AppendicitisNCT02047786
A Comparison of Appendicectomy Outcomes in Children Between Paediatric and General Surgical Centres in Scotland
An observational study of Appendicitis, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Appendicitis
- How many people
- 4,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2001to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: All children resident in Scotland, who undergo appendicectomy during the study period specified.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
All Scottish NHS Hospitals
All Scottish Surgical Facilities
About this study
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.
Read more
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.
Read the detailed description
The aim of this study is to compare Scottish appendicectomy outcomes in children between specialised paediatric centres versus non-specialised centres.
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 or younger. 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 Disease (ICD)-10 standards and procedures are coded according to the United Kingdom's Office of Population Census Statistics (OPCS) standards, of which the most current 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.
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 1:1. 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 548 was required to demonstrate this difference.
In the last epidemiological study of appendicitis in Scotland (Bisset AF. Appendicectomy in Scotland: a 20-year epidemiological comparison. J Public Health. 1997 Jun 1;19(2):213-8), 1522 appendicectomies in 1993 were performed in children aged 0-15 years old. This suggests that a 10 year cohort should be more than adequate to detect a clinically significant difference in length of stay.
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 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 between Scotland's specialist paediatric centres and general surgical centres.
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.
- Conditions
- Appendicitis
- Keywords
- Outcome Assessment (Health Care), Appendectomy, Child, Hospitals, Pediatric, Hospitals, General
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2001
- Primary completionDec 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewen M Harrison, FRCS, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047786
- Sponsor's protocol ID
- XRB13069-PGA
- Status last verified
- Jan 2014
- First submitted
- 16 Dec 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Appendicectomy Outcomes in Children Between Paediatric and General Surgical Centres in Scotland
- ClinicalTrials.gov ID
- NCT02047786
- Acronym / sponsor ID
- XRB13069-PGA
- Conditions
- Appendicitis
- Keywords
- Outcome Assessment (Health Care), Appendectomy, Child, Hospitals, Pediatric, Hospitals, General
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to compare Scottish appendicectomy outcomes in children between specialised paediatric centres versus non-specialised centres.
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 or younger. 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 Disease (ICD)-10 standards and procedures are coded according to the United Kingdom's Office of Population Census Statistics (OPCS) standards, of which the most current 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.
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 1:1. 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 548 was required to demonstrate this difference.
In the last epidemiological study of appendicitis in Scotland (Bisset AF. Appendicectomy in Scotland: a 20-year epidemiological comparison. J Public Health. 1997 Jun 1;19(2):213-8), 1522 appendicectomies in 1993 were performed in children aged 0-15 years old. This suggests that a 10 year cohort should be more than adequate to detect a clinically significant difference in length of stay.
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 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 between Scotland's specialist paediatric centres and general surgical centres.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children resident in Scotland, who undergo appendicectomy during the study period specified.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative length of stay
Time frame: From date of appendicectomy to date of discharge (whole days) - up to 12.5 years
(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.
Re-operation
Time frame: Within the index admission (censored beyond a maximum of 12.5 years) or within 30 days of discharge
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.
Re-admission
Time frame: Within 30 days of index discharge
Re-admission to any hospital specialty ≤30 days have elapsed since date of discharge.
Mortality
Time frame: Either within 30 days of procedure, or during continuous in-patient stay (up to 12.5 years)
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.
Negative appendicectomy rate
Time frame: At time of index procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewen M Harrison, FRCS, PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative length of stay (time frame: From date of appendicectomy to date of discharge (whole days) - up to 12.5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.