Acute Lithiasic Cholecystitis Grade I or II Clinical Trial
— ABCALOfficial title:
Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe
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
Status | Completed |
Enrollment | 414 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 ® |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Service de Chirurgie Viscérale et Digestive | Amiens | Picardie |
France | Centre hospitalier Universitaire | Angers | Pays de la Loire |
France | Chirurgie viscérale et urologique Centre Hospitalier | Beauvais | Oise |
France | Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire | Besançon | Doubs |
France | Centre Hospitalier Jean-Verdier | Bondy | Ile de France |
France | Centre Hospitalier Haut-Lévêque | Bordeaux | Aquitaine |
France | Centre Hospitalier Côte e Nacre | Caen | Basse Normandie |
France | Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire | Clermont-Ferrand | Auvergne |
France | Centre Hospitalier Louis Mourier | Colombes | Ile de France |
France | Centre Hopitalier Général | Grenoble | Rhône-Alpes |
France | Centre Hospitalier Dupuytren | Limoges | Limousin |
France | Centre Hospitalier | Longjumeau | Ile de rance |
France | Centre Hospitalier Timone | Marseille | Province-Alpes Côte d'Azur |
France | Service de Chirurgie Digetsive Centre Hopsitalier Universitaire | Montpellier | Hérault |
France | Centre Hospitalier Cochin | Paris | Ile de France |
France | Service de Chirurgie Digestive et Viscérale | Paris | Ile de France |
France | Centre hospitalier Lariboisière | Paris 10 | Ile de France |
France | Centre Hospitalier de Saint-Germain en Laye | Poissy | Ile de France |
France | Centre Hospitalier C.H.A.M. | Rang du Fliers | Nord pas de Calais |
France | Chirurgie Viscérale et Digestive | Rouen | Seine maritime |
France | Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire | Strasbourg | Alsace |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
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* Note: There are 67 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 30 days postoperative | Yes | |
Secondary | Rates of infectious complications according to duration of preoperative antibiotic | 30 days postoperative | Yes | |
Secondary | Influence of surgical drainage after surgery for occurrence of postoperative infectious complications | 30 days postoperative | Yes | |
Secondary | Nature of infectious complications analysis (surgical site infections, infections distance) | 30 days postoperative | Yes | |
Secondary | Comparison of germs found in bile, the germs found in postoperative infectious complications | since the infectious complication persist | Yes | |
Secondary | Duration of hospitalization | until the release of hospitalization, otherwise at 30 days postoperative | Yes | |
Secondary | Readmission rate for surgical site infections (SSI) | 30 days postoperative | Yes | |
Secondary | Rate of reoperation for SSI | 30 days postoperative | Yes | |
Secondary | Overall mortality rate | 30 days postoperative | Yes | |
Secondary | Specific mortality rates | 30 days postoperative | Yes |