Preoperative antibiotics for mild or moderate acute cholecystitis (POMMAC): study protocol for a non-inferiority, open-label, randomized controlled trial.
- 1Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, Helsinki, 00029, Finland.
- 2Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, Helsinki, 00029, Finland.
- 3Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, Helsinki, 00029, Finland. [email protected].
Abstract
Background
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.Methods
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.Discussion
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.Trial registration
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.
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BibTeX
@article{terho2026preoperative,
title = {{Preoperative antibiotics for mild or moderate acute cholecystitis (POMMAC): study protocol for a non-inferiority, open-label, randomized controlled trial.}},
author = {Petra Terho and Ville Sallinen and Hanna Lampela and Hanna Koppatz and Henna Sammalkorpi and Panu Mentula},
journal = {Trials},
year = {2026},
month = jul,
doi = {10.1186/s13063-026-09917-8},
url = {https://europepmc.org/article/MED/42902317},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Preoperative antibiotics for mild or moderate acute cholecystitis (POMMAC): study protocol for a non-inferiority, open-label, randomized controlled trial.
AU - Petra Terho
AU - Ville Sallinen
AU - Hanna Lampela
AU - Hanna Koppatz
AU - Henna Sammalkorpi
AU - Panu Mentula
PY - 2026
DA - 2026/07/01
JO - Trials
DO - 10.1186/s13063-026-09917-8
UR - https://europepmc.org/article/MED/42902317
AB - Background 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.Methods 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.Discussion 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.Trial registration 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.
SN - 1745-6215
ER -