Abdomen, Acute Clinical Trial
Official title:
The Hospital Volume Relationship in Emergency Laparotomy Outcomes
NCT number | NCT02047812 |
Other study ID # | XRB13069-VEL |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2001 |
Est. completion date | August 2013 |
Verified date | January 2014 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40000 |
Est. completion date | August 2013 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients aged 18 years or older who undergo emergency laparotomy within the study period Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | All Scottish NHS Hospitals | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Death as an in-patient or =30 days of procedure.
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. 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 (up to 12.5 years) | |
Secondary | Post-operative length of stay | (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. |
From date of laparotomy to date of discharge (whole days) - up to 12.5 years | |
Secondary | Re-operation | 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. |
Within the index admission (theoretically, up to a maximum of 12.5 years) or within 30 days of discharge | |
Secondary | Re-admission | Re-admission to any hospital specialty =30 days have elapsed since date of discharge. | Within 30 days of index discharge |
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