The Hospital Volume Relationship in Appendicectomy Outcomes

NCT02018016 | Completed

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

Brief Summary

Background Appendicitis is a common condition which represents a significant resource burden for the Scottish National Health Service (NHS). It is unknown whether there are significant differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by hospital volume. In many studies, hospital procedural volume has been shown to be predictive of surgical outcomes. Aims The aim of this study is to compare appendicectomy 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 procedure codes for appendicectomy. A 10 year period will be studied, from January 2001 to December 2010. Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.

Conditions

Appendicitis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Post-operative length of stay

  (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.

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

• Re-operation

  The occurrence of an abdominal procedure either subsequent to appendicectomy and within the index admission, or ≤30 days of discharge.

  Within the index admission or within 30 days of discharge

• Re-admission

  Re-admission to any hospital specialty ≤30 days have elapsed since date of discharge.

  Within 30 days of index discharge

• 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

• Negative Appendicectomy Rate

  The rate of appendicectomies performed in which the appendix is found to be normal. This will be detected by the use of ICD-10 codes.

  At time of index procedure

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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All Scottish residents undergoing appendicectomy during the study period.

You may qualify if:

• All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 - December 2010.

You may not qualify if:

• Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure.
• Patients non-resident in Scotland

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

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

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: May 21, 2024

Record last verified: 2013-12

Locations

GB (1)