Clinical Trial: Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe

Brief 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

Detailed Summary:

This is a multicentre national, comparative, randomized, uncontrolled, non-inferiority, unblinded (open). Two groups of patients are compared (postoperative antibiotics versus no antibiotics postoperatively) in a ratio (1:1), intention to treat.

The international consensus conference held in Tokyo, has defined precisely the ALC(acute lithiasic cholecystis)and distinguished several stages of severity. For this study, this definition of degrees of severity will be used.

ALC is defined by the association of local signs:

  • Murphy's sign
  • mass
  • pain
  • defense of the right upper quadrant
  • systemic signs (fever, leukocytosis, elevated C-reactive protein).

When the diagnosis of ALC is clinically suspected, an imaging procedure (ultrasound, a CT or MRI) is needed to confirm the diagnosis.

The morphological evidence for the diagnosis of ALC are:

  • thickened gallbladder wall (> 4 mm)
  • gallbladder distention (> 8cm by 4cm long axis and minor axis)
  • presence of stones or debris bile (sludge)
  • infiltration of fat perivesicular
  • presence of an effusion perivesicular.

In this work, early ALC was defined by a disease duration of symptoms less than 5 days. This period is defined by the early onset of abdominal pain and / or fever. These criteria will
Sponsor: Centre Hospitalier Universitaire, Amiens

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: November 17, 2009
Date Started: May 2010
Date Completion:
Last Updated: April 27, 2016
Last Verified: April 2016