Geographic Influences on Appendicectomy Outcomes

NCT02017951 | Completed

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

Brief Summary

Introduction 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 outcomes following appendicectomy which may be explained by geographic factors. Aims The aim of this study is to describe appendicectomy 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 procedure code for appendicectomy, and the urban-rural classification of patients will be derived from postcode data. Travel time from hospital will also be estimated through postcode data. The investigators will study a 10 year period 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 rates.

Conditions

Appendicitis

Keywords

Appendectomy; Hospitals,General; Hospitals,Rural; Hospitals,Urban; Rural Health Services; Geography, Medical; 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 (9)

Urban-Rural Classification 1: Large Urban Areas

Settlements of over 125,000 people.

Urban-Rural Classification 2: Other Urban Areas

Settlements of 10,000 to 125,000 people.

Urban-Rural Classification 3: Accessible Small Towns

Settlements of between 3,000 and 10,000 people and within 30 minutes drive of a settlement of 10,000 or more.

Urban-Rural Classification 4: Remote Small Towns

Settlements of between 3,000 and 10,000 people and with a drive time of over 30 minutes to a settlement of 10,000 or more.

Urban-Rural Classification 5: Very Remote Small Towns

Settlements of between 3,000 and 10,000 people and with a drive time of over 60 minutes to a settlement of 10,000 or more.

Urban-Rural Classification 6: Accessible Rural

Areas with a population of less than 3,000 people, and within a 30 minute drive time of a settlement of 10,000 or more.

Urban-Rural Classification 7: Remote Rural

Areas with a population of less than 3,000 people, and with a drive time of over 30 minutes to a settlement of 10,000 or more.

Urban-Rural Classification 8: Very Remote Rural

Areas with a population of less than 3,000 people, and with a drive time of over 60 minutes to a settlement of 10,000 or more.

Travel Time - see below

Travel time will be analysed as both a continuous and discrete variable.

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

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)