Children's Acute Surgical Abdomen Programme

Surgery Clinical Trial

— CASAP  

Official title:

Children's Acute Surgical Abdomen Programme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602429
• Other study ID #: 18/0342
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: January 2031

Study information

• Verified date: October 2020
• Source: University College, London
• Contact: Ramani Moonesinghe
• Phone: 02070921577
• Email: CASAP[@]rcoa.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

We 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 NHS Digital national databases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2031
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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-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.

Related Conditions & MeSH terms

• Abdomen, Acute
• Children, Only
• Perioperative Complication
• Surgery

Locations

Country	Name	City	State
United Kingdom	Nottingham Children's Hospital	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Morbidity	Postoperative morbidity defined by the Clavien Dindo grading system.	30 days
Secondary	Type of Complication	Categorised according to the physiological system affected e.g. pulmonary, infectious	30 days
Secondary	Length of Hospital Stay		30 days
Secondary	Inpatient Mortality		30 days
Secondary	Outpatient Mortality and Hospital Readmission		90 days, 1 year and 10 years.