Children's Acute Surgical Abdomen Programme
Conditions: Children, Only, Surgery, Abdomen, Acute, Perioperative Complication
Sponsor: University College, London

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CASAP Patient Study Protocol, IRAS: 234524,  (version 1.2 11/09/2019) 
 
STUDY TITLE 
 
Children’s Acute Surgical Abdomen Programme 
 
SHORT STUDY TITLE  
CASAP 
 
 
Chief Investigator: 
Prof. Ramani Moonesinghe 
Professor of Perioperative Medicine, University College London 
Honorary Consultant in Anaesthesia and Perioperative Medicine, UCLH 
Director, National Institute for Academic Anaesthesia’s Health Services Research Centre 
Royal College of Anaesthetists, Churchill House, London 
ramani.moonesinghe@nhs.net 
 
Sponsored by: 
University College London (UCL) 
 
Protocol version number and date: 1.2 (11.09.2019) 
 
 
R&D / Sponsor Reference Number(s): 18/0342 
 
Study Registration Number: 
 
 
 
 
 

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PROTOCOL VERSIONS 
Version Stage 
Versions No 
Version Date 
Protocol updated & 
finalised by; 
Appendix 
No 
detail 
the 
reason(s) for the protocol 
update 
 
1.2 
11/09/2019 
L. A. Sogbodjor 
Inclusion/Exclusion 
Criteria 
amended to provide more 
clarity (pages 14 and 15) 
 
Minor changes to contact 
details of study team 
 
1.1 
21/05/2019 
Prof 
S.R. 
Moonesinghe 
Response to initial ethics 
committee review: change 
from 
consenting 
to 
non-
consenting model 
Pre-study 
draft for ethics 
1.0 
14/05/2018 
L. A. Sogbodjor 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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DECLARATIONS 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the Research Governance Framework 2005 (as amended thereafter), the Trust Data & Information 
policy, Sponsor and other relevant SOPs and applicable Trust policies and legal frameworks. 
I (investigator) agree to ensure that the confidential information contained in this document will not 
be used for any other purposes other than the evaluation or conduct of the clinical investigation 
without the prior written consent of the Sponsor. 
I (investigator) also confirm that an honest accurate and transparent account of the study will be given; 
and that any deviations from the study as planned in this protocol will be explained and reported 
accordingly. 
Chief Investigator: 
Signature:........................ 
.............................      Date….11/09/2019 
Print Name(in full): Prof Ramani Moonesinghe.............. 
Position: Professor of Perioperative Medicine, UCL 
 
On behalf of the Study Sponsor: 
Signature: 
        Date 16/09/2019 
Print Name(in full): Pushpsen Joshi 
Position: Research Management and Governance Manager 
 
 
 

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STUDY SUMMARY 
Identifiers 
 
IRAS Number 
234524 
REC Reference No 
19/LO/0267  
Sponsor Reference No 
18/034 
Other research reference 
number(s) (if applicable) 
 
 
 
Full (Scientific) title 
Children’s Acute Surgical Abdomen Programme  
Health 
condition(s) 
or 
problem(s) studied 
Perioperative Medicine, Paediatric Surgery, Anaesthesia 
Study Type i.e. Cohort etc 
Prospective Observational Cohort Study 
Target sample size 
5000 
 
 
STUDY TIMELINES 
 
Study Duration/length 
10 years and 6 months 
Expected Start Date 
Jul 2019 
End of Study definition and 
anticipated date 
Dec 2029: Following completion of 10 year mortality follow up 
obtained via data-linkage with NHS Digital / Office of National 
Statistics mortality database. 
 
Key Study milestones  
 
 
FUNDING & Other 
 
Funding  
National Institute of Academic Anaesthesia (APAGBI Project Grant) 
£40,000 
Other support  
Health Services Research Centre  
Email: CASAP@rcoa.ac.uk 
Address: The Royal College of Anaesthetists, Churchill House, 35 Red 
Lion Square, London WC1R 4SG 

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STORAGE of SAMPLES  
(if applicable) 
 
KEY STUDY CONTACTS 
Full contact details including phone, email and fax numbers 
Chief Investigator  
Prof S.Ramani Moonesinghe  
Email: ramani.moonesinghe@nhs.net 
Telephone: 07956620717 
Address: UCL/UCLH Surgical Outcomes Research Centre, Centre for 
Perioperative Medicine, UCL Division of Surgery and Interventional 
Science, Charles Bell House, 43-47 Foley Street, London W1W 7TS 
Co-Investigator 
LA Sogbodjor 
Email: a.sogbodjor@ucl.ac.uk 
Telephone: 07930472625 
Address: Health Services Research Centre, The Royal College of 
Anaesthetists, Churchill House, Red Lion Square, London, WC1R 4SG 
Study Coordinators 
Karen Williams and Laura Farmer 
Health Services Research Centre  
Email: CASAP@rcoa.ac.uk 
Address: The Royal College of Anaesthetists, Churchill House, 35 Red 
Lion Square, London WC1R 4SG 
 
 
KEY ROLES AND RESPONSIBILITIES 
SPONSOR: The sponsor is responsible for ensuring before a study begins that arrangements are in 
place for the research team to access resources and support to deliver the research as proposed and 
allocate responsibilities for the management, monitoring and reporting of the research. The Sponsor 
also has to be satisfied there is agreement on appropriate arrangements to record, report and review 
significant developments as the research proceeds, and approve any modifications to the design.  
 
FUNDER: The funder is the entity that will provide the funds (financial support) for the conduction of 
the study. Funders are expected to provide assistance to any enquiry, audit or investigation related to 
the funded work.  
 

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CHIEF INVESTIGATOR (CI): The person who takes overall responsibility for the design, conduct and 
reporting of a study. If the study involves researchers at more than once site, the CI takes on the 
primary responsibility whether or not he/she is an investigator at any particular site. 
 
The CI role is to complete and to ensure that all relevant regulatory approvals are in place before the 
study begins. Ensure arrangements are in place for good study conduct, robust monitoring and 
reporting, including prompt reporting of incidents, this includes putting in place adequate training for 
study staff to conduct the study as per the protocol and relevant standards. 
 
The Chief Investigator is responsible for submission of annual reports as required. The Chief 
Investigator will notify the RE of the end of the study, including the reasons for the premature 
termination. Within one year after the end of study, the Chief Investigator will submit a final report 
with the results, including any publications/abstracts to the REC.  
 
STUDY COORDINATOR: Responsible for day to day project management and general queries. 
 
PRINCIPLE INVESTIGATOR (PI):  Individually or as leader of the researchers at a site; ensuring that 
the study is conducted as per the approved study protocol, and report/notify the relevant parties – 
this includes the CI of any breaches or incidents related to the study. 
 
 

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KEY WORDS 
Anaesthesia; Paediatrics; Perioperative Medicine; Surgery 
 
LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
AR 
CASAP 
Adverse Reaction 
Children’s Acute Surgical Abdomen Programme  
CI 
Chief Investigator 
CRF 
Case Report Form 
CRO 
Contract Research Organisation 
DMC 
Data Monitoring Committee 
GAfREC 
HSRC 
Governance Arrangement for NHS Research Ethics 
Health Services Research Centre 
IB 
Investigator Brochure 
ICF 
NIAA 
NIHR 
PID 
Informed Consent Form 
National Institute for Academic Anaesthesia 
National Institute for Health Research 
Patient Identifiable Data 
PI 
Principle Investigator 
PIS 
QA 
QI 
RCoA 
Participant Information Sheet 
Quality Assurance 
Quality Improvement 
Royal College of Anaesthetists 
REC 
Research Ethics committee 
SAR 
Serious Adverse Reaction 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification 
SOP 
Standard Operating Procedure 
SSI 
Site Specific Information 
TMF 
Trial Master File 
 
 

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CONTENTS 
1 
INTRODUCTION .................................................................................................................................................... 9 
2 
BACKGROUND AND RATIONALE .................................................................................................................. 9 
3 
AIMS and OBJECTIVES .................................................................................................................................... 11 
3.1 
Aims .................................................................................................................................................................. 11 
3.2 
Research Questions ................................................................................................................................... 11 
3.3 
Objectives....................................................................................................................................................... 11 
3.3.1 
Research: .................................................................................................................................................. 11 
3.3.2 
Feasibility for longer term national quality improvement programme: ...................... 12 
4 
STUDY DESIGN ................................................................................................................................................... 12 
5 
STUDY SCHEDULE ............................................................................................................................................ 12 
5.1 Enrolment process ......................................................................................................................................... 12 
5.2 Data collection and data linkage .............................................................................................................. 12 
5.3 Participant Withdrawal ............................................................................................................................... 13 
5.4 Study Closure ................................................................................................................................................... 13 
5.5 Study Management ........................................................................................................................................ 13 
6 
CONSENT .............................................................................................................................................................. 14 
7 
ELIGIBILITY CRITERIA ................................................................................................................................... 14 
7.1 
Hospital Level .............................................................................................................................................. 14 
7.2 
Patient Level ................................................................................................................................................. 14 
8 
RECRUITMENT................................................................................................................................................... 15 
9 
STATISTICAL METHODS ................................................................................................................................ 15 
10 
PATIENT AND PUBLIC INVOLVEMENT (PPI) ...................................................................................... 17 
11 
FUNDING AND SUPPLY OF EQUIPMENT ................................................................................................ 17 
12 
DATA HANDLING AND MANAGEMENT .................................................................................................. 18 
12.1 Patient level data ......................................................................................................................................... 18 
13 
PEER AND REGULATORY REVIEW ........................................................................................................... 21 
14 
ASSESMENT AND MANAGEMENT OF RISK ........................................................................................... 21 
15 
INDEMNITY ARRANGEMENTS.................................................................................................................... 21 
16 
ARCHIVING .......................................................................................................................................................... 21 
17 
PUBLICATION AND DISSEMINATION POLICY ..................................................................................... 22 
18 
Participating NHS Trusts and Health Boards........................................................................................ 22 
19 
REFERENCES ...................................................................................................................................................... 22 
20 
APPENDICES ....................................................................................................................................................... 24 
 

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1 INTRODUCTION 
 
CASAP will review the type and quality of care provided to children undergoing emergency 
abdominal surgery in the United Kingdom. In doing so it will measure baseline compliance against 
evidence-based recommendations and identify variations in care between individual hospitals. 
This study will test the feasibility of gathering and analysing such data with a view to establishing 
a longer term national quality improvement programme for this high-risk patient group. An 
additional aim of this study is to develop a risk-adjustment model for children having this kind of 
surgery.  
 
CASAP is a prospective observational cohort study. Data will be collected on all patients (aged 1 - 
16 years on the day of surgery) undergoing unplanned abdominal surgery in the UK until we 
reach our target recruitment of 5000 patients. We will measure postoperative morbidity during 
the inpatient stay and will establish longer term outcomes in these children by linking 
prospectively collected in-hospital data and longer-term hospital episode statistics and mortality 
data held by NHS Digital.  
 
CASAP will be led by a UCL-employed Chief Investigator working with the Health Services 
Research Centre, of which the CI is the director, based at the Royal College of Anaesthetists. The 
management of the study will be supported by a steering group comprised of key stakeholder 
representatives including paediatric intensivists, surgeons, anaesthetists, and members of the 
public. 
 
2 BACKGROUND AND RATIONALE 
 
There is a recognised gap in the quality of care delivered to elective and emergency surgical 
patients: this has been highlighted as a priority for health services research by patients and 
clinicians.(1) The care provided to adults undergoing emergency abdominal surgery has been 
the focus of a comprehensive national effort to quality assure clinical practice, identify variation 
between institutions and in so doing, improve patient outcomes. The National Emergency 
Laparotomy Audit (NELA; www.nela.org.uk ) was established in 2011 to audit against national 
recommendations for the care of adult patients undergoing emergency abdominal surgery, and 

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continues to date, having collected data on over 90,000 patients in 183 hospitals in England and 
Wales.(2–6) Bolt-on local quality improvement (QI) initiatives which have used NELA data to 
implement changes in practice have been associated with significant reductions in adverse 
outcomes.(7) Deficiencies in the quality of emergency surgical care provided to children were 
highlighted in a NCEPOD report in 2011 and more recent evidence suggests that whilst there 
has been a reduction in the number of some emergency procedures undertaken, this has been 
accompanied by an increase in the overall incidence of adverse outcomes.(8,9) As a result, 
paediatric emergency general surgery has been identified by the Association of Paediatric 
Anaesthetists and the British Association of Paediatric Surgeons as a priority area for quality 
assurance and quality improvement, but until now, there has been no consolidated national 
effort to measure or report processes and outcomes in this patient group.  
Any initiative which aims to measure quality (with the aim of improvement) in paediatric 
emergency abdominal surgery will need to achieve several goals. First, the metrics used should 
be comprehensive, appropriate for this patient group and based on evidence or 
national/international recommendations. The measurement of quality can be divided into 
structure, process and outcome indicators according the criteria established by 
Donabedian.(10) The structures and processes which influence outcome in a paediatric cohort 
of patients undergoing emergency abdominal surgery are sufficiently different from adult 
surgery that the direct mapping of adult audit, QA or QI initiatives to children’s perioperative 
care is likely to be of limited value. For example, the centralisation of paediatric surgical 
services has resulted in increased referral rates of emergency patients to specialist centres and 
a subsequent increase in demand for inter-hospital transfers,(8) which are not generally 
required in adult emergency abdominal surgery. Second, the outcomes assessed also require 
tailoring to this population, and need to be feasible and valid for use in a pragmatic multi-centre 
evaluation without specialist training of staff. Measures traditionally used in adult perioperative 
health-services research such as inpatient or 30-day mortality are not appropriate as the sole 
outcomes of interest in this population, as short-term mortality is so uncommon in children 
having this type of surgery. Instead, measures such as postoperative morbidity and the 
requirement for longer-term nutritional supplementation are likely to be more meaningful for 
both patients and clinicians. Finally, engagement from several specialities is needed to capture 
all aspects of such a pathway. This includes paediatricians and intensivists as well as both 
general and specialist paediatric surgeons and anaesthetists.  
 

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3 AIMS and OBJECTIVES 
3.1 Aims 
 
1. To measure compliance against process measures which have been recommended for 
the delivery of clinical care to children undergoing emergency abdominal surgery in 
the U.K. 
 
2. To develop and internally validate a risk prediction/adjustment tool for paediatric 
emergency abdominal surgery using a comprehensive paediatric U.K. sample. 
 
 
3. To determine the feasibility of a longer term national QI programme in this patient 
group 
 
3.2 Research Questions 
 
1. What is the level of compliance with national and international recommendations for 
processes relevant to the care of children undergoing emergency abdominal surgery 
in the U.K.?  
 
2. What are the independent risk factors for adverse postoperative outcomes in 
paediatric patients undergoing emergency abdominal surgery? 
 
3.3 Objectives 
 
3.3.1 
Research: 
• 
To collect quality and outcome data on paediatric patients whose parents have provided 
informed consent, undergoing emergency abdominal surgery in all UK hospitals   

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• 
To measure and analyse patient-level estimates of perioperative risk using previously 
identified risk factors, to develop and internally validate a risk-prediction model for 
children’s emergency abdominal surgery  
 
3.3.2 
Feasibility for longer term national quality improvement programme: 
• 
To test the feasibility (screening to recruitment ratio) of a consenting model for 
collecting this type of quality data in paediatric patients undergoing emergency 
abdominal surgery 
• 
To test the feasibility of data linkage for paediatric patients between prospectively 
collected in-hospital data and longer-term hospital episode statistics and mortality data 
held by NHS Digital (England), the Patient Episode Database for Wales (PEDW) and the 
NHS Central Register (Scotland)  
 
4 STUDY DESIGN 
Prospective observational cohort study  
 
5 STUDY SCHEDULE 
5.1 Enrolment process 
Screening for patients who meet the inclusion criteria will be conducted on a daily basis by local 
researchers, through locally determined processes but which are likely to include screening of 
emergency operating theatre lists and ward occupancy lists. Once identified, parents/legal 
guardians and children will be provided with participant information sheets informing them of 
the study and they will be given at least one hour to consider the information before parents are 
approached to provide consent. 
 
5.2 Data collection and data linkage 
There are two points of data collection during the inpatient stay (Case Report Form parts 1 and 
2) 
- 
Part 1: data about preoperative status and intraoperative care – to be completed as soon 
as possible during or after surgery 

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- 
Part 2: postoperative follow-up data – to be completed either on discharge from hospital 
or at 30 days postoperatively, whichever occurs first.  This CRF requires information 
about the patient’s post-operative journey which will be routinely documented in the 
notes (such as the ongoing use of pain medication). The Clavien-Dindo classification 
system will be used to grade the severity of postoperative complications 
encountered.(11) 
 
Inpatient stay will be censored at 30 days post-surgery. Therefore, the final entry in the CRF will 
be whichever of the following three options is the chronologically earliest date: date of 
discharge from hospital, date of death while in hospital, or 30 days’ post-surgery if the patient 
remains in hospital on that date. 
Prospectively collected patient data will be linked to NHS Digital's mortality data using the 
Bespoke Data Linkage service. We will specifically aim to establish survival at 30 days, 90 days, 
and 1 year as well as longer term survival (up to 10 years). Follow up at 10 years will represent 
the last study activity for each individual participant.  
 
5.3 Participant Withdrawal 
Participants will be able to withdraw their participation by notifying the local teams.  
 
5.4 Study Closure 
Study recruitment will end after 5000 children have been recruited. Follow up at 10 years will 
represent the last study activity for each individual participant and CRFs will be destroyed 10 
years after the last study activity. 
 
5.5 Study Management 
The project team is chaired by the Chief Investigator and will meet monthly to deliver the day-
to-day organization of the study. This team includes a student researcher who has collated the 
quality metrics for the dataset through conducting a systematic review of structures and 
processes measures, and who will be involved in the data analysis and reporting of the study 
findings. A study steering committee with an independent chair (Professor Mark Peters, 
Paediatric Intensive Care Consultant at Great Ormond Street Hospital) will meet bi-annually and 

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advise on study design and conduct; this consists of multi-disciplinary, professional and lay 
representation.  
 
6 CONSENT 
The parents of children aged between 1 year and 16 years on the planned or actual date of 
surgery will be approached to provide informed consent to participate. Patients will first be 
identified by research nurses or by clinical nurses, emergency medicine doctors, critical care 
specialists, anaesthetists and/or surgeons involved in their care. Potential participants will be 
provided with a participant information sheet (one for the parent/legal guardian and, where 
appropriate, one for the child aged 10 - 15 years old). They will be given at least one hour to 
consider the information provided before the adult is approached for informed consent. All 
participating hospitals will be provided with posters explaining that the study is ongoing which 
should be displayed in public areas (e.g. emergency departments, wards, operating theatre 
waiting rooms)  
 
As this study involves only the collection of data which is part of routine clinical care, 
distribution of participant information sheets and approach for consent can take place at any 
point between time that the decision for surgery is made (the earliest point of approach) and 
the patient’s discharge from hospital after surgery – however, local research teams are 
encouraged to approach patients/carers as early as possible. 
7 ELIGIBILITY CRITERIA 
7.1 Hospital Level 
All NHS hospitals which provide care to children who may require emergency abdominal 
surgery will be eligible to take part.  
7.2 Patient Level 
Inclusion Criteria: 
 
Children between 12 months and 16 years of age undergoing unplanned abdominal surgery, 
where the preoperative diagnosis was considered to be related to a non-traumatic bowel 
(including appendix), hepatobiliary, and/or splenic pathology. Unplanned is defined as non-

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elective (i.e. the patient presented requiring emergency or urgent intervention, either as a 
primary presentation or as a complication of previous surgery). Surgery is defined as a 
procedure undertaken by a surgeon in an operating theatre requiring the support of an 
anaesthetist. Any surgical approach (e.g. open, laparoscopic, robotic assisted etc) is 
acceptable.   
 
Exclusion Criteria: 
 
Patients / parents who do not provide consent. Children <12 months old on day of surgery, 
elective procedures, operations where the preoperative indication for surgery was considered 
to be traumatic, urological or gynaecological in origin, organ transplants, insertion/removal of 
dialysis catheters,  interventional radiology procedures and Caesarean sections. Herniotomies 
are also excluded if the procedure does not involve access to the intra-abdominal cavity. 
 
8 RECRUITMENT 
8.1 Hospital recruitment 
Hospitals will be recruited using the NIAA HSRC’s Quality Audit and Research Coordinator 
(QuARC) network, aiming for 100% coverage across the UK.  
8.2 Participant recruitment  
All patients who meet our inclusion criteria in participating hospitals will be approached for 
participation. A screening log will be kept at local level to enable us to ascertain the 
feasibility of recruiting paediatric patients having emergency surgery.  
9 STATISTICAL METHODS 
9.1 Analysis plan  
Assessment of feasibility  
The main assessment of feasibility will be screening to recruitment ratios. The second 
assessment will be quality of data linkage between our prospective dataset and nationally held 
registries of processes and outcomes.  

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Descriptive and inferential analysis  
Prospectively collected data 
Our primary outcome will be postoperative complications measured using the Clavien-Dindo 
grading system. Secondary outcome measures will include: type of complication (e.g. 
pulmonary, infectious), length of hospital stay, inpatient mortality.   
Data linkage 
Through subsequent data linkage we will ascertain at 30 days, 90 days and 1 year; longer term 
survival (up to 10 years) and hospital readmission. 
Logistic regression will determine independent predictors for our primary and secondary 
outcomes, including both patient risk factors and structure / process level indicators with 
attention being paid to the hierarchical structure of the data (patients nested within hospitals). 
We will use multivariable regression with bootstrapping to develop and internally validate a 
risk prediction model to predict short-term morbidity. The purpose of this analysis is to develop 
models which can be used as a basis for risk adjustment in a future longer-term study, and to 
remove unnecessarily measured variables.  
Sample size calculation  
As this is an observational pilot study we are not including a formal sample size calculation. 
However, we will aim to recruit 5000 patients to enable sufficiently large cohort to achieve our 
goals of being able to develop a risk adjustment model and validate the outcome measures. We 
have also considered likely recruitment rates when determining the duration of this pilot phase. 
A previous study (12) recruited 703 patients undergoing emergency appendectomy over 2 
months in 98 U.K. hospitals. Previous audits of emergency laparotomy in large children’s 
hospitals have indicated that approximately one emergency laparotomy is undertaken per 
week. A previous study collected data from children of all ages undergoing anaesthesia in the 
UK and Europe.(13) 31,127 cases were recruited across Europe of which 5893 (18.9%) were 
emergency cases, and 1475 (4.73%) were emergency or urgent abdominal surgery. 
Extrapolating this incidence to UK data based on Hospital Episode Statistics, which shows that 
565,373 children within our inclusion ages underwent surgery in the year 2015-16, we estimate 
that the annual number of emergency abdominal procedures which would fit our criteria in 
England alone would be 26,742. Therefore in 3 months in England alone we would hope to 
capture information on approximately 6500 children. Based on these data, we estimate that 

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approximately 5000 children will be recruited to the study over a 3 month period from across 
the 4 devolved nations. We aim to recruit 5000 children and the study will continue to run until 
this target has been met. This is important to be able to estimate the feasibility of recruitment, 
avoidance of sampling bias and to be able to demonstrate sustainability of recruitment with a 
view to a longer-term programme.  
9.2 Additional analyses and data sharing  
Once the primary analysis of the CASAP dataset is complete, requests for anonymised datasets 
from investigators outside the core study team and steering group with the purpose of 
conducting secondary analyses will be considered. This will entail formal review of such 
requests by both the study project team and the steering committee. If the request comes in 
after these structures have been disbanded, the responsibility for reviewing such requests will 
rest with the Chief Investigator.   
 
10 PATIENT AND PUBLIC INVOLVEMENT (PPI) 
We have sought patient and public involvement from the NIAA Health Services Research Centre 
PCPIE group and the NIHR Young Persons Advisory Group in the West Midlands. Both groups 
have kindly reviewed our protocol and our patient information leaflets. A representative from 
the YPAG, Ms Mohini Samani, has also joined the study steering committee. 
 
11 FUNDING AND SUPPLY OF EQUIPMENT  
The study funding has been reviewed by the UCL Research Office, and deemed sufficient to cover 
the requirements of the study. NHS costs will be supported via UCLH and/or the Local Clinical 
Research Network.  
 
The research costs for the study have been supported by the National Institute for Academic 
Anaesthesia (APAGBI Project grant). 
 
Insurance for all participating sites will be provided through NHS Indemnity. 

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12 DATA HANDLING AND MANAGEMENT 
12.1 Patient level data 
All investigators and study site staff will comply with the requirements of the Data Protection 
Act 1998 with regards to the collection, storage, processing and disclosure of personal 
information and will uphold the Act’s core principles.  
Data will be collected on all patients who meet the inclusion criteria and whose parent/legal 
guardian provides consent. Each hospital taking part will have nominated staff who will be 
responsible for data collection and postoperative follow up.  
Completed questionnaires will be taken directly to a secure location accessible only by the local 
PI and other named members of the study team. On Day 30 postoperatively, local investigators 
will check the patient status (remains inpatient, vs. discharged from hospital, vs. died). The 
occurrence of postoperative complications will be determined through review of the patient 
record (medical notes, nursing charts and clinical / laboratory investigations). If the patient has 
been discharged from hospital or has died, this will be recorded on the CRF.  
Inpatient stay will be censored at 30 days post-surgery. Therefore, the final entry in the CRF will 
be whichever of the following three options is the chronologically earliest date: date of 
discharge from hospital, date of death while in hospital, or 30 days post-surgery if the patient 
remains in hospital on that date. 
 
12.3 Data handling and record keeping 
 
At individual hospital level, the completed CRFs will be held in a secure location accessible only 
by the local PI and other named members of the study team in accordance with GCP guidelines 
and local information and research governance frameworks. Information from the paper CRF 
will be entered via a secure web-based portal onto the study database. The uploading of data 
will occur in two steps. Firstly, a pseudonymised dataset with name, DoB, and date of surgery 
replaced by a unique CASAP Study ID, age and day of week on which surgery occurred will be 
uploaded onto the study database via UCL’s Non-Data Safe Haven REDCAP web-based portal. 
This will be hosted on UCL servers. Local investigators will have access to enter and edit data 
from their own hospital. Secondly, a partial dataset containing the patient identifiers required 
for data linkage with NHS Digital will be uploaded by local investigators onto UCL’s Data Safe 

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Haven using a secure file transfer portal. Only the core CASAP study team will have access to 
this data. Functionality of the CRFs and study database will be piloted in two hospitals in 
England prior to the start date of the study. 
For the purposes of data linkage with NHS Digital the minimum amount of patient identifiable 
data will be extracted from the database on the UCL Data Safe Haven by the central investigation 
team, onto a password protected Excel spreadsheet. This will be emailed securely NHS Digital, 
to facilitate linkage to centrally held mortality data. Mortality will be tracked for all patients 
with a final censure date of 10 years after participant recruitment. Please see Data Flow 
Diagram for illustration (Figure1). 
 
Figure 1: CASAP Data Flow Diagram 
 
Patient identifiable data will be used to ensure individual patient records within the CASAP 
system are managed correctly, keeping distinct treatment episodes linked to the correct patient 
and will enable data linkage with the NHS Digital mortality tracking system. Four patient 
identifiers will be used: patient name, date of birth, NHS number and postcode.  

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The NHS number is not completely populated in the NHS Digital system and the other patient 
identifiers are used when the NHS number is absent.  In addition, by using these four identifiers 
in combination, possible erroneous record linkages are flagged.   
The following paragraphs describe the process of linkage to the NHS Digital mortality tracking 
system. The same process will be applied for linkage to HES data.   
A file (P) containing patient identifiers only will be extracted from the full dataset hosted in the 
webtool, and will be sent securely to a trusted Data Linkage Service.  For both mortality tracking 
data and HES data, this will be NHS Digital.  File (P) will contain the following identifiers: 
• 
CASAP anonymised identifier  
• 
NHS number 
• 
Date of Birth 
• 
Sex 
• 
Postcode 
For each patient in the file, NHS Digital will identify the matching ONS ID.  NHS Digital will 
return to UCL a ‘look-up’ file (L) containing only the CASAP identifier and the HESID identifiers, 
and a MATCH_RANK field which indicates the strength of the match.   
An extract of anonymised ONS mortality data will then be requested from NHS Digital for all the 
list of ONS IDs contained in file (L). 
The file (L) will be placed in the secure UCL server accessible only to the project data manager.  
It will then be used to link the anonymised ONS data to the anonymised CASAP data for analysis.   
 
The electronic patient datasets will be appropriately sent to Prof Ramani Moonesinghe for 
statistical analysis. Prof Moonesinghe will also act as the data custodian for the data collected as 
part of the CASAP study. UCL will process, store and dispose of all participant datasets in 
accordance with all applicable legal and regulatory requirements, including the Data Protection 
Act 1998 and any amendments thereto. 
An anonymised dataset will be used by the central CASAP study team, led by Prof Ramani 
Moonesinghe, for analysis. In this dataset, the NHS number will be replaced by a unique study 
number, date of birth will be converted to ‘Age at time of surgery’ and postcode will be 
converted to PCT, SHA of residence and the Office for National Statistics Lower Super Output 
Area, which allows the allocation of the Index of Multiple Deprivation.  Sex will be the only 
patient identifier used in the analysis. Some of the results of this study will be included in an 
academic project conducted by a member of the CASAP study team as part of a higher degree at 
UCL . Only anonymised data will be analysed. No patient identifiable data will be accessed. 

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13 PEER AND REGULATORY REVIEW 
The study has been peer reviewed in accordance with the requirements outlined by UCL. 
 
• 
The Sponsor considers the procedure for obtaining funding from the National Institute for 
Academic Anaesthesia to be of sufficient rigour and independence to be considered an 
adequate peer review. 
14 ASSESMENT AND MANAGEMENT OF RISK 
We do not consider this observational study to carry any significant risks to participants or 
investigators. 
15 INDEMNITY ARRANGEMENTS 
 
University College London holds insurance against claims from participants for harm caused by their 
participation in this clinical study. Participants may be able to claim compensation if they can prove 
that UCL has been negligent. However, if this clinical study is being carried out in a hospital, the 
hospital continues to have a duty of care to the participant of the clinical study. University College 
London does not accept liability for any breach in the hospital’s duty of care, or any negligence on the 
part of hospital employees. This applies whether the hospital is an NHS Trust or otherwise. 
16 ARCHIVING 
 
UCL and each participating site recognise that there is an obligation to archive study-related 
documents at the end of the study (as such end is defined within this protocol). The Chief Investigator 
confirms that she will archive the study master file at UCL for the period stipulated in the protocol and 
in line with all relevant legal and statutory requirements. The Principal Investigator at each 
participating site agrees to archive his/her respective site’s study documents for 5 years and in line 
with all relevant legal and statutory requirements. 

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17 PUBLICATION AND DISSEMINATION POLICY 
We intend to present the results online via the study website, in peer reviewed scientific 
journals and in the form of conference presentations. In addition to academic publications we 
will provide specific summary reports for the following groups: 
Healthcare policy makers – this will include medical and nursing Royal Colleges, specialist 
societies, Department of Health, NHS England, NHS Wales, NHS Scotland and Health and Social 
Care Ireland.  
Patients and the Public – our lay representative and the lay representative group at the Royal 
College of Anaesthetists will provide support in our dissemination to the non-medical audience. 
 
18 Participating NHS Trusts and Health Boards   
 
All NHS hospitals which provide care to children who may require emergency abdominal 
surgery will be eligible to take part. This includes those hospitals who may not perform 
such surgery themselves but will admit patients (either for planned care or via an 
emergency department) prior to transfer to a designated paediatric surgical centre. 
19 REFERENCES 
 
1.  
Boney O, Bell M, Bell N, Conquest A, Cumbers M, Drake S, et al. Identifying research 
priorities in anaesthesia and perioperative care: Final report of the joint National 
Institute of Academic Anaesthesia/James Lind Alliance Research Priority Setting 
Partnership. BMJ Open. 2015;5(12):1–10.  
2.  
NELA Project Team. Organisational Report of the National Emergency Laparotomy Audit. 
2014. 1–90 p.  
3.  
NELA Project Team. First patient report of the National Emergency Laparotomy Audit. 
2015.  
4.  
NELA Project Team. The second patient report of the National Emergency Laparotomy 
Audit. 2016;(November 2015):1–160.  

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5.  
Laparotomy E, Nela A. Third Patient Report of the National The third Patient Report of 
the National Emergency Laparotomy Audit ( NELA ) December 2015 to November 2016. 
2017;(October).  
6.  
NELA Project Team. Fourth Patient Report of the National Emergency Laparotomy Audit 
(NELA). 2017;(December 2016).  
7.  
Huddart S, Peden CJ, Swart M, McCormick B, Dickinson M, Mohammed MA, et al. Use of a 
pathway quality improvement care bundle to reduce mortality after emergency 
laparotomy. Br J Surg. 2015;102(1):57–66.  
8.  
Mason D, Wilkinson K, Gough M, Lucas S, Freeth H, Shotton H, et al. Are We There Yet? A 
review of organisational and clinical aspects of children’s surgery. 2011;  
9.  
Giuliani S, Cecil E V., Apelt N, Sharland M, Saxena S. Pediatric Emergency Appendectomy 
and 30-Day Postoperative Outcomes in District General Hospitals and Specialist Pediatric 
Surgical Centers in England, April 2001 to March 2012. Ann Surg [Internet]. 
2016;263:184–90.  
10.  
Donabedian A. Evaluating the quality of medical care. Milbank Q. 1966;44(No. 3, Pt. 
2):166–203.  
11.  
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: A new 
proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 
2004;240(2):205–13.  
12.  
Collaborative NSR. Multicentre observational study of performance variation in provision 
and outcome of emergency appendicectomy. Bhangu A Torrance A, Pinkney T, Battersby 
C, Beral D, Cornish J, Dent H, Hall N, Palser T, Panagiotopoulou I, Strong S, Velineni R, 
Panagiotopoulou I, Chatzizacharias N, Rana M, Rollins K, Ejtehadi F, Jha B, Tan Y, Fanous 
N, Markides G, Tan A, Marshal C, RC, editor. Br J Surg [Internet]. 2013;100(9):1240–52.  
13.  
Habre W, Disma N, Virag K, Becke K, Hansen TG, Jöhr M, et al. Incidence of severe critical 
events in paediatric anaesthesia (APRICOT): a prospective multicentre observational 
study in 261 hospitals in Europe. Lancet Respir Med. 2017;5(5):412–25.  
 

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20 APPENDICES 
1. 
Case Report Form 
2. 
Participant Information Leaflets 
3. 
Data Flow Diagram