A Phase 3 interventional study of Amoxicillin clavulanic acid and No medication in Acute Lithiasic Cholecystitis Grade I or II, Symptoms Lasting for Less Than 5 Days and Required Cholecystectomy, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 21 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified.
The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.
The secondary objectives are:
This is a multicentre national, comparative, randomized, uncontrolled, non-inferiority, unblinded (open). Two groups of patients are compared (postoperative antibiotics versus no antibiotics postoperatively) in a ratio (1:1), intention to treat.
The international consensus conference held in Tokyo, has defined precisely the ALC(acute lithiasic cholecystis)and distinguished several stages of severity. For this study, this definition of degrees of severity will be used.
ALC is defined by the association of local signs:
When the diagnosis of ALC is clinically suspected, an imaging procedure (ultrasound, a CT or MRI) is needed to confirm the diagnosis.
The morphological evidence for the diagnosis of ALC are:
In this work, early ALC was defined by a disease duration of symptoms less than 5 days. This period is defined by the early onset of abdominal pain and / or fever. These criteria will be collected in case report forms.
Because the events of the ALC may range from a mild disease and confined to the gallbladder disease, to a fulminant life-threatening, a new classification of the severity of ALC has been established.
This classification has 3 levels:
ALC moderately severe comprises at least one of the following criteria:
ALC(Grade III) is accompanied by dysfunction of one of the following:
Patients will be included age and suffering from:
The patient will be informed of the existence of the protocol during the consultation asking the indication of cholecystectomy for acute cholecystitis.
The medical examination and imaging procedure prior to the study correspond to a routine practice (no additional cost):
A clinical examination with collection of demographic data (gender, age, weight, size) will be noted. All co-morbidities as well as situations of potential risk of infection (diabetes type 2 steroids ongoing chronic renal failure, body mass index above 30, age over 65 years, recent surgery, serum albumin less than 35 , chronic obstructive bronchitis, tobacco weaned or unweaned? coronary insufficiency) will be noted (CRF).
A review of imaging vesicular confirming the diagnosis of acute cholecystitis, which may be based on habits and ultrasound or CT and / or MRI.
All patients then selecting checking the inclusion criteria and non-inclusion will be offered to participate in the study. They will be orally informed of the progress of the study and the various examinations, an information form will be issued.
The day of surgery, after a period of reflection varies with the date and result of surgery, the inclusion visit will be conducted and include:
Patient monitoring
A skin preparation before surgery (antiseptic shower) and surgical (debridement and antisepsis of the operative field) will be performed. The intervention will begin with a thorough exploration of the entire peritoneal cavity and gallbladder to confirm the macroscopic diagnosis of CAL. The treatment consists of cholecystectomy with complete choice of surgical approach is left to the discretion of the operator. The laparoscopic route is preferred. The realization of a systematic sampling biliary be to compare the germs found in the gallbladder and any germs found in postoperative complications. The achievement of intraoperative cholangiography will be left to the discretion of the surgical team. The need for surgical drainage (aspiration or not) will be left to local conditions and customs of the service. The operating time will be recorded and analyzed. These variables will be collected for statistical analysis (CRF).
In the waning of the intervention, patients with bile peritonitis and those with stones in the bile duct discovered on intraoperative cholangiography can not be included in the study.
Randomization will be performed in the operating theater immediately after surgery. The randomization will be done by drawing lots at the patient's statement via the Internet. It will be stratified by center and to ensure a better balance, blocks of equal size with as many patients randomized to either treatment, will be used at each center.
The combination of a nitro-imidazole is not allowed in this study. The route of administration (intravenous or oral) and the date of the relay orally depend on the clinical and biological postoperative patient are collected in case report forms. The introduction of the antibiotic will be performed in hospitals with surveillance of tolerance to the drug.
The duration of postoperative antibiotic treatment will be 5 days.
671 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 414 is above the median of 200 across 515 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.
Drug: Amoxicillin clavulanic acid
no postoperative antibiotics
Other: No medication
Postoperative administration of 2g, 3 times daily, since 5 days, of amoxicillin clavulanic acid (Augmentin or generic) oral form or parenteral form according to clinical patient and by the choice of medical teams
Also known as: Augmentin, generic of amoxicillin clavulanic of any brand name, ATC class J01CR02
no postoperative antibiotics
Also known as: No other name
All complications occurring during hospitalization or within 30 days postoperative. There are 2 main types of postoperative infectious complications: - Surgical site infections (SSI) - Systemic infections - Remote surgical site infections.
Time frame: 30 days postoperative
Rates of infectious complications according to duration of preoperative antibiotic
Time frame: 30 days postoperative
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
Time frame: 30 days postoperative
Nature of infectious complications analysis (surgical site infections, infections distance)
Time frame: 30 days postoperative
Comparison of germs found in bile, the germs found in postoperative infectious complications
Time frame: since the infectious complication persist
Duration of hospitalization
Time frame: until the release of hospitalization, otherwise at 30 days postoperative
Readmission rate for surgical site infections (SSI)
Time frame: 30 days postoperative
Rate of reoperation for SSI
Time frame: 30 days postoperative
Overall mortality rate
Time frame: 30 days postoperative
Specific mortality rates
Time frame: 30 days postoperative
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens