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The ACTIVE study: a multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27929536
Enrollment
144
Registered
2006-12-21
Start date
2007-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Acute Cholecystitis Digestive System Disorders of gallbladder, biliary tract and pancreas

Interventions

AC is a common disease. Any improvement in this field will benefit many patients reducing morbidity, mortality, conversion rate, operation time, hospital stay, postoperative pain, return to normal act

Sponsors

Italian Polispecialistic Society of Young Surgeons (Italy)
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
To evaluate the value of laparoscopic cholecystectomy to reduce hospital stay

Secondary

MeasureTime frame
1. To evaluate the value of laparoscopic cholecystectomy to reduce postoperative pain 2. To evaluate the conversion rate

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026