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

Sponsor
Gary Alan Bass (Other)
Overall Status
Recruiting
CT.gov ID
NCT04365491
Collaborator
(none)
3,000
1
7.9
378.9

Study Details

Study Description

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

  1. 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

  1. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
    Actual Study Start Date :
    Sep 1, 2020
    Anticipated Primary Completion Date :
    Mar 31, 2021
    Anticipated Study Completion Date :
    Apr 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of acute appendicitis [3 months]

      Incidence of acute appendicitis

    Other Outcome Measures

    1. Post-operative (or non-operative complications) [90 days]

      Complications related to disease and/or therapies within 90 post operative days

    2. Length of post-operative stay in the hospital [90 days]

    3. cost-analysis of treatment [90 days]

    4. Re-admission within 90 postoperative days [90 days]

    5. Number of participants with histopathological results, differences in age and clinical presentation [90 days]

    6. Time to surgery [90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tallaght University Hospital Dublin Ireland

    Sponsors and Collaborators

    • Gary Alan Bass

    Investigators

    • Study Director: Eanna J Ryan, MD MRCSI, St. Vincent's University Hospital, Dublin, Ireland
    • Study Chair: Shahin Mohseni, MD, PhD, Orebro University Hospital, Sweden
    • Principal Investigator: Gary A Bass, MD, MS, Dept Traumatology, Surgical Critical Care, University of Pennsylvania, Philadelphia, PA, USA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Alan Bass, ESTES Cohort Studies Committee Chairperson, European Socierty for Trauma and Emergency Surgery
    ClinicalTrials.gov Identifier:
    NCT04365491
    Other Study ID Numbers:
    • ESTESSnapshot2020Appendix
    First Posted:
    Apr 28, 2020
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2021