ESTES Snapshot Audit 2018
Condition: Cholangitis; Gallstone; Pancreatitis Gallstone; Cholecystitis; Gangrenous
MeSH terms: Pancreatitis; Cholangitis; Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Pan-European, prospective audit of consecutive patients admitted for the treatment of
             complicated calculous biliary disease over a 30-day study period. The audit shall
             include unscheduled admissions from 1 October 2018 to 31 October 2018.

          -  Commencement timeframe: The sites will start within a time window from 1 October to 31
             October 2018. Following commencement, the sites will be required to include all
             eligible consecutive patients for 30 consecutive days.

          -  Final date for operation inclusion: The sites can include admissions that occur up to
             31 October 2018.

          -  All patients will be followed for 60 days post-admission. Data collection should
             therefore be completed by 31 December 2018.

          -  As this is an observational cohort audit, no change to normal patient management is
             required.