Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Same admission cholecystectomy vs initial conservative management in patients with acute cholecystitis and > 5 days of symptoms: a multicentre randomised controlled trial (BRAVE trial) |
| Participants (P) | Patients with Tokyo criteria-defined acute calculous cholecystitis and symptom onset 6-10 days before day of diagnosis |
| Intervention (I) | Initial conservative management followed by the local treatment protocol |
| Control (C) | Same-admission Laparoscopic cholecystectomy (LC), defined as LC within < 72 hours of moment of diagnosis |
| Outcome (O) | Proportion of patients experiencing at least one disease-related adverse event of grade ≥ 3, as defined by the Common Terminology Criteria for Adverse Events (CTCAE, version 6.0), within 12 months after study inclusion |
| Trial Design | |
| Sample Size | 324 patients (183 NL, 141 BE) |
| Trial duration | Study duration (FPI to CSR) 36 months |
| Budget | 440,000 € for Belgian Coordinating Centre |
Trial team
| Sponsor | Radboud University Medical Center |
| Chief Investigator | Dr P R de Reuver |
| External Partners | BCC Jessa Ziekenhuis, National Coordinating Investigator: Dr. B.M.G. Appeltans |
| Number of participating sites | 19 sites (11 NL, 8 BE) |
DOCUMENTS
References
Clinicaltrials.gov:
Webpage:
Funding scheme
