AppendicitisSnapAppyNCT04365491
European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
An observational study of Appendicitis, run by Gary Alan Bass, MD PhD at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Appendicitis
- How many people
- 4,000 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2020to 30 Apr 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
6.4 Inclusion Criteria
Adult patients (≥16 years of age) admitted for:
Acute Appendicitis
Procedures which should be included:
- Appendectomy (open, laparoscopic or robotic)
- Diagnostic laparoscopy
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- 90 Day Prospective Audit Collecting anytime during 6-month window:
- 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
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
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute appendicitis
Incidence of acute appendicitis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gary Alan Bass, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gary Alan Bass, MD PhD, European Society for Trauma and Emergency Surgery
- Investigators
- Eanna J Ryan, MD MRCSI, Study director, St Vincent's University Hospital, IrelandShahin Mohseni, MD, PhD, Study chair, Orebro University Hospital, SwedenGary A Bass, MD, MS, Principal investigator, Dept Traumatology, Surgical Critical Care, University of Pennsylvania, Philadelphia, PA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365491
- Sponsor's protocol ID
- ESTESSnapshot2020Appendix
- Acronym
- SnapAppy
- Status last verified
- Feb 2023
- First submitted
- 22 Apr 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pooled Data will be published. Subgroup analyses by disease, technique or outcome variables may be presented, but no hospital-level or surgeon-level data will be published whereby an individual patient, unit or surgeon can be identified. If local investigators would like their own unit's raw data for benchmarking purposes and local presentation/discussion, this can be made available after the end of the study; however, it will not be possible to de-anonymise patient data stored in Smart-Trial, in strict compliance with GDPR. The ESTES Cohort Studies Committee welcomes the use of the data for further research that benefits patients. Data sharing is subject to ESTES approval and appropriate safeguarding. Future sub-projects must comply with our policy of single corporate authorship e.g. "ESTES Cohort Studies Group". Authors' contributions will be highlighted in accordance with the recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals.
Publications
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.
PubMed 36693948Young 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.
PubMed 36646862
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
- ClinicalTrials.gov ID
- NCT04365491
- Acronym / sponsor ID
- SnapAppy / ESTESSnapshot2020Appendix
- Conditions
- Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Gary Alan Bass, MD PhDUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 90 Day Prospective Audit Collecting anytime during 6-month window:
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of acute appendicitis
Time frame: 3 months
Incidence of acute appendicitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 36693948Bass 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.
- Derived from this study: PubMed 36646862Young 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.
- Individual participant dataSharing planned: No. Pooled Data will be published. Subgroup analyses by disease, technique or outcome variables may be presented, but no hospital-level or surgeon-level data will be published whereby an individual patient, unit or surgeon can be identified. If local investigators would like their own unit's raw data for benchmarking purposes and local presentation/discussion, this can be made available after the end of the study; however, it will not be possible to de-anonymise patient data stored in Smart-Trial, in strict compliance with GDPR. The ESTES Cohort Studies Committee welcomes the use of the data for further research that benefits patients. Data sharing is subject to ESTES approval and appropriate safeguarding. Future sub-projects must comply with our policy of single corporate authorship e.g. "ESTES Cohort Studies Group". Authors' contributions will be highlighted in accordance with the recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eanna J Ryan, MD MRCSI study director
St Vincent's University Hospital, Ireland
Shahin Mohseni, MD, PhD study chair
Orebro University Hospital, Sweden
Gary A Bass, MD, MS principal investigator
Dept Traumatology, Surgical Critical Care, University of Pennsylvania, Philadelphia, PA, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Gary Alan Bass, MD PhD at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute appendicitis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365491, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.