The Hospital Volume Relationship in Emergency Laparotomy Outcomes

NCT02047812 | Completed

• 1 other identifier: XRB13069-VEL
• 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 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.

Conditions

Abdomen, Acute

Keywords

Laparotomy; General Surgery; Hospitals,General; Hospitals,High-Volume; Hospitals,Low-Volume; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-operative length of stay

  From date of laparotomy to date of discharge (whole days) - up to 12.5 years

• Re-operation

  Within the index admission (theoretically, up to a maximum of 12.5 years) or within 30 days of discharge

• Re-admission

  Within 30 days of index discharge

Study Arms (3)

High volume hospitals

The hospitals in the upper tertile for procedural volume

Medium volume hospitals

The hospitals in the middle tertile for procedural volume

Low volume hospitals

The hospitals in the lowest tertile for procedural volume.

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

Multiple Locations, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Please note with regard to enrollment: that although this study period has ended and data is being collated, the actual number of subjects is not known at this point since data has yet to be received. We requested data on all subjects meeting our criteria within the time frame mentioned.

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: December 16, 2013
• First Posted: January 28, 2014
• Study Start: January 1, 2001
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2013
• Last Updated: May 21, 2024

Record last verified: 2014-01

Locations

GB (1)