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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01015417
First received: November 17, 2009
Last updated: September 2, 2013
Last verified: February 2012
  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
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:


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 ]

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 Cochin
Paris, Ile de France, France, 75679
Service de Chirurgie Digestive et Viscérale
Paris, Ile de France, France, 75020
Centre hospitalier Lariboisière
Paris 10, Ile de France, France, 75475
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

Publications:
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

Additional 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: Amiens ABCAL, Eudract N°2009-013470-41
Study First Received: November 17, 2009
Last Updated: September 2, 2013
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:
Acalculous Cholecystitis
Cholecystitis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014