DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Status: Recruiting

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

Overall contact:
Jean-Marc REGIMBEAU, Pr, Phone: +33 3 22 66 83 01, Email: Regimbeau.jean-marc@chu-amiens.fr

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

Clinical Details

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.

Secondary outcome:

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 ®

Locations and Contacts

Jean-Marc REGIMBEAU, Pr, Phone: +33 3 22 66 83 01, Email: Regimbeau.jean-marc@chu-amiens.fr

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: kslim@chu-clermontferrand.fr
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: chiche-l@chu-caen.fr
Arnaud ALVES, Pr, Phone: +33 2 31 06 31 88, Email: alves-a@chu-caen.fr
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: chirurgie-2@chu-besancon.fr
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: b-millat@chu-montpellier.fr
Bertrand MILLAT, Pr, Principal Investigator

Centre Hospitalier Jean-Verdier, Bondy, Ile de France 93143, France; Recruiting
VONS Catherine, Dr, Phone: +33 01 48 02 65 84, Email: corinne.vons@jvr.aphp.fr
Christophe BARRAT, Dr, Phone: +33 01 48 02 61 68, Email: christophe.barrat@jvr.aphp.fr
Catherine VONS, Dr, Principal Investigator
Christophe BARRAT, Dr, Sub-Investigator

Centre Hospitalier Louis Mourier, Colombes, Ile de France 92700, France; Recruiting
Simon MSIKA, Pr, Phone: +33 01 47 60 63 81, Email: simon.msika@lmr.aphp.fr
Simon MSIKA, Pr, Principal Investigator

Service de Chirurgie Digestive et Viscérale, Paris, Ile de France 75020, France; Active, not recruiting

Centre Hospitalier Cochin, Paris, Ile de France 75679, France; Active, not recruiting

Centre hospitalier Lariboisière, Paris 10, Ile de France 75475, France; Recruiting
Marc POCARD, Dr, Phone: +33 01 49 95 82 58, Email: marc.pocard@Irb.aphp.fr
Karine PAUTRAT, Dr, Phone: +33 01 49 95 82 58, Email: karine.pautrat@Irb.aphp.fr
Marc POCARD, Pr, Principal Investigator
Karine PAUTRAT, Dr, Sub-Investigator

Centre Hospitalier de Saint-Germain en Laye, Poissy, Ile de France 78303, France; Not yet recruiting
Elie CHOUILLARD, Dr, Phone: +33 01 39 27 51 65, Email: echouillard@chi-poissy-st-germain.fr
Elie CHOUILLARD, Dr, Principal Investigator

Centre Hospitalier, Longjumeau, Ile de rance 91161, France; Recruiting
Jean-Christophe PAQUET, Dr, Phone: +33 01 64 54 29 01, Email: jcpaquetmd@yahoo.com
Jean-Christophe PAQUET, Dr, Principal Investigator

Centre Hospitalier Dupuytren, Limoges, Limousin 87042, France; Recruiting
Muriel MATHONNET, Pr, Phone: +33 5 55 05 67 13, Email: mathonnet@unilim.fr
Nicolas ABRAS, Dr, Phone: +33 5 55 05 67 13, Email: nicolasabras@yahoo.fr
Muriel MATHONNET, Pr, Principal Investigator
Nicolas ABRAS, Dr, Sub-Investigator

Centre Hospitalier C.H.A.M., Rang du Fliers, Nord pas de Calais 62180, France; Recruiting
Vincent HACCART, Dr, Phone: + 33 3 21 89 45 45, Email: vhaccart@ch-montreuil.fr
Ahmed MAROUAN, Dr, Phone: + 33 3 21 89 45 45, Email: amarouan@ch-montreuil.fr
Vincent HACCART, Dr, Principal Investigator
Ahmed MAROUAN, Dr, Sub-Investigator

Chirurgie viscérale et urologique Centre Hospitalier, Beauvais, Oise 60021, France; Recruiting
François MAUVAIS, Dr, Phone: +33 3 44 11 22 42, Email: f.mauvais@ch-beauvais.fr
François MAUVAIS, Dr, Principal Investigator

Centre hospitalier Universitaire, Angers, Pays de la Loire 49933, France; Recruiting
Jean-Pierre ARNAUD, Pr, Phone: + 33 2 41 35 36 37, Email: jparnaud@chu-angers.fr
Jean-Pierre ARNAUD, Pr, Principal Investigator

Service de Chirurgie Viscérale et Digestive, Amiens, Picardie 80054, France; Recruiting
Jean-Marc REGIMBEAU, Pr, Phone: +33 03 22 66 83 01, Email: Regimbeau.jean-marc@chu-amiens.fr
David FUKS, Dr, Phone: +33 3 22 66 79 28, Email: d.fuks@free.fr
Jean- Marc REGIMBEAU, Pr, Principal Investigator
David FUKS, Dr, Sub-Investigator

Centre Hospitalier Timone, Marseille, Province-Alpes Côte d'Azur 13000, France; Recruiting
SIELEZNEFF Igor, Dr, Phone: + 33 4 91 38 58 52, Email: isielezneff@ap-hm.fr
Mehdi OUAISSI, Dr, Phone: + 33 4 91 38 58 52, Email: mouaissi@ap-hm.fr
Igor SIELEZNEFF, Pr, Principal Investigator
Mehdi OUAISSI, Dr, Sub-Investigator
Bernard SASTRE, Pr, Sub-Investigator
Nicolas PIRRO, Dr, Sub-Investigator
Silvia CRESTI, Dr, Sub-Investigator

Centre Hopitalier Général, Grenoble, Rhône-Alpes 38700, France; Recruiting
Catherine ARVIEUX, Pr, Phone: + 33 4 76 76 92 80, Email: carvieux@chu-grenoble.fr
Fabien STENARD, Dr, Phone: + 33 4 76 76 92 80, Email: fabienstenard@gmail.com
Catherine ARVIEUX, Pr, Principal Investigator
Fabien STENARD, Dr, Sub-Investigator

Chirurgie Viscérale et Digestive, Rouen, Seine maritime 76031, France; Recruiting
Michel SCOTTE, Pr, Phone: +33 3 32 88 81 42, Email: michel.scotte@chu-rouen.fr
Michel SCOTTE, Pr, Principal Investigator

Additional Information

Related publications:

Kapoor VK, Sikora SS, Bal S. Current practice in biliary surgery: the Indian scenario. Indian J Gastroenterol. 1994 Apr;13(2):49-51.

Kanafani ZA, Khalifé 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. Epub 2005 Jan 20. Review.

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.

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.

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.

Meijer WS. Antibiotic prophylaxis in biliary tract surgery--current practice in The Netherlands. Neth J Surg. 1990 Aug;42(4):96-100.

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. Norwegian. No abstract available.

Kune GA, Burdon JG. Are antibiotics necessary in acute cholecystitis? Med J Aust. 1975 Oct 18;2(16):627-30.

Groezinger KH. Prophylactic use of mezlocillin in acute cholecystitis. Chemioterapia. 1987 Jun;6(2 Suppl):590. No abstract available.

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.

Friedlender J, Meyer P, Marti MC, Rohner A. Comparative study of ceftriaxone and cefoperazone in the treatment of acute cholecystitis. Chemotherapy. 1988;34 Suppl 1:30-3.

Lau WY, Yuen WK, Chu KW, Chong KK, Li AK. Systemic antibiotic regimens for acute cholecystitis treated by early cholecystectomy. Aust N Z J Surg. 1990 Jul;60(7):539-43.

Grant MD, Jones RC, Wilson SE, Bombeck CT, Flint LM, Jonasson O, Soroff HS, Stellato TA, Dougherty SH. Single dose cephalosporin prophylaxis in high-risk patients undergoing surgical treatment of the biliary tract. Surg Gynecol Obstet. 1992 May;174(5):347-54.

Krajden S, Yaman M, Fuksa M, Langer JC, Rowan J, Burul CJ, Wooster DL, Deitel M, Borowy ZJ, Smith LC, et al. Piperacillin versus cefazolin given perioperatively to high-risk patients who undergo open cholecystectomy: a double-blind, randomized trial. Can J Surg. 1993 Jun;36(3):245-50.

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.

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.

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. Epub 2007 Jan 30.

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

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.

Telfer S, Fenyö G, Holt PR, de Dombal FT. Acute abdominal pain in patients over 50 years of age. Scand J Gastroenterol Suppl. 1988;144:47-50.

Bjorvatn B. Cholecystitis--etiology and treatment--microbiological aspects. Scand J Gastroenterol Suppl. 1984;90:65-70.

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.

Bickel A, Rappaport A, Kanievski V, Vaksman I, Haj M, Geron N, Eitan A. Laparoscopic management of acute cholecystitis. Prognostic factors for success. Surg Endosc. 1996 Nov;10(11):1045-9.

Cox MR, Wilson TG, Luck AJ, Jeans PL, Padbury RT, Toouli J. Laparoscopic cholecystectomy for acute inflammation of the gallbladder. Ann Surg. 1993 Nov;218(5):630-4.

Eldar S, Sabo E, Nash E, Abrahamson J, Matter I. Laparoscopic cholecystectomy for the various types of gallbladder inflammation: a prospective trial. Surg Laparosc Endosc. 1998 Jun;8(3):200-7.

Gharaibeh KI, Qasaimeh GR, Al-Heiss H, Ammari F, Bani-Hani K, Al-Jaberi TM, Al-Natour S. Effect of timing of surgery, type of inflammation, and sex on outcome of laparoscopic cholecystectomy for acute cholecystitis. J Laparoendosc Adv Surg Tech A. 2002 Jun;12(3):193-8.

Lo CM, Fan ST, Liu CL, Lai EC, Wong J. Early decision for conversion of laparoscopic to open cholecystectomy for treatment of acute cholecystitis. Am J Surg. 1997 Jun;173(6):513-7.

Merriam LT, Kanaan SA, Dawes LG, Angelos P, Prystowsky JB, Rege RV, Joehl RJ. Gangrenous cholecystitis: analysis of risk factors and experience with laparoscopic cholecystectomy. Surgery. 1999 Oct;126(4):680-5; discussion 685-6.

Bedirli A, Sakrak O, Sözüer EM, Kerek M, Güler I. Factors effecting the complications in the natural history of acute cholecystitis. Hepatogastroenterology. 2001 Sep-Oct;48(41):1275-8.

Lahtinen J, Alhava EM, Aukee S. Acute cholecystitis treated by early and delayed surgery. A controlled clinical trial. Scand J Gastroenterol. 1978;13(6):673-8.

Ransohoff DF, Miller GL, Forsythe SB, Hermann RE. Outcome of acute cholecystitis in patients with diabetes mellitus. Ann Intern Med. 1987 Jun;106(6):829-32.

Meyer KA, Capos NJ, Mittelpunkt AI. Personal experinces with 1,261 cases of acute and chronic cholecystitis and cholelithiasis. Surgery. 1967 May;61(5):661-8. No abstract available.

Gagic N, Frey CF, Gaines R. Acute cholecystitis. Surg Gynecol Obstet. 1975 Jun;140(6):868-74.

Girard RM, Morin M. Open cholecystectomy: its morbidity and mortality as a reference standard. Can J Surg. 1993 Feb;36(1):75-80. Review.

Addison NV, Finan PJ. Urgent and early cholecystectomy for acute gallbladder disease. Br J Surg. 1988 Feb;75(2):141-3.

Inoue T, Mishima Y. Postoperative acute cholecystitis: a collective review of 494 cases in Japan. Jpn J Surg. 1988 Jan;18(1):35-42. Review.

Savoca PE, Longo WE, Zucker KA, McMillen MM, Modlin IM. The increasing prevalence of acalculous cholecystitis in outpatients. Results of a 7-year study. Ann Surg. 1990 Apr;211(4):433-7.

Hafif A, Gutman M, Kaplan O, Winkler E, Rozin RR, Skornick Y. The management of acute cholecystitis in elderly patients. Am Surg. 1991 Oct;57(10):648-52.

Glenn F. Surgical management of acute cholecystitis in patients 65 years of age and older. Ann Surg. 1981 Jan;193(1):56-9.

Järvinen HJ, Hästbacka J. Early cholecystectomy for acute cholecystitis: a prospective randomized study. Ann Surg. 1980 Apr;191(4):501-5.

van der Linden W, Sunzel H. Early versus delayed operation for acute cholecystitis. A controlled clinical trial. Am J Surg. 1970 Jul;120(1):7-13. No abstract available.

Norrby S, Herlin P, Holmin T, Sjödahl R, Tagesson C. Early or delayed cholecystectomy in acute cholecystitis? A clinical trial. Br J Surg. 1983 Mar;70(3):163-5. No abstract available.

Siddiqui T, MacDonald A, Chong PS, Jenkins JT. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a meta-analysis of randomized clinical trials. Am J Surg. 2008 Jan;195(1):40-7.

Kolla SB, Aggarwal S, Kumar A, Kumar R, Chumber S, Parshad R, Seenu V. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective randomized trial. Surg Endosc. 2004 Sep;18(9):1323-7. Epub 2004 Jul 7.

Lai PB, Kwong KH, Leung KL, Kwok SP, Chan AC, Chung SC, Lau WY. Randomized trial of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 1998 Jun;85(6):764-7.

Lo CM, Liu CL, Fan ST, Lai EC, Wong J. Prospective randomized study of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Ann Surg. 1998 Apr;227(4):461-7.

Johansson M, Thune A, Nelvin L, Stiernstam M, Westman B, Lundell L. Randomized clinical trial of open versus laparoscopic cholecystectomy in the treatment of acute cholecystitis. Br J Surg. 2005 Jan;92(1):44-9.

Kiviluoto T, Sirén J, Luukkonen P, Kivilaakso E. Randomised trial of laparoscopic versus open cholecystectomy for acute and gangrenous cholecystitis. Lancet. 1998 Jan 31;351(9099):321-5.

Alponat A, Kum CK, Koh BC, Rajnakova A, Goh PM. Predictive factors for conversion of laparoscopic cholecystectomy. World J Surg. 1997 Jul-Aug;21(6):629-33.

Watson JF. The role of bacterial infection in acute cholecystitis: a prospective clinical study. Mil Med. 1969 Jun;134(6):416-26. No abstract available.

Calpena Rico R, Sánchez Llinares JR, Candela Polo F, Pérez Vázquez MT, Vázquez Rojas JL, Diego Estévez M, Compañ Rosique A, Medrano Heredia J. [Bacteriologic findings as a prognostic factor in the course of acute cholecystitis] Rev Esp Enferm Apar Dig. 1989 Nov;76(5):465-70. Spanish.

Claesson B, Holmlund D, Mätzsch T. Biliary microflora in acute cholecystitis and the clinical implications. Acta Chir Scand. 1984;150(3):229-37.

Csendes A, Burdiles P, Maluenda F, Diaz JC, Csendes P, Mitru N. Simultaneous bacteriologic assessment of bile from gallbladder and common bile duct in control subjects and patients with gallstones and common duct stones. Arch Surg. 1996 Apr;131(4):389-94.

Järvinen HJ. Biliary bacteremia at various stages of acute cholecystitis. Acta Chir Scand. 1980;146(6):427-30.

Linhares MM, Paiva V, Castelo Filho A, Granero LC, Pereira CA, Machado AM, Goldenberg A, Matos D. [Study of preoperative risk factors for bacteriobilia in patients with acute calculosis cholecystitis] Rev Assoc Med Bras. 2001 Jan-Mar;47(1):70-7. French.

Thompson JE Jr, Bennion RS, Doty JE, Muller EL, Pitt HA. Predictive factors for bactibilia in acute cholecystitis. Arch Surg. 1990 Feb;125(2):261-4.

Pitt HA, Postier RG, Cameron JL. Consequences of preoperative cholangitis and its treatment on the outcome of operation for choledocholithiasis. Surgery. 1983 Sep;94(3):447-52.

Maluenda F, Csendes A, Burdiles P, Diaz J. Bacteriological study of choledochal bile in patients with common bile duct stones, with or without acute suppurative cholangitis. Hepatogastroenterology. 1989 Jun;36(3):132-5.

Kimura Y, Takada T, Kawarada Y, Nimura Y, Hirata K, Sekimoto M, Yoshida M, Mayumi T, Wada K, Miura F, Yasuda H, Yamashita Y, Nagino M, Hirota M, Tanaka A, Tsuyuguchi T, Strasberg SM, Gadacz TR. Definitions, pathophysiology, and epidemiology of acute cholangitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):15-26. Epub 2007 Jan 30.

Hirota M, Takada T, Kawarada Y, Nimura Y, Miura F, Hirata K, Mayumi T, Yoshida M, Strasberg S, Pitt H, Gadacz TR, de Santibanes E, Gouma DJ, Solomkin JS, Belghiti J, Neuhaus H, Büchler MW, Fan ST, Ker CG, Padbury RT, Liau KH, Hilvano SC, Belli G, Windsor JA, Dervenis C. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):78-82. Epub 2007 Jan 30.

Juvonen T, Kiviniemi H, Niemelä O, Kairaluoma MI. Diagnostic accuracy of ultrasonography and C reactive protein concentration in acute cholecystitis: a prospective clinical study. Eur J Surg. 1992 Jun-Jul;158(6-7):365-9.

Håkansson K, Leander P, Ekberg O, Håkansson HO. MR imaging in clinically suspected acute cholecystitis. A comparison with ultrasonography. Acta Radiol. 2000 Jul;41(4):322-8.

De Vargas Macciucca M, Lanciotti S, De Cicco ML, Coniglio M, Gualdi GF. Ultrasonographic and spiral CT evaluation of simple and complicated acute cholecystitis: diagnostic protocol assessment based on personal experience and review of the literature. Radiol Med. 2006 Mar;111(2):167-80. English, Italian.

Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. Review.

Weigand K, Köninger J, Encke J, Büchler 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.

Starting date: May 2010
Last updated: February 22, 2012

Page last updated: February 07, 2013

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012