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Status:

ACTIVE_NOT_RECRUITING

Fast Track Pathway to Accelerated Cholecystectomy

Lead Sponsor:

P.J. Devereaux

Collaborating Sponsors:

St. Joseph's Health Care London

Conditions:

Cholecystitis

Cholecystectomy

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

More than 10% of Canadians have gallstones, and approximately 10% of these individuals will develop gallbladder inflammation related to gallstones, which is referred to as acute cholecystitis (AC). Pa...

Detailed Description

The prevalence of gallstones is 10% and approximately 10% of patients develop acute cholecystitis (AC). AC prevalence increases with age and complications are as high as 30% in patients who do not und...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Age ≥45 years; or age ≥18 years and \<45 years with at least one of the following co-morbidities: diabetes or chronic respiratory, cardiovascular, or renal disease;
  • Diagnosis of acute cholecystitis defined by the presence of at least 2 of the following:
  • Abdominal pain in upper right quadrant,
  • Murphy's sign,
  • Leukocytosis \>10 × 103/μl, or
  • Oral temperature \<36.5°C or \>38°C;
  • Cholelithiasis (stones/sludge);
  • Ultrasound signs of cholecystitis;
  • Acute cholecystitis that requires surgery and is diagnosed during working hours;
  • Expected to require at least an overnight hospital admission after surgery; and
  • Provide written informed consent to participate in FAST.
  • Exclusion Criteria
  • Patients requiring emergent surgery or emergent interventions for another reason;
  • Patients whose therapeutic anticoagulation is not reversible;
  • Patients with a history of heparin-induced thrombocytopenia and current use of warfarin with an INR ≥1.5;
  • Pregnant patients;
  • Previous participation in the trial.

Exclusion

    Key Trial Info

    Start Date :

    January 22 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 15 2025

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT04033822

    Start Date

    January 22 2020

    End Date

    May 15 2025

    Last Update

    May 1 2025

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Hamilton General Hospital

    Hamilton, Ontario, Canada

    2

    Juravinski Hospital

    Hamilton, Ontario, Canada

    3

    St. Joseph's Healthcare

    Hamilton, Ontario, Canada

    4

    Lawson Health Research Institute, London Health Sciences Centre

    London, Ontario, Canada