Children, OnlyCASAPNCT04602429
Children's Acute Surgical Abdomen Programme
An observational study of Children, Only and Surgery, run by University College, London at 1 site in United Kingdom.
Trial summary
To describe the type and quality of care being delivered to children (aged 1 - 16 years old) undergoing emergency abdominal surgery in the United Kingdom by measuring baseline compliance against evidence-based recommendations and identifying variations in care between individual hospitals. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Children, Only, Surgery, Abdomen, Acute
- How many people
- 3,100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2019to 31 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1 - 16 years old undergoing emergency abdominal surgery.
Who may be able to join
- Children aged 12 months and 16 years old
- Children 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.
- (Definitions - Unplanned is defined as non-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.)
Who cannot join
- 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
Show all 9Show fewer
- Interventional radiology procedures
- Caesarean sections
- Herniotomies, if the procedure does not involve access to the intra-abdominal cavity.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Children's Hospital
Nottingham, NG7 2UH
About this study
To describe the type and quality of care being delivered to children (aged 1 - 16 years old) undergoing emergency abdominal surgery in the United Kingdom by measuring baseline compliance against evidence-based recommendations and identifying variations in care between individual hospitals.
Read the detailed description
The Children's Acute Surgical Abdomen Programme (CASAP) is a prospective national observational cohort study which aims to characterise the type and quality of care being delivered to children having emergency abdominal surgery.
The investigators aim to recruit every U.K. hospital undertaking this type of surgery in children, and capture information on 5000 patients over the study period.
The data collected will include information on patient risk factors, compliance with process quality indicators and the incidence and type of postoperative complications encountered. The data collected will be used to describe the current epidemiology of this patient group and to develop and internally validate a risk prediction tool for children undergoing emergency abdominal surgery. This tool be used to provide hospitals with their own risk-adjusted outcome measures and can subsequently be used to inform bedside decision-making. Patients will be followed up for 10 years through a data linkage process with National Health Service (NHS) Digital national databases.
- Conditions
- Children, Only, Surgery, Abdomen, Acute, Perioperative Complication
- Medical subject headings
- Abdomen, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing postoperative morbidity.
Defined by the Clavien Dindo grading system:
Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Blood transfusions and total parenteral nutrition are also included. Grade III Requiring surgical, endoscopic or radiological intervention
- IIIa Intervention not under general anesthesia
- IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including Central Nervous System complications)* requiring Intensive Care Unit -management
- IVa single organ dysfunction (including dialysis)
- IVb multiorgan dysfunction Grade V Death of a patient
Measured: 30 days
Secondary outcomes (4)
The length of hospital stay in days
Measured: 30 days
The number of patients who do not survive their in-hospital stay censored at 30 days.
Measured: 30 days
The mortality rate of children undergoing emergency abdominal surgery at 90 days, 1 year and 10 years post procedure date.
Measured: 90 days, 1 year and 10 years.
The readmission rate for children after having emergency abdominal surgery
Measured: 90 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start30 Sep 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602429
- Sponsor's protocol ID
- 18/0342
- Acronym
- CASAP
- Status last verified
- Dec 2024
- First submitted
- 20 Oct 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Acute Surgical Abdomen Programme
- ClinicalTrials.gov ID
- NCT04602429
- Acronym / sponsor ID
- CASAP / 18/0342
- Conditions
- Children, Only, Surgery, Abdomen, Acute, Perioperative Complication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,100 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 26 Oct 2020 (actual)
- 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.
To describe the type and quality of care being delivered to children (aged 1 - 16 years old) undergoing emergency abdominal surgery in the United Kingdom by measuring baseline compliance against evidence-based recommendations and identifying variations in care between individual hospitals.
Detailed description
The Children's Acute Surgical Abdomen Programme (CASAP) is a prospective national observational cohort study which aims to characterise the type and quality of care being delivered to children having emergency abdominal surgery.
The investigators aim to recruit every U.K. hospital undertaking this type of surgery in children, and capture information on 5000 patients over the study period.
The data collected will include information on patient risk factors, compliance with process quality indicators and the incidence and type of postoperative complications encountered. The data collected will be used to describe the current epidemiology of this patient group and to develop and internally validate a risk prediction tool for children undergoing emergency abdominal surgery. This tool be used to provide hospitals with their own risk-adjusted outcome measures and can subsequently be used to inform bedside decision-making. Patients will be followed up for 10 years through a data linkage process with National Health Service (NHS) Digital national databases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1 - 16 years old undergoing emergency abdominal surgery.
Key inclusion criteria (3 listed)
- Children aged 12 months and 16 years old
- Children 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.
- (Definitions - Unplanned is defined as non-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.)
Key exclusion criteria (9 listed)
- 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
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
Number of patients experiencing postoperative morbidity.
Time frame: 30 days
Defined by the Clavien Dindo grading system: Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Intervention not under general anesthesia * IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including Central Nervous System complications)* requiring Intensive Care Unit -management * IVa single organ dysfunction (including dialysis) * IVb multiorgan dysfunction Grade V Death of a patient
4 secondary outcomes
The length of hospital stay in days
Time frame: 30 days
The number of patients who do not survive their in-hospital stay censored at 30 days.
Time frame: 30 days
The mortality rate of children undergoing emergency abdominal surgery at 90 days, 1 year and 10 years post procedure date.
Time frame: 90 days, 1 year and 10 years.
The readmission rate for children after having emergency abdominal surgery
Time frame: 90 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
Related trials for Children, Only
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Recruiting
Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children
Procedural Pain, Pain-related Fear
RecruitingPhase 2
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Colitis, Ulcerative
Recruiting
HABIT-ILE + FST in Children With SMA: Preliminary Effectiveness
Spinal Muscular Atrophy (SMA)
Enrolling by invitation
Exercise as Medicine for Pediatric Chronic Pain
Chronic Pain, Child
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Children, Only and Surgery, run by University College, London 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients experiencing postoperative morbidity. (time frame: 30 days). 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 16 Dec 2024.