European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis

Appendicitis Clinical Trial

— SnapAppy  

Official title:

European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365491
• Other study ID #: ESTESSnapshot2020Appendix
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2023
• Source: European Society for Trauma and Emergency Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background Acute appendicitis is an extremely common surgical emergency. Traditionally, appendicitis has been managed surgically. Recently, however, variability in management of acute appendicitis has emerged, with some clinicians practising conservative, i.e. non-operative, management in selected patients. This high-quality pan-European, prospective audit will establish current practices and correlate them against outcomes.

Aim To explore differences in patient presentation, clinical course and outcomes for acute appendicitis across international clinical Centres to identify areas of practice variability in the presentation, management and complications of acute appendicitis.

Endpoints A three-stage data collection strategy will be used in this audit. There will be a 90 day prospective period for data collection during a six month window from September 2020 to end February 2021. Data collection will consist of collecting patient demographics, details of management (conservative vs surgical) and outcomes. Several outcomes measures will be used, including surgical mortality, morbidity (Clavien-Dindo Grade 2 and above) and length of hospital stay.

The data collection points are as follows:

1. 90 Day Prospective Audit Collecting anytime during 6-month window:

• Demographics

• Operative technique

• Use of antibiotics

• Conservative vs surgical management

• Outcomes

2. All eligible patients will be followed up to 90 days from their admission

• Readmissions will be flagged and identified

• Complications within the 90 day period will be recorded

3. Patients who have a complete data set at 90 days post presentation will be followed up to the 1-year mark • Incomplete data sets will be excluded from the study

Methods: This 90 day prospective audit will be performed across Europe from September 2020 to end February 2021., and will be co-ordinated by a designated committee of European Society of Trauma and Emergency Surgery. This will be preceded by a one-week, three-Centre pilot. Sites will be asked to pre-register for the audit and will be required to obtain appropriate regional or national approvals in advance of the enrolment date.

During the study period, all eligible patients with acute appendicitis will be recorded contemporaneously and followed-up through to 90 days from their admission. The audit will be performed using a standardised pre-determined protocol, instrument and a secure online database. The report of this audit will be prepared in accordance with guidelines set by the STROBE (strengthening the reporting of observational studies in epidemiology) statement for observational studies.

Discussion: This multi-centre, snapshot audit will be delivered by emergency surgeons and trainees in an coordinated and homogenous manner. The data obtained about areas of variability in provision or practice, and how this may impact upon outcomes, will serve to improve overall patient care as well as being hypothesis generating and inform areas needing future prospective study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

6.4 Inclusion Criteria

Adult patients (=16 years of age) admitted for:

Acute Appendicitis

Procedures which should be included:

1. Appendectomy (open, laparoscopic or robotic)

2. Diagnostic laparoscopy

3. Partial right hemicolectomy (for appendiceal mass or carcinoid tumour) Exclusion Criteria

• Mesenteric adenitis

• Ovarian pathology

Methods for identifying patients

Multiple methods may be used according to local circumstances/staffing:

1. Daily review of emergency department (non-operative) and operating room lists

2. Daily review of team handover sheets / emergency admission lists / ward lists

3. Review of operating room logbooks

4. Use of electronic systems to flag any readmissions of patients identified and treated

Related Conditions & MeSH terms

• Appendicitis
• Emergencies

Locations

Country	Name	City	State
Ireland	Tallaght University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Gary Alan Bass, MD PhD

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative (or non-operative complications)	Complications related to disease and/or therapies within 90 post operative days	90 days
Other	Length of post-operative stay in the hospital		90 days
Other	cost-analysis of treatment		90 days
Other	Re-admission within 90 postoperative days		90 days
Other	Number of participants with histopathological results, differences in age and clinical presentation		90 days
Other	Time to surgery		90 days
Primary	Incidence of acute appendicitis	Incidence of acute appendicitis	3 months