Children's Acute Surgical Abdomen Programme (CASAP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Children, Only; Abdomen, Acute; Perioperative Complication

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 Type: Observational
• Enrollment (Actual): 3100

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 - 16 years old undergoing emergency abdominal surgery.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The length of hospital stay in days	30 days
The number of patients who do not survive their in-hospital stay censored at 30 days.	30 days
The mortality rate of children undergoing emergency abdominal surgery at 90 days, 1 year and 10 years post procedure date.	90 days, 1 year and 10 years.
The readmission rate for children after having emergency abdominal surgery	90 days and 1 year

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: National Institute for Health Research, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): January 31, 2022
• Study Completion (Estimated): January 31, 2032

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Abdomen, Acute
• Other Study ID Numbers: 18/0342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No