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

NCT ID: NCT04365491

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-04-30

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.

Conditions

Appendicitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gary Alan Bass, MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Gary Alan Bass, MD PhD

ESTES Cohort Studies Committee Chairperson

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eanna J Ryan, MD MRCSI

Role: STUDY_DIRECTOR

St. Vincent's University Hospital, Dublin, Ireland

Shahin Mohseni, MD, PhD

Role: STUDY_CHAIR

Orebro University Hospital, Sweden

Gary A Bass, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dept Traumatology, Surgical Critical Care, University of Pennsylvania, Philadelphia, PA, USA

Locations

Tallaght University Hospital

Dublin, , Ireland

Countries

Ireland

References

Bass GA, Kaplan LJ, Forssten MP, Walsh TN, Cao Y, Mohseni S; ESTES SnapAppy Group. Techniques for mesoappendix transection and appendix resection: insights from the ESTES SnapAppy study. Eur J Trauma Emerg Surg. 2023 Feb;49(1):17-32. doi: 10.1007/s00068-022-02191-8. Epub 2023 Jan 24.

Reference Type: DERIVED

PMID: 36693948 (View on PubMed)

Young N, Ahl Hulme R, Forssten MP, Kaplan LJ, Walsh TN, Cao Y, Mohseni S, Bass GA; ESTES SnapAppy Group. Graded operative autonomy in emergency appendectomy mirrors case-complexity: surgical training insights from the SnapAppy prospective observational study. Eur J Trauma Emerg Surg. 2023 Feb;49(1):33-44. doi: 10.1007/s00068-022-02142-3. Epub 2023 Jan 16.

Reference Type: DERIVED

PMID: 36646862 (View on PubMed)

Other Identifiers

ESTESSnapshot2020Appendix

Identifier Type: -

Identifier Source: org_study_id