The use of perioperative antibiotic prophylaxis in the treatment of acute cholecystitis, a randomized, multicenter, non-inferiority trial

Completed

• Conditions: cholecystitis; inflamed gallbladder; 10017628

• Registration Number: NL-OMON43999
• Lead Sponsor: Antonius Ziekenhuis Nieuwegein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 454

Inclusion Criteria

* Acute calculous cholecystitis, defined as mild or moderate according to Tokyo Guidelines
* Cholecystectomy
* Written informed consent

Exclusion Criteria

* < 18 years of age
* Acalculous cholecystitis
* Acute calculous cholecystitis, defined as severe according to Tokyo Guidelines
* Patients who received antibiotic treatment on admission
* Proven allergy to cefazolin
* Pregnancy
* Immune compromised patients
* Indication for endoscopic retrograde pancreaticocholangiography (ERCP) on admission

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the development of postoperative infections<br /><br>(surgical site and distant infections) within 30 days after surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the individual postoperative infections, other<br /><br>postoperative complications, duration of hospital stay and total costs.</p><br>