Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis
Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis
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:

 -  Rates of infectious complications according to duration of preoperative antibiotic

 -  Influence of surgical drainage after surgery for occurrence of postoperative infectious
 complications

 -  Analysis of the nature of infectious complications (surgical site infections, remote
 surgical site infections)

 -  Comparison of germs found in the bile during the postoperative infectious complications

 -  Duration of hospitalization

 -  Readmission rate for surgical site infections

 -  Rate of reoperation for surgical site infection

 -  Overall mortality rate at 30 days

 -  Mortality rates specific to 30 days
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:

 -  Murphy's sign

 -  mass

 -  pain

 -  defense of the right upper quadrant

 -  systemic signs (fever, leukocytosis, elevated C-reactive protein).

 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:

 -  thickened gallbladder wall (> 4 mm)

 -  gallbladder distention (> 8cm by 4cm long axis and minor axis)

 -  presence of stones or debris bile (sludge)

 -  infiltration of fat perivesicular

 -  presence of an effusion perivesicular.

 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 mild,

 -  ALC moderately severe

 -  ALC severe.

 -  ALC mild (Grade I) ALC mild (Grade I) corresponds to a ALC in a patient in good general
 condition, without organ dysfunction, with mild inflammatory signs. At this stage there
 are no criteria higher stages (Grade II and III).

 -  ALC moderately severe (Grade II)

 ALC moderately severe comprises at least one of the following criteria:

 -  Leukocytosis greater than 18,000 leucocytes/mm3

 -  Tense palpable mass on clinical examination at the right hypochondrium

 -  Duration of symptoms exceeding 72 hours

 -  Presence of local signs of inflammation (biliary peritonitis, perivesicular abscess,
 liver abscess, gangrenous cholecystitis, emphysematous cholecystitis)

 -  ALC severe (Grade III) (non-inclusion criteria of the study ABCAL)

 ALC(Grade III) is accompanied by dysfunction of one of the following:

 -  Dysfunction Cardiovascular: hypotension requiring treatment with dopamine ≥ 5μg/kg per
 minute or whatever dobutamine dose.

 -  Neurological dysfunction: alteration of consciousness

 -  Respiratory dysfunction: report PaO2/FiO2 <300

 -  Renal dysfunction: oliguria, creatinine> 176μmol / l

 -  Hepatocellular dysfunction: INR> 1.5

 -  Hematologic dysfunction: platelet count <100 000/mm3

 Patients will be included age and suffering from:

 -  acute lithiasic cholecystitis confirmed by morphological examination

 -  low and moderately severe (confined to the gallbladder)

 -  requiring early cholecystectomy (progression of symptoms <5 days)

 -  signed consent for participation

 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:

 -  The verification of inclusion criteria and non-inclusion

 -  A clinical examination

 -  The organization's planning examinations specific to the study. When the inclusion of a
 patient, the investigator will inform the proponent of a fax that inclusion by
 submitting the Form of Inclusion form (see report forms).

 Patient monitoring

 -  Preoperative support Preoperative prescription of antibiotics will be systematic when
 the patient will be included in the study. The preoperative antibiotic association
 include: amoxicillin-clavulanate (Augmentin ® 2gx3/jour or generic with dosage
 equivalent). In case of allergy to beta-lactam antibiotics, the patient will be excluded
 from the study. Patients will be included in the study, either before hospitalization
 (through the use of emergency shelter), either when the patient will be hospitalized in
 a department (gastroenterology, geriatrics, internal medicine, etc..). A proportion of
 patients will have already started antibiotics (prescribed by the physician, or by the
 department where the patient is hospitalized). The history of antibiotics received by
 patients will be collected in case report forms and analyzed. For these patients, after
 inclusion in the study and prior cholecystectomy, antibiotic being arrested and will be
 replaced by amoxicillin - clavulanic acid at a dose of 2gx3/jour, in the absence of
 beta-lactam antibiotics allergies . The total duration of preoperative antibiotic will
 depend on the time of surgery and should last, in all cases, less than 5 days (inclusion
 criteria). The total duration of antibiotic therapy by amoxicillin - clavulanate is
 analyzed.

 -  Postoperative support The intraoperative antibiotics will be identical to the antibiotic
 started in preoperative(amoxicillin and clavulanic acid).

 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

 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.

 -  Postoperative management - Monitoring Visits

 -  Choice of postoperative antibiotic Prescription or not postoperative antibiotic, will be
 determined by randomization. Before administration of the antibiotic, the patients
 included will be questioned on the existence of a possible allergy to beta-lactam
 antibiotics (CRF). The postoperative antibiotic therapy will be identical to the
 preoperative antibiotic therapy and include the following antibiotics: amoxicillin -
 clavulanate (Augmentin ® 2gx3/jour). Antibiotic treatment will be issued by pharmacies
 centers investigators.

 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.

 -  Support during postoperative hospitalization Patients will be clinically monitored daily
 by the surgical team. All patients have a blood test with a blood count the day after
 the operation (CRF). Other blood tests may be performed according to clinical and
 biological patient evolution. Patients may leave the service when the surgeon deems
 necessary, from the 2nd postoperative day. The antibiotic treatment Augmentin ® is
 issued by the pharmacy at each center investigator. Antibiotics will be stored and
 dispensed by pharmacies in each center. Antibiotics will be issued to the patient (1
 gram packets) at its output for the entire duration of 5 days.
Inclusion Criteria:

 -  Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder)

 -  Requiring early cholecystectomy (progression of symptoms <5 days

 -  In an adult patient (>18 years)

 -  For each patient included the consent form must have been read, understood and signed.

 Exclusion Criteria:

 -  Severe acute cholecystitis (with organ dysfunction)

 -  Acalculous cholecystitis

 -  Biliary peritonitis

 -  Abscess perivesicular

 -  Cholangitis

 -  Acute Pancreatitis

 -  Septic shock

 -  Stone of bile duct

 -  Physical or mental state does not allow participation in the study

 -  Contraindication to surgery

 -  Classification ASA (American Society of Anesthesiologists) IV-V or life expectancy <48
 hours

 -  Suspected pre-or intraoperative cancer of the gallbladder

 -  Pregnancy or breastfeeding

 -  Treatment course with methotrexate, imidazole

 -  Known history of allergy to Augmentin ®