Children's Acute Surgical Abdomen Programme

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2032-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Children, Only Surgery Abdomen, Acute Perioperative Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nottingham Children's Hospital

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18/0342

Identifier Type: -

Identifier Source: org_study_id