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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04365491
Acronym
SnapAppy
Enrollment
4000
Registered
2020-04-28
Start date
2020-09-01
Completion date
2021-04-30
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Brief 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.

Interventions

None listed

Sponsors

Gary Alan Bass, MD PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of acute appendicitis3 monthsIncidence of acute appendicitis

Other

MeasureTime frameDescription
Length of post-operative stay in the hospital90 days
cost-analysis of treatment90 days
Post-operative (or non-operative complications)90 daysComplications related to disease and/or therapies within 90 post operative days
Number of participants with histopathological results, differences in age and clinical presentation90 days
Time to surgery90 days
Re-admission within 90 postoperative days90 days

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026