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Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

NCT01015417 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2025-09-19

No results posted yet for this study

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

Conditions

  • 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

Interventions

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

No medication

no postoperative antibiotics

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Jean-marc REGIMBEAU, Pr · Centre Hospitalier Universitaire, Amiens

  • David FUKS, Dr · Centre Hospitalier Universiatire Amiens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015417 on ClinicalTrials.gov