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
- Conditions
- Patients with cholecystitis scheduled for acute cholecystectomy.
- Registration Number
- EUCTR2009-010265-23-SE
- Lead Sponsor
- Gastrocentrum kirurgi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
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
Age below 18
Pregnancy.
Increased operation risk (ASA-class III or above)
Withdrawal if the patient doesn't want to continue to participate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Effects of infectious postoperative complications.
- Secondary Outcome Measures
Name Time Method