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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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.
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| 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
| 30 days |
| Measure | Description | 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. |
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Inclusion Criteria:
(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:
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Children aged 1 - 16 years old undergoing emergency abdominal surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham Children's Hospital | Nottingham | NG7 2UH | United Kingdom |
There is no plan to share individual participant data with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2019 | Dec 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 90 days, 1 year and 10 years. |
| The readmission rate for children after having emergency abdominal surgery | 90 days and 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |