Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis (ABCAL)

This study is currently recruiting participants.

Verified February 2012 by Centre Hospitalier Universitaire, Amiens

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT01015417

First received: November 17, 2009

Last updated: February 22, 2012

Last verified: February 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
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	Drug: amoxicillin clavulanic acid Drug: No medication	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Amoxicillin Amoxicillin sodium

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

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. [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rates of infectious complications according to duration of preoperative antibiotic [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Nature of infectious complications analysis (surgical site infections, infections distance) [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Comparison of germs found in bile, the germs found in postoperative infectious complications [ Time Frame: since the infectious complication persist ] [ Designated as safety issue: Yes ]
Duration of hospitalization [ Time Frame: until the release of hospitalization, otherwise at 30 days postoperative ] [ Designated as safety issue: Yes ]
Readmission rate for surgical site infections (SSI) [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Rate of reoperation for SSI [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Overall mortality rate [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]
Specific mortality rates [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	392
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Amoxicillin claculanic acid Postoperative administration of 2g of Augmentin, 3 times daily for 5 days.	Drug: 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 Other Names: Augmentin generic of amoxicillin clavulanic of any brand name ATC class J01CR02
No Intervention: No medication no postoperative antibiotics	Drug: No medication no postoperative antibiotics Other Name: No other name

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 ®

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015417

Contacts

Contact: Jean-Marc REGIMBEAU, Pr	+33 3 22 66 83 01	Regimbeau.jean-marc@chu-amiens.fr
Contact: David FUKS, Dr	+33 3 22 66 79 28	d.fuks@free.fr

Locations

France
Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire	Active, not recruiting
Strasbourg, Alsace, France, 67098
Centre Hospitalier Haut-Lévêque	Active, not recruiting
Bordeaux, Aquitaine, France, 33604
Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire	Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Karem SLIM, Pr +33 4 73 75 05 32 kslim@chu-clermontferrand.fr
Principal Investigator: Karem SLIM, Pr
Centre Hospitalier Côte e Nacre	Recruiting
Caen, Basse Normandie, France, 14033
Contact: Laurence CHICHE, Pr +33 2 31 06 50 20 chiche-l@chu-caen.fr
Contact: Arnaud ALVES, Pr +33 2 31 06 31 88 alves-a@chu-caen.fr
Principal Investigator: Laurence CHICHE, Pr
Sub-Investigator: Arnaud ALVES, Pr
Sub-Investigator: Gil LEBRETON, Dr
Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire	Not yet recruiting
Besançon, Doubs, France, 25030
Contact: Georges MANTION, Pr +33 3 81 66 81 66 chirurgie-2@chu-besancon.fr
Principal Investigator: Georges MANTION, Pr
Service de Chirurgie Digetsive Centre Hopsitalier Universitaire	Recruiting
Montpellier, Hérault, France, 34000
Contact: Bertrand MILLAT, Pr +33 4 67 33 68 63 b-millat@chu-montpellier.fr
Principal Investigator: Bertrand MILLAT, Pr
Centre Hospitalier Jean-Verdier	Recruiting
Bondy, Ile de France, France, 93143
Contact: VONS Catherine, Dr +33 01 48 02 65 84 corinne.vons@jvr.aphp.fr
Contact: Christophe BARRAT, Dr +33 01 48 02 61 68 christophe.barrat@jvr.aphp.fr
Principal Investigator: Catherine VONS, Dr
Sub-Investigator: Christophe BARRAT, Dr
Centre Hospitalier Louis Mourier	Recruiting
Colombes, Ile de France, France, 92700
Contact: Simon MSIKA, Pr +33 01 47 60 63 81 simon.msika@lmr.aphp.fr
Principal Investigator: Simon MSIKA, Pr
Service de Chirurgie Digestive et Viscérale	Active, not recruiting
Paris, Ile de France, France, 75020
Centre Hospitalier Cochin	Active, not recruiting
Paris, Ile de France, France, 75679
Centre hospitalier Lariboisière	Recruiting
Paris 10, Ile de France, France, 75475
Contact: Marc POCARD, Dr +33 01 49 95 82 58 marc.pocard@Irb.aphp.fr
Contact: Karine PAUTRAT, Dr +33 01 49 95 82 58 karine.pautrat@Irb.aphp.fr
Principal Investigator: Marc POCARD, Pr
Sub-Investigator: Karine PAUTRAT, Dr
Centre Hospitalier de Saint-Germain en Laye	Not yet recruiting
Poissy, Ile de France, France, 78303
Contact: Elie CHOUILLARD, Dr +33 01 39 27 51 65 echouillard@chi-poissy-st-germain.fr
Principal Investigator: Elie CHOUILLARD, Dr
Centre Hospitalier	Recruiting
Longjumeau, Ile de rance, France, 91161
Contact: Jean-Christophe PAQUET, Dr +33 01 64 54 29 01 jcpaquetmd@yahoo.com
Principal Investigator: Jean-Christophe PAQUET, Dr
Centre Hospitalier Dupuytren	Recruiting
Limoges, Limousin, France, 87042
Contact: Muriel MATHONNET, Pr +33 5 55 05 67 13 mathonnet@unilim.fr
Contact: Nicolas ABRAS, Dr +33 5 55 05 67 13 nicolasabras@yahoo.fr
Principal Investigator: Muriel MATHONNET, Pr
Sub-Investigator: Nicolas ABRAS, Dr
Centre Hospitalier C.H.A.M.	Recruiting
Rang du Fliers, Nord pas de Calais, France, 62180
Contact: Vincent HACCART, Dr + 33 3 21 89 45 45 vhaccart@ch-montreuil.fr
Contact: Ahmed MAROUAN, Dr + 33 3 21 89 45 45 amarouan@ch-montreuil.fr
Principal Investigator: Vincent HACCART, Dr
Sub-Investigator: Ahmed MAROUAN, Dr
Chirurgie viscérale et urologique Centre Hospitalier	Recruiting
Beauvais, Oise, France, 60021
Contact: François MAUVAIS, Dr +33 3 44 11 22 42 f.mauvais@ch-beauvais.fr
Principal Investigator: François MAUVAIS, Dr
Centre hospitalier Universitaire	Recruiting
Angers, Pays de la Loire, France, 49933
Contact: Jean-Pierre ARNAUD, Pr + 33 2 41 35 36 37 jparnaud@chu-angers.fr
Principal Investigator: Jean-Pierre ARNAUD, Pr
Service de Chirurgie Viscérale et Digestive	Recruiting
Amiens, Picardie, France, 80054
Contact: Jean-Marc REGIMBEAU, Pr +33 03 22 66 83 01 Regimbeau.jean-marc@chu-amiens.fr
Contact: David FUKS, Dr +33 3 22 66 79 28 d.fuks@free.fr
Principal Investigator: Jean- Marc REGIMBEAU, Pr
Sub-Investigator: David FUKS, Dr
Centre Hospitalier Timone	Recruiting
Marseille, Province-Alpes Côte d'Azur, France, 13000
Contact: SIELEZNEFF Igor, Dr + 33 4 91 38 58 52 isielezneff@ap-hm.fr
Contact: Mehdi OUAISSI, Dr + 33 4 91 38 58 52 mouaissi@ap-hm.fr
Principal Investigator: Igor SIELEZNEFF, Pr
Sub-Investigator: Mehdi OUAISSI, Dr
Sub-Investigator: Bernard SASTRE, Pr
Sub-Investigator: Nicolas PIRRO, Dr
Sub-Investigator: Silvia CRESTI, Dr
Centre Hopitalier Général	Recruiting
Grenoble, Rhône-Alpes, France, 38700
Contact: Catherine ARVIEUX, Pr + 33 4 76 76 92 80 carvieux@chu-grenoble.fr
Contact: Fabien STENARD, Dr + 33 4 76 76 92 80 fabienstenard@gmail.com
Principal Investigator: Catherine ARVIEUX, Pr
Sub-Investigator: Fabien STENARD, Dr
Chirurgie Viscérale et Digestive	Recruiting
Rouen, Seine maritime, France, 76031
Contact: Michel SCOTTE, Pr +33 3 32 88 81 42 michel.scotte@chu-rouen.fr
Principal Investigator: Michel SCOTTE, Pr

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Study Director:	Jean-marc REGIMBEAU, Pr	Centre Hospitalier Universitaire, Amiens
Principal Investigator:	David FUKS, Dr	Centre Hospitalier Universiatire Amiens

More Information

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Responsible Party:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT01015417 History of Changes
Other Study ID Numbers:	Amiens ABCAL, Eudract N°2009-013470-41
Study First Received:	November 17, 2009
Last Updated:	February 22, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:

Acute lithiasic cholecystitis
Cholecystectomy
Postoperative antibiotherapy
Surgical site infection
Remote surgical site infection

Additional relevant MeSH terms:

Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Amoxicillin
Anti-Bacterial Agents

Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013

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