Perioperative antibiotic use in the treatment of acute inflammation of the gallbladder

Conditions: Acute calculous cholecystitis
MedDRA version: 14.0Level: PTClassification code 10008612Term: CholecystitisSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-004878-29-NL

Lead Sponsor: St. Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

? Acute calculous cholecystitis, defined according to Tokyo Guidelines
? Laparoscopic cholecystectomy
? APACHE-II score 1-6
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

? < 18 years of age
? APACHE-II score = 7
? Already receiving antibiotics at time of/prior to diagnosis
? Proven allergy to cefuroxime/ metronidazole
? Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that extended postoperative antibiotic therapy does not decrease the infectious complication rate in laparoscopic cholecystectomy for acute cholecystitis. ;Secondary Objective: To demonstrate that total duration of hospital admission in patients receiving extended postoperative antibiotic therapy is significantly longer than in those receiving only a single pre-operative dose. ;Primary end point(s): Composite endpoint consisting of all infectious complications:<br>- Wound infection<br>- Intra-abdominal infection<br>- Pneumonia<br>- Urinary tract infection<br>;Timepoint(s) of evaluation of this end point: The occurence of the primary endpoint will be assessed during hospital admittance and in the outpatient clinic 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - All individual components of the composite endpoint<br>- Other complications<br>- Need for re-intervention<br>- Need for re-admission<br>- Total duration of admission<br>- Total direct and indirect costs;Timepoint(s) of evaluation of this end point: The occurence of the secondary endpoints will be assessed during hospital admittance and in the outpatient clinic 30 days after surgery.