The ACTIVE study: a multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis in adults
Completed
- Conditions
- Acute CholecystitisDigestive SystemDisorders of gallbladder, biliary tract and pancreas
- Registration Number
- ISRCTN27929536
- Lead Sponsor
- Italian Polispecialistic Society of Young Surgeons (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the value of laparoscopic cholecystectomy to reduce hospital stay
- Secondary Outcome Measures
Name Time Method 1. To evaluate the value of laparoscopic cholecystectomy to reduce postoperative pain<br>2. To evaluate the conversion rate