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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515958-24-00
Enrollment
456
Registered
2025-04-07
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cholecystitis

Brief summary

The rate of postoperative infectious complications within 30 days from randomisation

Detailed description

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

Interventions

DRUGINVANZ 1 g powder for concentrate for solution for infusion
DRUGCiprofloxacin Fresenius Kabi 2 mg/ml infuusioneste
DRUGliuos
DRUGCefuroxime Orion Pharma 1
DRUG5 g injektio/infuusiokuiva-aine
DRUGliuosta/suspensiota varten

Sponsors

HUS-Yhtymae
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The rate of postoperative infectious complications within 30 days from randomisation

Secondary

MeasureTime frame
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

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026