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

The use of perioperative antibiotic prophylaxis in the treatment of acute cholecystitis, a randomized, multicenter, non-inferiority trial - PEANUTS 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43999
Enrollment
454
Registered
2015-11-24
Start date
2016-03-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholecystitis inflamed gallbladder

Interventions

Omitting antibiotic prophylaxis

Sponsors

Antonius Ziekenhuis Nieuwegein
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: *

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the development of postoperative infections (surgical site and distant infections) within 30 days after surgery.

Secondary

MeasureTime frame
Secondary endpoints are the individual postoperative infections, other postoperative complications, duration of hospital stay and total costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)