Cholecystitis; Gangrenous Clinical Trial
Official title:
European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2018 - Acute Complicated Biliary Disease
To explore differences in patients, techniques and outcomes across the international cohort to identify areas of practice variability in the presentation and management of acute complicated calculous biliary disease.
Background: Acute complications of biliary calculi are common, morbid and complex to manage.
Variability exists in the techniques utilised to treat these conditions at a surgeon and unit
level. This high-quality pan-European prospective audit will establish current practices and
correlate them against outcomes.
Aim: To explore differences in patients, techniques and outcomes across the international
cohort to identify areas of practice variability in the presentation and management of acute
complicated calculous biliary disease.
Endpoints: A two-stage data collection strategy collecting patient demographics, details of
operative, endocopic and radiologic intervention and outcome metrics. Several outcomes
measures will be used including mortality, surgical morbidity (including Clavien-Dindo Grade
3a and above), ICU stay and length of hospital stay.
Methods: This 30 day prospective audit will be performed across Europe in late autumn 2018,
and will be co-ordinated by the Emergency Surgery Cohort Study 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. The ESTES cohort studies
committee will assist sites to register where possible.
During the study period, all eligible patients with acute complicated biliary calculous
disease will be recorded contemporaneously and followed-up through to 60 days from their
admission. The audit will be performed using a standardised pre-determined protocol 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 multicentre, pan-European audit of acute complicated biliary calculous
disease will be delivered by emergency surgeons and trainees in an organised 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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04542512 -
Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic.
|