A Rational Approach to Antibiotics
Acute calculous cholecystitis is one of the most common emergency surgical conditions. Early laparoscopic cholecystectomy is the standard treatment in selected patients. However, the routine use of preoperative antibiotics in mild–moderate cases remains an important clinical question. PANEL ChIMMACC aims to provide high-quality evidence to support safe, rational and evidence-based antibiotic use.
The PICO Question
The PANEL ChIMMACC trial is structured around a focused clinical question addressing the role of preoperative antibiotics in selected patients undergoing early laparoscopic cholecystectomy.
P
Population
Adult patients with mild-to-moderate acute calculous cholecystitis undergoing early laparoscopic cholecystectomy.
I
Intervention
No preoperative antibiotics.
C
Comparator
Preoperative antibiotic treatment with intravenous amoxicillin/clavulanic acid every 8 hours, according to the study protocol.
O
Outcome
30-day postoperative infectious morbidity.
Study Design
International Multicentre
Conducted across multiple centres to enhance external validity and support the real-world applicability of the study findings.
Randomized Controlled
Randomized allocation minimizes selection bias and supports a fair comparison between treatment arms.
Open-Label Design
The open-label design was chosen to enhance safety monitoring and practical feasibility in a multicentre setting, while preserving the methodological rigour of randomized allocation and standardized outcome assessment.
Phase IV Study
Pragmatic study focused on generating clinically relevant evidence to support antibiotic stewardship while maintaining patient safety in selected patients undergoing early laparoscopic cholecystectomy.
Parallel-Group
Two clearly defined intervention groups allow a direct comparison of postoperative infectious outcomes between no preoperative antibiotics and standard preoperative antibiotic treatment.
Non-Inferiority
Designed to assess whether omission of preoperative antibiotics is non-inferior to standard preoperative antibiotic treatment in selected patients undergoing early laparoscopic cholecystectomy.
Study Population
The study population includes adult patients with mild-to-moderate acute calculous cholecystitis, diagnosed according to the Tokyo Guidelines 2018, who are considered suitable for early laparoscopic cholecystectomy. Patient enrolment will begin only after ethics approval and local site activation.
Study Arms
No Preoperative Antibiotic Arm
Preoperative antibiotics are omitted before early laparoscopic cholecystectomy. Antibiotic treatment remains permitted when clinically indicated according to patient safety and standard clinical judgement.
Standard Antibiotic Arm
Patients receive preoperative intravenous amoxicillin/clavulanic acid every 8 hours according to the study protocol.
Primary Outcome
The primary outcome is 30-day postoperative infectious morbidity, defined as a composite of surgical site infection, pneumonia, urinary tract infection, and other clinically significant infectious complications.
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Follow-up is planned at postoperative day 30.
Clinical impactÂ
If non-inferiority is confirmed, PANEL ChIMMACC may support a more selective use of antibiotics in mild-to-moderate acute calculous cholecystitis, helping to reduce unnecessary antibiotic exposure while maintaining patient safety.
Interested in participating?
Centres interested in joining PANEL ChIMMACC can contact the coordinating team to receive further information, study documents, and guidance on local activation procedures.
Local Activation
Information and guidance for ethics approval and centre activation procedures.
Coordinating Centre
Division of General Surgery 1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Principal Investigator
Prof. Luca Ansaloni
Clinical Study Coordinator
Dr. Ahmed Ghaly