ESTES Snapshot Audit 2018

July 3, 2019 updated by: Gary Alan Bass, European Socierty for Trauma and Emergency Surgery

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dublin, Ireland
        • Tallaght University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  • Inclusion Criteria:

    • Adult patients (over 18 years of age) admitted for:

      • Acute gangrenous or perforated calculous cholecystitis (AAST Severity Grade II or above)
      • Choledocholithiasis or complications of cholelithiasis and/or choledocholithiasis
      • Biliary Pancreatitis
  • Procedures which should be included:

    1. Cholecystectomy (open, laparoscopic or robotic)
    2. Choledochotomy/common bile duct exploration (open, laparoscopic or robotic)
    3. Pancreatic necrosectomy
    4. Gastrojejunostomy
    5. Cyst gastrostomy
    6. Endoscopic retrograde choledochopancreatography (ERCP) or Endoscopic ultrasound (EUS)
    7. Percutaneous cholecystostomy (transhepatic or transperitoneal)
    8. Percutaneous transhepatic drainage, stone removal or stent placement
  • Exclusion Criteria:

    • Uncomplicated biliary colic
    • Biliary dyskinesia
    • Acute calculous cholecystitis (AAST Grade I)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 60 days
Overall and disease-related mortality
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Admission
Time Frame: 60 days
Intensive Care Unit admission for organ-supportive therapy
60 days
Length of hospital stay
Time Frame: 60 days
Length of hospital stay
60 days
Complications
Time Frame: 60 days
Complication related to surgical, endoscopic or radiologic intervention
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Gary A Bass, MD, MSc, MBA, Tallaght University Hospital, Dublin, Ireland
  • Principal Investigator: Shahin Mohseni, MD, PhD, Örebro University Hospital, Sweden
  • Principal Investigator: Jorge Pereira, MD, FACS, Hospital de São Teotónio, Viseu, Portugal
  • Principal Investigator: Amy Gillis, MD, MCh, FRCSC, Tallaght University Hospital, Dublin, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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