Children's Acute Surgical Abdomen Programme

NCT04602429 | Active Not Recruiting

• 1 other identifier: 18/0342
• Study Type: observational
• Target: 3,100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Nottingham Children's Hospital

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: September 30, 2019
• Primary Completion: January 31, 2022
• Study Completion (Estimated): January 31, 2032
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)