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Fast Track Pathway to Accelerated Cholecystectomy

NCT04033822 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-01

No results posted yet for this study

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). Patients with AC who do not have their gallbladder surgically removed have a 30% risk of serious complications that can lead to death. Surgery is the only definitive treatment for AC, however, there is controversy regarding the ideal timing of surgery. The two main approaches are early surgery (typically within 7 days of diagnosis) or delayed surgery (7 days to 6 weeks after diagnosis). Although preliminary evidence suggests that early surgery is associated with shorter hospital length of stay, lower risk for complications, and lower costs, practice varies widely regarding the timing of surgery. The limitations of the existing studies include small sample sizes, varied definitions of early versus delayed surgery, and an imbalance of risk between study groups. The proposed pilot study aims to inform the design of a large clinical trial that will compare the outcomes of patients with AC who receive accelerated surgery (i.e., as soon as possible with a goal of surgery within 6 hours of diagnosis) with those who receive standard care.

Conditions

  • Cholecystitis
  • Cholecystectomy

Interventions

PROCEDURE

cholecystectomy

If patients are randomized to the intervention arm of the study; said patient will undergo corrective cholecystectomy surgery to correct cholecystitis as soon as possible with a goal of surgery within 6 hours of diagnosis.

Sponsors & Collaborators

  • St. Joseph's Health Care London

    collaborator OTHER

  • P.J. Devereaux

    lead OTHER

Principal Investigators

  • Flavia Kessler Borges PhD, M.D · Population Health Research Institute

  • Rahima Nenshi Msc, M.D · St. Joseph's Health Care London

  • PJ Devereaux PhD, M.D · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2022-03-31
Completion
2025-05-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033822 on ClinicalTrials.gov