Preoperative antibiotics for mild or moderate acute cholecystitis (POMMAC): study protocol for a non-inferiority, open-label, randomized controlled trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Evidence is lacking on the effect of preoperative antibiotic therapy on postoperative infections in acute cholecystitis. The POMMAC trial aims to investigate whether a single dose of antibiotic prophylaxis is non-inferior to continuous preoperative antibiotic therapy in terms of postoperative infections. This is a non-inferior, open-label randomized controlled trial aiming to include 456 participants. Eligible participants with mild or moderate acute cholecystitis will be randomized at a 1:1 ratio to receive either continuous or a single dose of preoperative antibiotic prophylaxis. The primary outcome is the rate of postoperative infections within 30 days postoperatively. Secondary outcomes are rates of conversion from laparoscopic to open cholecystectomy, other postoperative complications (Clavien-Dindo), a composite outcome incorporating antibiotic-related hypersensitivity reactions, Clostridium difficile diarrhea, and yeast infections within 30 days postoperatively, and the length of stay. The POMMAC trial will provide evidence on the effect of preoperative antibiotic therapy on postoperative infections in acute cholecystitis. Abstaining from unnecessary preoperative antibiotic therapy could reduce antimicrobial resistance, adverse antibiotic-related events, and healthcare expenses. EU CTIS: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-515958-24-00 protocol version 2.4. Registered on April 9th, 2025.
Source: Trials
Institutions: University of Helsinki, Helsinki University Hospital
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,790
Funder: Helsingin Yliopisto
OpenAlex ID: W7170711148
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