  • Re-admission [ Time Frame: Within 30 days of index discharge ]
    Re-admission to any hospital specialty ≤30 days have elapsed since date of discharge.


Original Secondary Outcome: Same as current

Information By: University of Edinburgh

Dates:
Date Received: November 21, 2013
Date Started: January 2001
Date Completion:
Last Updated: December 16, 2013
Last Verified: December 2013