Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

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 ®