Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis
Information source: Centre Hospitalier Universitaire, Amiens
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lithiasic Cholecystitis Grade I or II; Symptoms Lasting for Less Than 5 Days; Required Cholecystectomy; Preoperative Amoxicillin Clavulanic Acid for at Most 5 Days
Intervention: amoxicillin clavulanic acid (Drug); No medication (Drug)
Phase: Phase 3
Sponsored by: Centre Hospitalier Universitaire, Amiens
Official(s) and/or principal investigator(s):
Jean-marc REGIMBEAU, Pr, Study Director, Affiliation: Centre Hospitalier Universitaire, Amiens
David FUKS, Dr, Principal Investigator, Affiliation: Centre Hospitalier Universiatire Amiens
Jean-Marc REGIMBEAU, Pr, Phone: +33 3 22 66 83 01, Email: Regimbeau.email@example.com
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
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
- 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
Official title: Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Rates of infectious complications according to duration of preoperative antibiotic
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
Nature of infectious complications analysis (surgical site infections, infections distance)
Comparison of germs found in bile, the germs found in postoperative infectious complications
Duration of hospitalization
Readmission rate for surgical site infections (SSI)
Rate of reoperation for SSI
Overall mortality rate
Specific mortality rates
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
- 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
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).
- 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 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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- Severe acute cholecystitis (with organ dysfunction)
- Acalculous cholecystitis
- Biliary peritonitis
- Abscess perivesicular
- 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
- Suspected pre-or intraoperative cancer of the gallbladder
- Pregnancy or breastfeeding
- Treatment course with methotrexate, imidazole
- Known history of allergy to Augmentin ®
Locations and Contacts
Jean-Marc REGIMBEAU, Pr, Phone: +33 3 22 66 83 01, Email: Regimbeau.firstname.lastname@example.org
Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire, Strasbourg, Alsace 67098, France; Active, not recruiting
Centre Hospitalier Haut-Lévêque, Bordeaux, Aquitaine 33604, France; Active, not recruiting
Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire, Clermont-Ferrand, Auvergne 63003, France; Recruiting
Karem SLIM, Pr, Phone: +33 4 73 75 05 32, Email: email@example.com
Karem SLIM, Pr, Principal Investigator
Centre Hospitalier Côte e Nacre, Caen, Basse Normandie 14033, France; Recruiting
Laurence CHICHE, Pr, Phone: +33 2 31 06 50 20, Email: firstname.lastname@example.org
Arnaud ALVES, Pr, Phone: +33 2 31 06 31 88, Email: email@example.com
Laurence CHICHE, Pr, Principal Investigator
Arnaud ALVES, Pr, Sub-Investigator
Gil LEBRETON, Dr, Sub-Investigator
Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire, Besançon, Doubs 25030, France; Not yet recruiting
Georges MANTION, Pr, Phone: +33 3 81 66 81 66, Email: firstname.lastname@example.org
Georges MANTION, Pr, Principal Investigator
Service de Chirurgie Digetsive Centre Hopsitalier Universitaire, Montpellier, Hérault 34000, France; Recruiting
Bertrand MILLAT, Pr, Phone: +33 4 67 33 68 63, Email: email@example.com
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Centre Hospitalier Louis Mourier, Colombes, Ile de France 92700, France; Recruiting
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Simon MSIKA, Pr, Principal Investigator
Service de Chirurgie Digestive et Viscérale, Paris, Ile de France 75020, France; Active, not recruiting
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Nicolas ABRAS, Dr, Phone: +33 5 55 05 67 13, Email: firstname.lastname@example.org
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Centre Hospitalier C.H.A.M., Rang du Fliers, Nord pas de Calais 62180, France; Recruiting
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Chirurgie viscérale et urologique Centre Hospitalier, Beauvais, Oise 60021, France; Recruiting
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Jean-Pierre ARNAUD, Pr, Phone: + 33 2 41 35 36 37, Email: firstname.lastname@example.org
Jean-Pierre ARNAUD, Pr, Principal Investigator
Service de Chirurgie Viscérale et Digestive, Amiens, Picardie 80054, France; Recruiting
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Centre Hopitalier Général, Grenoble, Rhône-Alpes 38700, France; Recruiting
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Chirurgie Viscérale et Digestive, Rouen, Seine maritime 76031, France; Recruiting
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Michel SCOTTE, Pr, Principal Investigator
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Starting date: May 2010
Last updated: February 22, 2012