ISRCTN27929536
Completed
Not Applicable
The ACTIVE study: a multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis in adults
Italian Polispecialistic Society of Young Surgeons (Italy)0 sites144 target enrollmentDecember 21, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Italian Polispecialistic Society of Young Surgeons (Italy)
- Enrollment
- 144
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients (more than 18 years)
- •2\. Clinical (pain, fever more than 37\.5°C, White Blood Cells (WBC) more than 10,000/microL), and ultrasound evidence of cholecystitis
- •3\. American Surgical Association (ASA) grade I to III patients
- •4\. Informed consent
- •5\. Less than 72 hours from onset
Exclusion Criteria
- •1\. Informed consent refusal
- •2\. Choledocholithiasis
- •3\. Generalised peritonitis
- •4\. Previous abdominal surgical procedures
- •5\. Patients with an intra\-operative findings of different pathology will be excluded from the study
- •6\. Apache II score more than ten
Outcomes
Primary Outcomes
Not specified
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