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A prospective, randomized, blinded, placebo-controlled study of the value of preoperative treatment with Tazocin on bacterial contamination and infectious complications in patients with acute cholecystitis undergoing acute cholecystectomy - Effects of preoperative antibiotics in acute cholecystitis

A prospective, randomized, blinded, placebo-controlled study of the value of preoperative treatment with Tazocin on bacterial contamination and infectious complications in patients with acute cholecystitis undergoing acute cholecystectomy - Effects of preoperative antibiotics in acute cholecystitis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010265-23-SE
Enrollment
150
Registered
2009-03-03
Start date
2010-10-03
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Patients with cholecystitis scheduled for acute cholecystectomy.

Interventions

Trade Name: Tazocin Product Name: Tazocin Product Code: J01 C R05 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the plac

Sponsors

Gastrocentrum kirurgi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with acute cholecystitis Planned for acute cholecystectomy. Diagnosis verifiedy by either ultrasound or computerized tomogography. Patient positive to participate. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age below 18 Pregnancy. Increased operation risk (ASA-class III or above) Withdrawal if the patient doesn't want to continue to participate.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the effects of preoperatively given Tazocin on presence of bacteria in the gallbladder of patients operated because of acute cholecystitis.;Secondary Objective: To assess if the local peritonitis in patients operated because of cholecystitis will be reduced and if this is measuered in terms of patients well being, reduced pain, improved postoperative course. ;Primary end point(s): Effects in terms of reduction in positive bacterial cultures of bile from the gallbladder and from the common bile duct. Effects of infectious postoperative complications.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026