An observational study in Cholangitis; Gallstone, Pancreatitis Gallstone and Cholecystitis; Gangrenous, sponsored by European Society for Trauma and Emergency Surgery. Completed at 1 site in Ireland. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by European Society for Trauma and Emergency Surgery · Observational
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.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 250 is above the median of 180 across 277 observational studies indexed under Pancreatitis.
Browse Pancreatitis studies →European Society for Trauma and Emergency Surgery is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (over 18 years of age) admitted for:
Procedures which should be included:
Uncomplicated biliary colic
Mortality
Overall and disease-related mortality
Time frame: 60 days
ICU Admission
Intensive Care Unit admission for organ-supportive therapy
Time frame: 60 days
Length of hospital stay
Length of hospital stay
Time frame: 60 days
Complications
Complication related to surgical, endoscopic or radiologic intervention
Time frame: 60 days
Plan to share: Undecided
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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European Society for Trauma and Emergency Surgery