Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis
NCT ID: NCT01015417
Last Updated: 2025-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
414 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-05-31
Study Completion Date
2012-11-30
Brief Summary
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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
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
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Detailed Description
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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.
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.
Conditions
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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
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Amoxicillin clavulanic acid
Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.
Group Type
ACTIVE_COMPARATOR
Amoxicillin clavulanic acid
Intervention Type
DRUG
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
No medication
no postoperative antibiotics
Group Type
OTHER
No medication
Intervention Type
OTHER
no postoperative antibiotics
Interventions
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Amoxicillin clavulanic acid
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
DRUG
No medication
no postoperative antibiotics
Intervention Type
OTHER
Other Intervention Names
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Augmentin
generic of amoxicillin clavulanic of any brand name
ATC class J01CR02
No other name
Eligibility Criteria
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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.
* 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 ®
* 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 ®
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jean-marc REGIMBEAU, Pr
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire, Amiens
David FUKS, Dr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universiatire Amiens
Locations
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Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire
Strasbourg, Alsace, France
Site Status
Centre Hospitalier Haut-Lévêque
Bordeaux, Aquitaine, France
Site Status
Centre Hopitalier Général
Grenoble, Auvergne-Rhône-Alpes, France
Site Status
Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire
Clermont-Ferrand, Auvergne, France
Site Status
Centre Hospitalier Côte e Nacre
Caen, Basse Normandie, France
Site Status
Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire
Besançon, Doubs, France
Site Status
Centre Hospitalier C.H.A.M.
Rang-du-Fliers, Hauts-de-France, France
Site Status
Service de Chirurgie Digetsive Centre Hopsitalier Universitaire
Montpellier, Hérault, France
Site Status
Centre Hospitalier
Longjumeau, Ile de Rance, France
Site Status
Centre Hospitalier Dupuytren
Limoges, Limousin, France
Site Status
Chirurgie viscérale et urologique Centre Hospitalier
Beauvais, Oise, France
Site Status
Centre hospitalier Universitaire
Angers, Pays de la Loire Region, France
Site Status
Service de Chirurgie Viscérale et Digestive
Amiens, Picardie, France
Site Status
Centre Hospitalier Timone
Marseille, Province-Alpes Côte d'Azur, France
Site Status
Chirurgie Viscérale et Digestive
Rouen, Seine Maritime, France
Site Status
Centre Hospitalier Jean-Verdier
Bondy, Île-de-France Region, France
Site Status
Centre Hospitalier Louis Mourier
Colombes, Île-de-France Region, France
Site Status
Service de Chirurgie Digestive et Viscérale
Paris, Île-de-France Region, France
Site Status
Centre hospitalier Lariboisière
Paris, Île-de-France Region, France
Site Status
Centre Hospitalier Cochin
Paris, Île-de-France Region, France
Site Status
Centre Hospitalier de Saint-Germain en Laye
Poissy, Île-de-France Region, France
Site Status
Countries
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France
References
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Chacon JP, Criscuolo PD, Kobata CM, Ferraro JR, Saad SS, Reis C. Prospective randomized comparison of pefloxacin and ampicillin plus gentamicin in the treatment of bacteriologically proven biliary tract infections. J Antimicrob Chemother. 1990 Oct;26 Suppl B:167-72. doi: 10.1093/jac/26.suppl_b.167.
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Thompson JE Jr, Bennion RS, Roettger R, Lally KP, Hopkins JA, Wilson SE. Cefepime for infections of the biliary tract. Surg Gynecol Obstet. 1993;177 Suppl:30-4; discussion 35-40.
Reference Type
BACKGROUND
Mayumi T, Takada T, Kawarada Y, Nimura Y, Yoshida M, Sekimoto M, Miura F, Wada K, Hirota M, Yamashita Y, Nagino M, Tsuyuguchi T, Tanaka A, Gomi H, Pitt HA. Results of the Tokyo Consensus Meeting Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):114-21. doi: 10.1007/s00534-006-1163-8. Epub 2007 Jan 30.
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BACKGROUND
Eskelinen M, Ikonen J, Lipponen P. Diagnostic approaches in acute cholecystitis; a prospective study of 1333 patients with acute abdominal pain. Theor Surg 1993;8:15-20
Reference Type
BACKGROUND
Brewer BJ, Golden GT, Hitch DC, Rudolf LE, Wangensteen SL. Abdominal pain. An analysis of 1,000 consecutive cases in a University Hospital emergency room. Am J Surg. 1976 Feb;131(2):219-23. doi: 10.1016/0002-9610(76)90101-x.
Reference Type
BACKGROUND
Telfer S, Fenyo G, Holt PR, de Dombal FT. Acute abdominal pain in patients over 50 years of age. Scand J Gastroenterol Suppl. 1988;144:47-50.
Reference Type
BACKGROUND
[Acute abdominal pain. A prospective multicentric study (author's transl)]. Nouv Presse Med. 1981 Dec 19;10(46):3771-3. French.
Reference Type
BACKGROUND
Bjorvatn B. Cholecystitis--etiology and treatment--microbiological aspects. Scand J Gastroenterol Suppl. 1984;90:65-70.
Reference Type
BACKGROUND
Tokunaga Y, Nakayama N, Ishikawa Y, Nishitai R, Irie A, Kaganoi J, Ohsumi K, Higo T. Surgical risks of acute cholecystitis in elderly. Hepatogastroenterology. 1997 May-Jun;44(15):671-6.
Reference Type
BACKGROUND
Girard RM, Morin M. Open cholecystectomy: its morbidity and mortality as a reference standard. Can J Surg. 1993 Feb;36(1):75-80.
Reference Type
BACKGROUND
Addison NV, Finan PJ. Urgent and early cholecystectomy for acute gallbladder disease. Br J Surg. 1988 Feb;75(2):141-3. doi: 10.1002/bjs.1800750217.
Reference Type
BACKGROUND
Kanafani ZA, Khalife N, Kanj SS, Araj GF, Khalifeh M, Sharara AI. Antibiotic use in acute cholecystitis: practice patterns in the absence of evidence-based guidelines. J Infect. 2005 Aug;51(2):128-34. doi: 10.1016/j.jinf.2004.11.007. Epub 2005 Jan 20.
Reference Type
BACKGROUND
Lewis RT, Allan CM, Goodall RG, Marien B, Park M, Lloyd-Smith W, Wiegand FM. A single preoperative dose of cefazolin prevents postoperative sepsis in high-risk biliary surgery. Can J Surg. 1984 Jan;27(1):44-7.
Reference Type
BACKGROUND
Lykkegaard Nielsen M, Moesgaard F, Justesen T, Scheibel JH, Lindenberg S. Wound sepsis after elective cholecystectomy. Restriction of prophylactic antibiotics to risk groups. Scand J Gastroenterol. 1981;16(7):937-40. doi: 10.3109/00365528109181826.
Reference Type
BACKGROUND
Landau O, Kott I, Deutsch AA, Stelman E, Reiss R. Multifactorial analysis of septic bile and septic complications in biliary surgery. World J Surg. 1992 Sep-Oct;16(5):962-4; discussion 964-5. doi: 10.1007/BF02067003.
Reference Type
BACKGROUND
Meijer WS. Antibiotic prophylaxis in biliary tract surgery--current practice in The Netherlands. Neth J Surg. 1990 Aug;42(4):96-100.
Reference Type
BACKGROUND
Havig O, Hertzberg J. [Effect of ampicillin, chloramphenicol and penicillin + streptomycin in the treatment of acute cholecystitis]. Tidsskr Nor Laegeforen. 1975 Feb 20;95(5):298-300. No abstract available. Norwegian.
Reference Type
BACKGROUND
Kune GA, Burdon JG. Are antibiotics necessary in acute cholecystitis? Med J Aust. 1975 Oct 18;2(16):627-30.
Reference Type
BACKGROUND
Groezinger KH. Prophylactic use of mezlocillin in acute cholecystitis. Chemioterapia. 1987 Jun;6(2 Suppl):590. No abstract available.
Reference Type
BACKGROUND
Muller EL, Pitt HA, Thompson JE Jr, Doty JE, Mann LL, Manchester B. Antibiotics in infections of the biliary tract. Surg Gynecol Obstet. 1987 Oct;165(4):285-92.
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Weigand K, Koninger J, Encke J, Buchler MW, Stremmel W, Gutt CN. Acute cholecystitis - early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study. Trials. 2007 Oct 4;8:29. doi: 10.1186/1745-6215-8-29.
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Fuks D, Duhaut P, Mauvais F, Pocard M, Haccart V, Paquet JC, Millat B, Msika S, Sielezneff I, Scotte M, Chatelain D, Regimbeau JM. A retrospective comparison of older and younger adults undergoing early laparoscopic cholecystectomy for mild to moderate calculous cholecystitis. J Am Geriatr Soc. 2015 May;63(5):1010-6. doi: 10.1111/jgs.13330. Epub 2015 May 6.
Reference Type
RESULT
Regimbeau JM, Fuks D, Pautrat K, Mauvais F, Haccart V, Msika S, Mathonnet M, Scotte M, Paquet JC, Vons C, Sielezneff I, Millat B, Chiche L, Dupont H, Duhaut P, Cosse C, Diouf M, Pocard M; FRENCH Study Group. Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial. JAMA. 2014 Jul;312(2):145-54. doi: 10.1001/jama.2014.7586.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Eudract N°2009-013470-41
Identifier Type: OTHER
Identifier Source: secondary_id
PHRCN09-PR-REGIMBEAU
Identifier Type: -
Identifier Source: org_study_id
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