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

NCT04365491 | Completed DMC

• 1 other identifier: ESTESSnapshot2020Appendix
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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:

• Demographics
• Operative technique
• Use of antibiotics
• Conservative vs surgical management
• Outcomes
• 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
• 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

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Incidence of acute appendicitis

  Incidence of acute appendicitis

  3 months

Other Outcomes (6)

• Post-operative (or non-operative complications)

  90 days

• Length of post-operative stay in the hospital

  90 days

• cost-analysis of treatment

  90 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All hospitals/units performing general surgery are eligible to join this audit. No unit size or case throughput stipulations are made. Countries outside Europe can also participate in this audit. All participating centres will register with the ESTES cohort study office and will be responsible for their own local approvals process prior to the start of the data collection period. Inclusion of data sets will be subject to local approval from participating clinical Centres. Normal patient follow-up pathways can be utilised to obtain outcomes data. No additional visits or changes to normal follow-up should be made. However, local investigators should be proactive in identifying post-diagnosis. These may include reviewing the patient notes (paper and electronic) during admission and before discharge to note in-hospital complications, reviewing hospital systems to check for re-attendances or re-admissions, and reviewing post-operative radiology reports.

You may qualify if:

• Adult patients (≥16 years of age) admitted for:
• Acute Appendicitis
• Procedures which should be included:
• Appendectomy (open, laparoscopic or robotic)
• Diagnostic laparoscopy

You may not qualify if:

• Mesenteric adenitis
• Ovarian pathology
• Methods for identifying patients
• Multiple methods may be used according to local circumstances/staffing:
• Daily review of emergency department (non-operative) and operating room lists
• Daily review of team handover sheets / emergency admission lists / ward lists
• Review of operating room logbooks
• Use of electronic systems to flag any readmissions of patients identified and treated

Sponsors & Collaborators

• Gary Alan Bass, MD PhD: lead

Study Sites (1)

Tallaght University Hospital

Dublin, Ireland

Location

Related Publications (2)

• 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.

  PMID: 36693948 DERIVED

• 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.

  PMID: 36646862 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Eanna J Ryan, MD MRCSI

  St Vincent's University Hospital, Ireland

  STUDY DIRECTOR

• Shahin Mohseni, MD, PhD

  Orebro University Hospital, Sweden

  STUDY CHAIR

• Gary A Bass, MD, MS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ESTES Cohort Studies Committee Chairperson

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 28, 2020
• Study Start: September 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)