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

NCT04365491 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

  • Appendicitis

Sponsors & Collaborators

  • Gary Alan Bass, MD PhD

    lead OTHER

Principal Investigators

  • Eanna J Ryan, MD MRCSI · St. Vincent's University Hospital, Dublin, Ireland

  • Shahin Mohseni, MD, PhD · Orebro University Hospital, Sweden

  • Gary A Bass, MD, MS · Dept Traumatology, Surgical Critical Care, University of Pennsylvania, Philadelphia, PA, USA

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-03-31
Completion
2021-04-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365491 on ClinicalTrials.gov