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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01015417
First Posted: November 18, 2009
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
  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 Other: No medication Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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

Enrollment: 414
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amoxicillin clavulanic 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 medication
no postoperative antibiotics
Other: No medication
no postoperative antibiotics
Other Name: No other name

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015417


Locations
France
Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire
Strasbourg, Alsace, France, 67098
Centre Hospitalier Haut-Lévêque
Bordeaux, Aquitaine, France, 33604
Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire
Clermont-Ferrand, Auvergne, France, 63003
Centre Hospitalier Côte e Nacre
Caen, Basse Normandie, France, 14033
Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire
Besançon, Doubs, France, 25030
Service de Chirurgie Digetsive Centre Hopsitalier Universitaire
Montpellier, Hérault, France, 34000
Centre Hospitalier Jean-Verdier
Bondy, Ile de France, France, 93143
Centre Hospitalier Louis Mourier
Colombes, Ile de France, France, 92700
Centre hospitalier Lariboisière
Paris 10, Ile de France, France, 75475
Service de Chirurgie Digestive et Viscérale
Paris, Ile de France, France, 75020
Centre Hospitalier Cochin
Paris, Ile de France, France, 75679
Centre Hospitalier de Saint-Germain en Laye
Poissy, Ile de France, France, 78303
Centre Hospitalier
Longjumeau, Ile de rance, France, 91161
Centre Hospitalier Dupuytren
Limoges, Limousin, France, 87042
Centre Hospitalier C.H.A.M.
Rang du Fliers, Nord pas de Calais, France, 62180
Chirurgie viscérale et urologique Centre Hospitalier
Beauvais, Oise, France, 60021
Centre hospitalier Universitaire
Angers, Pays de la Loire, France, 49933
Service de Chirurgie Viscérale et Digestive
Amiens, Picardie, France, 80054
Centre Hospitalier Timone
Marseille, Province-Alpes Côte d'Azur, France, 13000
Centre Hopitalier Général
Grenoble, Rhône-Alpes, France, 38700
Chirurgie Viscérale et Digestive
Rouen, Seine maritime, France, 76031
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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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01015417     History of Changes
Other Study ID Numbers: PHRCN09-PR-REGIMBEAU
Eudract N°2009-013470-41 ( Other Identifier: AFSSAPS )
First Submitted: November 17, 2009
First Posted: November 18, 2009
Last Update Posted: April 28, 2016
Last Verified: April 2016

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
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors


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