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Clinical Trials/2024-515958-24-00
2024-515958-24-00
Not yet recruiting
Phase 3

Preoperative Antibiotics for Mild or Moderate Acute Cholecystitis (POMMAC): A Non-inferiority, Open-label, Randomized Controlled Trial – Study Protocol

HUS-Yhtymae1 site in 1 country456 target enrollmentStarted: April 7, 2025Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
HUS-Yhtymae
Enrollment
456
Locations
1
Primary Endpoint
The rate of postoperative infectious complications within 30 days from randomisation
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the rate of postoperative infectious complications in patients undergoing cholecystectomy for acute cholecystitis.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with diagnosed mild or moderate acute cholecystitis (according to Tokyo Guidelines)

Exclusion Criteria

  • •Age under 18 years
  • •Class D drug-drug interactions
  • •Tokyo Guidelines Grade III cholecystitis (see protocol)
  • •subjects with reduced capacity for self-determination
  • •Peritonitis
  • •Suspicion of cholangitis (Charcot's triad or radiologic findings)
  • •Bile duct stones
  • •Allergy to all antibiotics in protocol
  • •Antibiotics 24 hours prior to randomisation
  • •Breastfeeding women

Outcomes

Primary Outcomes

The rate of postoperative infectious complications within 30 days from randomisation

The rate of postoperative infectious complications within 30 days from randomisation

Secondary Outcomes

  • The conversion rate from laparoscopic to open cholecystectomy during the primary operation
  • The Comprehensive Complication Index according to the Clavien-Dindo Classification within 30 days postoperatively
  • A composite outcome incorporating the rate of all antibiotic-related adverse outcomes (hypersensitivity reactions, clostridium difficile diarrhea, yeast infections) within 30 days postoperatively
  • The length of stay

Investigators

Sponsor
HUS-Yhtymae
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Panu Mentula

Scientific

HUS-Yhtymae

Study Sites (1)

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