Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis (ABCAL)
Primary Purpose
Acute Lithiasic Cholecystitis Grade I or II, Symptoms Lasting for Less Than 5 Days, Required Cholecystectomy
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Amoxicillin clavulanic acid
No medication
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lithiasic Cholecystitis Grade I or II focused on measuring Acute lithiasic cholecystitis, Cholecystectomy, Postoperative antibiotherapy, Surgical site infection, Remote surgical site infection
Eligibility Criteria
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 ®
Sites / Locations
- Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire
- Centre Hospitalier Haut-Lévêque
- Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire
- Centre Hospitalier Côte e Nacre
- Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire
- Service de Chirurgie Digetsive Centre Hopsitalier Universitaire
- Centre Hospitalier Jean-Verdier
- Centre Hospitalier Louis Mourier
- Centre hospitalier Lariboisière
- Service de Chirurgie Digestive et Viscérale
- Centre Hospitalier Cochin
- Centre Hospitalier de Saint-Germain en Laye
- Centre Hospitalier
- Centre Hospitalier Dupuytren
- Centre Hospitalier C.H.A.M.
- Chirurgie viscérale et urologique Centre Hospitalier
- Centre hospitalier Universitaire
- Service de Chirurgie Viscérale et Digestive
- Centre Hospitalier Timone
- Centre Hopitalier Général
- Chirurgie Viscérale et Digestive
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Amoxicillin clavulanic acid
No medication
Arm Description
Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.
no postoperative antibiotics
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01015417
First Posted
November 17, 2009
Last Updated
April 27, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT01015417
Brief Title
Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis
Acronym
ABCAL
Official Title
Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Acute lithiasic cholecystitis, Cholecystectomy, Postoperative antibiotherapy, Surgical site infection, Remote surgical site infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amoxicillin clavulanic acid
Arm Type
Active Comparator
Arm Description
Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.
Arm Title
No medication
Arm Type
Other
Arm Description
no postoperative antibiotics
Intervention Type
Drug
Intervention Name(s)
Amoxicillin clavulanic acid
Other Intervention Name(s)
Augmentin, generic of amoxicillin clavulanic of any brand name, ATC class J01CR02
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No medication
Other Intervention Name(s)
No other name
Intervention Description
no postoperative antibiotics
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Rates of infectious complications according to duration of preoperative antibiotic
Time Frame
30 days postoperative
Title
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
Time Frame
30 days postoperative
Title
Nature of infectious complications analysis (surgical site infections, infections distance)
Time Frame
30 days postoperative
Title
Comparison of germs found in bile, the germs found in postoperative infectious complications
Time Frame
since the infectious complication persist
Title
Duration of hospitalization
Time Frame
until the release of hospitalization, otherwise at 30 days postoperative
Title
Readmission rate for surgical site infections (SSI)
Time Frame
30 days postoperative
Title
Rate of reoperation for SSI
Time Frame
30 days postoperative
Title
Overall mortality rate
Time Frame
30 days postoperative
Title
Specific mortality rates
Time Frame
30 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-marc REGIMBEAU, Pr
Organizational Affiliation
Centre Hospitalier Universitaire, Amiens
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David FUKS, Dr
Organizational Affiliation
Centre Hospitalier Universiatire Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67098
Country
France
Facility Name
Centre Hospitalier Haut-Lévêque
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33604
Country
France
Facility Name
Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Côte e Nacre
City
Caen
State/Province
Basse Normandie
ZIP/Postal Code
14033
Country
France
Facility Name
Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
Service de Chirurgie Digetsive Centre Hopsitalier Universitaire
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Facility Name
Centre Hospitalier Jean-Verdier
City
Bondy
State/Province
Ile de France
ZIP/Postal Code
93143
Country
France
Facility Name
Centre Hospitalier Louis Mourier
City
Colombes
State/Province
Ile de France
ZIP/Postal Code
92700
Country
France
Facility Name
Centre hospitalier Lariboisière
City
Paris 10
State/Province
Ile de France
ZIP/Postal Code
75475
Country
France
Facility Name
Service de Chirurgie Digestive et Viscérale
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier Cochin
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75679
Country
France
Facility Name
Centre Hospitalier de Saint-Germain en Laye
City
Poissy
State/Province
Ile de France
ZIP/Postal Code
78303
Country
France
Facility Name
Centre Hospitalier
City
Longjumeau
State/Province
Ile de rance
ZIP/Postal Code
91161
Country
France
Facility Name
Centre Hospitalier Dupuytren
City
Limoges
State/Province
Limousin
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier C.H.A.M.
City
Rang du Fliers
State/Province
Nord pas de Calais
ZIP/Postal Code
62180
Country
France
Facility Name
Chirurgie viscérale et urologique Centre Hospitalier
City
Beauvais
State/Province
Oise
ZIP/Postal Code
60021
Country
France
Facility Name
Centre hospitalier Universitaire
City
Angers
State/Province
Pays de la Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Service de Chirurgie Viscérale et Digestive
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Timone
City
Marseille
State/Province
Province-Alpes Côte d'Azur
ZIP/Postal Code
13000
Country
France
Facility Name
Centre Hopitalier Général
City
Grenoble
State/Province
Rhône-Alpes
ZIP/Postal Code
38700
Country
France
Facility Name
Chirurgie Viscérale et Digestive
City
Rouen
State/Province
Seine maritime
ZIP/Postal Code
76031
Country
France
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Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis
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