Clinical Trial: The Hospital Volume Relationship in Emergency Laparotomy Outcomes

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

Official Title: The Hospital Volume Relationship in 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 differences in hospital procedural volume.

Aims

The aim of this study is to compare emergency laparotomy outcomes in Scotland as they vary by hospital procedural volume.

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.

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 length of stay.

Detailed Summary:

The aim of this study is to explore the possibility of a hospital procedural volume-outcome relationship in Scottish emergency laparotomy outcomes.

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.

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 International Classification of Diseases (ICD)-10 standards and procedures are coded according to the United Kingdom's Office of Population Census Statistics (OPCS) standards, the most current of which is version 4.5. The data quality in SMR01 is high and is assured by regular internal audits. In the 2010 audit of accuracy, Main Condition was recorded with an accuracy of 88% and Main Procedure was recorded with an accuracy of 94%.

Where data inconsistencies are identified in the extract supplied for this study, further clarification will be obtained where possible with ISD's data retrieval sup
Sponsor: University of Edinburgh

Current Primary Outcome: Mortality [ Time Frame: Either within 30 days of procedure, or during continuous in-patient stay (up to 12.5 years) ]

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) - up to 12.5 years ]

  (Whole) days from date of laparotomy to date of discharge. B

  This is a retrospective study using a complete national data set, with the first admission 12.5 years distant from the time of data collection, and the last admission 2.5 years prior to the time of data collection. The theoretical maximal length of stay is 12.5 years.

• Re-operation [ Time Frame: Within the index admission (theoretically, up to a maximum of 12.5 years) 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.

  As above, this is a retrospective study using a complete national data set, with the first admission 12.5 years distant from the time of data collection, and the last admission 2.5 years prior to the time of data collection. The theoretical maximal length of stay for the index admission is 12.5 years.

• 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: December 16, 2013
Date Started: January 2001
Date Completion:
Last Updated: January 24, 2014
Last Verified: January 2014