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Preoperative Antibiotics for Mild or Moderate Acute Cholecystitis (POMMAC): A Non-inferiority, Open-label, Randomized Controlled Trial – Study Protocol
EU CTIS ID: 2024-515958-24-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with diagnosed mild or moderate acute cholecystitis (according to Tokyo Guidelines)
You likely can't join if
- Age under 18 years
- Class D drug-drug interactions
- Tokyo Guidelines Grade III cholecystitis (see protocol)
- subjects with reduced capacity for self-determination
- Pregnancy
- Peritonitis
See the full eligibility criteria
- Patients with diagnosed mild or moderate acute cholecystitis (according to Tokyo Guidelines)
- Age under 18 years
- Class D drug-drug interactions
- Tokyo Guidelines Grade III cholecystitis (see protocol)
- subjects with reduced capacity for self-determination
- Pregnancy
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.