A Comparison of Appendicectomy Outcomes in Children Between Paediatric and General Surgical Centres in Scotland

NCT02047786 | Completed

• 1 other identifier: XRB13069-PGA
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Appendicectomy (or appendectomy in US usage) is the single most commonly performed emergency surgical operation performed on British children. Previous investigation of outcomes following appendicectomy has suggested that specialist surgeons and high volume centres have fewer "negative" appendicectomies (i.e. the appendix found to be non-diseased), although there has not been consistent association found between hospital type or surgeon experience and complication rate or admission rate. Scotland has 3 dedicated children's surgery centres but straightforward children's surgery such as appendicectomy is also carried out in the country's general surgical centres. Appendicectomy outcome variations have not been explored in the Scottish National Health Service (NHS). Aim This study will compare appendicectomy outcomes in children between Scotland's specialist paediatric centres and general surgical centres. Methods This is a retrospective study of all appendicectomies performed in Scotland during the period from 1st January 2001 - 31st December 2010, on children aged 2 - 12 years old. It will use routinely collected administrative data from the Information Services Division of NHS National Services Scotland. The study will compare risk-adjusted 30 day/in-patient mortality, 30 day re-admission rate, 30 day re-operation rate, post-operative length of stay and negative appendicectomy rates.

Conditions

Appendicitis

Keywords

Outcome Assessment (Health Care); Appendectomy; Child; Hospitals, Pediatric; Hospitals, General

Outcome Measures

Primary Outcomes (5)

• Post-operative length of stay

  (Whole) days from date of laparotomy to date of discharge. 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.

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

• Re-operation

  The occurrence of an abdominal procedure either subsequent to appendicectomy and within the index admission, or ≤30 days of discharge. As stated in the previous outcome measure, 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. So the theoretical maximum time in which this outcome is measured is 12.5 years.

  Within the index admission (censored beyond a maximum of 12.5 years) 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. 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. 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)

• 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 (2)

General Hospital Patients

Those patients undergoing appendicectomy in a general (non-specialised) surgical centre.

Paediatric Hospital Patients

Those patients undergoing appendicectomy in specialised paediatric centres.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All children resident in Scotland, who undergo appendicectomy during the study period specified.

You may qualify if:

• All patients aged 2 - 12 years old who within the 10 year period of January 2001 - December 2010 are entered on the SMR01 database as having a code for appendicectomy.
• Episodes will be extracted with the following codes:
• OPCS (Office of Population Censuses and Surveys), revision 4.5
• H01 Emergency excision of appendix

You may not qualify if:

• We will exclude patients for whom incidental appendicectomy has occurred at the same time as another major abdominal surgical procedure.
• We will exclude patients who are non-resident in Scotland since we will be unable to derive depravity index and urban-rural classification, and may not have access to information on co-morbidities and mortality.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

All Scottish NHS Hospitals

All Scottish Surgical Facilities, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Please note that the investigators are not yet in receipt of the database required for this study. Although the study period has ended, we are not able at present to state how many patient episodes this database has captured.

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: 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: January 28, 2014

Record last verified: 2014-01

Locations

GB (1)