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Clinical Trials/ISRCTN27929536
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.

Registry
who.int
Start Date
December 21, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
Italian Polispecialistic Society of Young Surgeons (Italy)

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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