๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-28

Fast Track Pathway to Accelerated Cholecystectomy (NCT04033822)

Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: P.J. Devereaux

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Hamilton General Hospital โ€” Hamilton, Ontario

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • cholecystectomy (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (4 Sites)

  • Hamilton General Hospital โ€” Hamilton, Ontario
  • Juravinski Hospital โ€” Hamilton, Ontario
  • St. Joseph's Healthcare โ€” Hamilton, Ontario
  • Lawson Health Research Institute, London Health Sciences Centre โ€” London, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Cholecystitis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—