The Hospital Volume Relationship in Appendicectomy Outcomes

Appendicitis Clinical Trial

Official title:

The Hospital Volume Relationship in Appendicectomy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018016
• Other study ID #: XRB13069-VA
• Status: Completed
• Start date: January 2001
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

This is a retrospective study of all appendicectomies 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.

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 recent 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 support team. Data completeness is very high in SMR01. However, where significant volumes of data are missing or unusable, the need for data imputation will be explored.

The study period was decided on pragmatically by a desire to provide an assessment of current practice, fully within the era of widely practised laparoscopic surgery. A power calculation also suggested that this would provide an adequate sample size to demonstrate differences.

Our power calculation- specific to length of stay- was based on Faiz O, Clark J, Brown T, Bottle A, Antoniou A, Farrands P, et al. Traditional and Laparoscopic Appendectomy in Adults. Ann Surg. 2008 Nov;248(5):800-6. In their cohort of 259,735 appendicectomies performed from 1996-2006, the geometric mean length of stay was 3.52, with SD 1.8. We decided that a difference of 0.5 days would be 'clinically significant'. We specified alpha 0.05 and Power 0.9, and an allocation ratio of 2 (allowing comparison of one tertile to two others). A two-sided t-test of difference between two independent means was performed in G*Power 3.1.7. This demonstrated that a total N of 616 was required to demonstrate this difference. According to ISD figures, there were 3,712 appendicectomy procedures performed in 2010/11, so we will be able to detect a clinically significant difference in length of stay.

Hospitals will be placed into tertiles of high, medium and low volume, according to the number of procedures performed over the study period.

In the absence of a literature standard appendicectomy outcome measure, the following will be assessed as primary outcome measures: 30 day/in-patient mortality, 30 day re-admission rate, 30 day re-operation rate, post-operative length of stay and negative appendicectomy rates between these 3 groups. Potentially significant confounding variables such as age, gender, and co-morbidity will be studied for their predictive value in a univariate model and included in a multivariate model if they remain significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40000
• Est. completion date: August 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure.

• Patients non-resident in Scotland

Related Conditions & MeSH terms

• Appendicitis

Locations

Country	Name	City	State
United Kingdom	All Scottish NHS Hospitals	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Re-admission	Re-admission to any hospital specialty =30 days have elapsed since date of discharge.	Within 30 days of index discharge
Primary	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
Primary	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