IRCT138805012220N1CompletedPhase 3
Infections after laparoscopic and open cholecystectomy; Ceftriaxone versus placebo; a randomized clinical trial
Vice-Chancellor for Research,Shahid Beheshti University of Medical Science0 sites130 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20 years to 80 years (—)
- Sex
- All
Inclusion Criteria
- •1-aged 20-80, 2- cholelithiasis with acute/chronic cholecystitis [based on three of the following signs; abdominal pain in the upper right quadrant, Murphy’s sign, leucocytosis > 10000/mm³, rectal temperature > 38 °C or < 36.5 °C plus, cholecystolithiasis (stones/sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall) or polyps of gallbladder], 3- admitted in Shohada-e-Tajrish Hospital, Tehran, Iran for cholecystectomy between 2006 and 2008.
- •Exclusion criteria: 1- Pregnant women, 2-patients with jaundice at the time of diagnosis, 3- coagulopathy, 4-coledocholithiasis, 5- portal hypertension, 6- diabetes mellitus, 7- immunosuppressive disorders, 8-previous biliary surgery, 9- biliary pancreatitis, 10- history of antibiotic consumption within one week before surgery, 11-allergic reaction/anaphylaxis to penicillin or cephalosporins, 12- any acute emergency interventions, 13- any contraindications for LC (previous history of abdominal surgery), 14 -conversion from LC to OC, 15- do not agree with conditions of study.
Exclusion Criteria
- Not provided
Investigators
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