Clinical trial NCT04602429: Children's Acute Surgical Abdomen Programme
Official title: Children's Acute Surgical Abdomen Programme
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Children, Only
Surgery
Abdomen, Acute
Perioperative Complication
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2020-10-26
Enrollment: 3100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1 - 16 years old undergoing emergency abdominal surgery.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.)

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
* Caesarean sections
* Herniotomies, if the procedure does not involve access to the intra-abdominal cavity.

Primary outcomes:
measure: Number of patients experiencing postoperative morbidity.
timeFrame: 30 days
Secondary outcomes:
measure: The length of hospital stay in days
timeFrame: 30 days
measure: The number of patients who do not survive their in-hospital stay censored at 30 days.
timeFrame: 30 days
measure: The mortality rate of children undergoing emergency abdominal surgery at 90 days, 1 year and 10 years post procedure date.
timeFrame: 90 days, 1 year and 10 years.
measure: The readmission rate for children after having emergency abdominal surgery
timeFrame: 90 days and 1 year
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Children's Hospital
Study officials:
References: